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Study of a Combination of GSK1795091 and Immunotherapies in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447314
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : July 20, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Interventions Drug: GSK1795091
Drug: GSK3174998
Drug: GSK3359609
Drug: Pembrolizumab
Enrollment 54
Recruitment Details This was a non-randomized, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors.
Pre-assignment Details Total 54 participants were enrolled in the study. GSK1795091 150 nanograms (ng), 200 and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to manufacturing issue. Part 2 was not initiated.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval. Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval. Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval. Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg. Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg. Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Period Title: Part 1 (Up to 47 Months and 13 Days)
Started 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0 0 0 0
Completed 2 1 2 0 1 0 2 0 0 0 2 3 0 0 0 0 0 0
Not Completed 7 5 7 4 1 6 3 0 0 0 5 3 0 0 0 0 0 0
Reason Not Completed
Death             6             5             4             3             1             4             2             0             0             0             4             3             0             0             0             0             0             0
Withdrawal by Subject             1             0             1             0             0             1             1             0             0             0             0             0             0             0             0             0             0             0
Disease progression             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Reason for discontinuation was not recorded in the case report form             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0
Investigator discretion             0             0             0             1             0             1             0             0             0             0             0             0             0             0             0             0             0             0
Period Title: Part 2 (Up to 47 Months and 13 Days)
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab Total
Hide Arm/Group Description Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval. Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval. Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval. Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg. Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg. Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg. Total of all reporting groups
Overall Number of Baseline Participants 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0 0 0 0 54
Hide Baseline Analysis Population Description
Part 1b and Part 1c (GSK1795091 150ng, 200ng, 250ng arms) were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue. Hence, no participants were enrolled in Part 1b and Part 1c (GSK1795091 150ng, 200ng, 250ng arms); Part 2 was not initiated.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
 0 0 0
0
   0.0%
0
   0.0%
 0 0 0 0 0 0
0
   0.0%
19 - 64 years
8
  88.9%
3
  50.0%
7
  77.8%
3
  75.0%
0
   0.0%
5
  83.3%
4
  80.0%
 0 0 0
4
  57.1%
3
  50.0%
 0 0 0 0 0 0
37
  68.5%
>=65 years
1
  11.1%
3
  50.0%
2
  22.2%
1
  25.0%
2
 100.0%
1
  16.7%
1
  20.0%
 0 0 0
3
  42.9%
3
  50.0%
 0 0 0 0 0 0
17
  31.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 54 participants
Female
4
  44.4%
3
  50.0%
3
  33.3%
2
  50.0%
0
   0.0%
4
  66.7%
3
  60.0%
 0 0 0
5
  71.4%
4
  66.7%
 0 0 0 0 0 0
28
  51.9%
Male
5
  55.6%
3
  50.0%
6
  66.7%
2
  50.0%
2
 100.0%
2
  33.3%
2
  40.0%
 0 0 0
2
  28.6%
2
  33.3%
 0 0 0 0 0 0
26
  48.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 54 participants
Asian - East Asian Heritage
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
 0 0 0
0
   0.0%
0
   0.0%
 0 0 0 0 0 0
1
   1.9%
Asian - Central/South Asian Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
 0 0 0
0
   0.0%
1
  16.7%
 0 0 0 0 0 0
1
   1.9%
White - Arabic/North African Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
 0 0 0
1
  14.3%
0
   0.0%
 0 0 0 0 0 0
1
   1.9%
White - White/Caucasian/European Heritage
6
  66.7%
6
 100.0%
7
  77.8%
4
 100.0%
2
 100.0%
5
  83.3%
5
 100.0%
 0 0 0
6
  85.7%
5
  83.3%
 0 0 0 0 0 0
46
  85.2%
Unknown
2
  22.2%
0
   0.0%
2
  22.2%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
 0 0 0
0
   0.0%
0
   0.0%
 0 0 0 0 0 0
5
   9.3%
1.Primary Outcome
Title Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab.
Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
9
 100.0%
6
 100.0%
9
 100.0%
4
 100.0%
1
  50.0%
6
 100.0%
5
 100.0%
5
  71.4%
6
 100.0%
STEAEs
1
  11.1%
2
  33.3%
5
  55.6%
1
  25.0%
0
   0.0%
2
  33.3%
2
  40.0%
3
  42.9%
2
  33.3%
2.Primary Outcome
Title Part 2: Number of Participants With TEAEs and STEAEs
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Part 1: Number of Participants With Dose-limiting Toxicity (DLT)
Hide Description An adverse event was considered to be a DLT if it was considered by investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment and met one of the criteria: hematologic toxicity-Grade4 neutropenia of >7 days duration or febrile neutropenia, Grade 4 anemia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, non-hematologic toxicity-Grade 4 toxicity, Grade 3 toxicity that does not resolve to <=Grade 1 or Baseline within 14 days despite optimal supportive care, alanine aminotransferase (ALT) >=5 times upper limit of normal (ULN), ALT >=3 times ULN persists for >=4 weeks, ALT >=3 times ULN and bilirubin >=2 times ULN (>35 percent [%] direct bilirubin), ALT >=3 times ULN and international normalized ratio (INR) >1.5, ALT >=3 times ULN associated with symptoms (new or worsening) believed to be related to liver injury or hypersensitivity.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
4.Primary Outcome
Title Part 1: Number of Participants With TEAEs Leading to Discontinuation
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
1
  16.7%
5.Primary Outcome
Title Part 2: Number of Participants With TEAEs Leading to Discontinuation
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
4
  44.4%
2
  33.3%
1
  11.1%
1
  25.0%
0
   0.0%
2
  33.3%
2
  40.0%
4
  57.1%
2
  33.3%
7.Primary Outcome
Title Part 2: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays
Hide Description An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hide Description Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), monocytes (Mono), eosinophils (Eosino), basophils (Baso), hemoglobin (Hb), hematocrit (Hct), erythrocytes (Erythro), erythrocyte mean corpuscular volume (EMCV), erythrocyte mean corpuscular hemoglobin (EMCH) and platelet count (PC). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (D to L) (value below lower limit of normal range [LNR]) and increase to high (I to H) (value above upper LNR). Participants were counted twice if participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Time Frame Baseline (Day 1: Pre-dose) and up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  37.5%
0
   0.0%
1
  11.1%
1
  25.0%
0
   0.0%
1
  16.7%
1
  20.0%
3
  42.9%
2
  33.3%
Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
4
  50.0%
1
  16.7%
3
  33.3%
0
   0.0%
0
   0.0%
4
  66.7%
0
   0.0%
1
  14.3%
1
  16.7%
Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  12.5%
1
  16.7%
1
  11.1%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
3
  50.0%
Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
  11.1%
1
  25.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  12.5%
2
  33.3%
1
  11.1%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
2
  33.3%
Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 8 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  12.5%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
0
   0.0%
1
  11.1%
1
  25.0%
0
   0.0%
0
   0.0%
1
  20.0%
2
  28.6%
0
   0.0%
Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
0
   0.0%
3
  33.3%
1
  25.0%
0
   0.0%
3
  50.0%
1
  20.0%
4
  57.1%
2
  33.3%
Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
2
  33.3%
2
  22.2%
1
  25.0%
0
   0.0%
1
  16.7%
2
  40.0%
2
  28.6%
2
  33.3%
Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
2
  33.3%
3
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
1
  20.0%
2
  28.6%
0
   0.0%
EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
1
  16.7%
4
  44.4%
1
  25.0%
0
   0.0%
2
  33.3%
2
  40.0%
2
  28.6%
2
  33.3%
EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
  16.7%
1
  20.0%
1
  14.3%
3
  50.0%
9.Primary Outcome
Title Part 2: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hide Description Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin and platelet count.
Time Frame Baseline (Day 1: Pre-dose) and up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Primary Outcome
Title Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Hide Description Blood samples were collected for the analysis of following chemistry parameters: urea, creatinine (Cr), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), ALT, alkaline phosphatase (ALP), bilirubin (Bil), direct bilirubin (D.Bil), protein, albumin (Alb), C-reactive protein (CRP) and Creatinine Clearance (CrCl). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (value below the lower LNR), and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst case on therapy for categories decrease to low and increase to high is presented.
Time Frame Baseline (Day 1: Pre-dose) and up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
1
  16.7%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
  14.3%
1
  16.7%
Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
1
  16.7%
1
  11.1%
1
  25.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
2
  33.3%
Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
0
   0.0%
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  57.1%
1
  16.7%
Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
4
  44.4%
2
  33.3%
0
   0.0%
1
  25.0%
0
   0.0%
1
  16.7%
1
  20.0%
0
   0.0%
0
   0.0%
Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
0
   0.0%
1
  11.1%
2
  50.0%
1
  50.0%
2
  33.3%
1
  20.0%
1
  14.3%
2
  33.3%
Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
2
  33.3%
Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
2
  22.2%
0
   0.0%
0
   0.0%
3
  50.0%
0
   0.0%
0
   0.0%
1
  16.7%
Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
1
  16.7%
2
  22.2%
1
  25.0%
0
   0.0%
2
  33.3%
1
  20.0%
3
  42.9%
2
  33.3%
Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
1
  16.7%
1
  11.1%
0
   0.0%
1
  50.0%
1
  16.7%
0
   0.0%
2
  28.6%
0
   0.0%
Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
3
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
  16.7%
AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
2
  33.3%
2
  22.2%
2
  50.0%
0
   0.0%
2
  33.3%
0
   0.0%
2
  28.6%
1
  16.7%
ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
1
  16.7%
3
  33.3%
2
  50.0%
0
   0.0%
3
  50.0%
1
  20.0%
0
   0.0%
1
  16.7%
ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
1
  16.7%
2
  22.2%
1
  25.0%
0
   0.0%
0
   0.0%
1
  20.0%
2
  28.6%
0
   0.0%
Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
1
  16.7%
Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
2
  28.6%
0
   0.0%
D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
0
   0.0%
2
  22.2%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
0
   0.0%
1
  11.1%
2
  50.0%
0
   0.0%
2
  33.3%
0
   0.0%
3
  42.9%
1
  16.7%
Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
1
  16.7%
Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
2
  22.2%
2
  33.3%
2
  22.2%
2
  50.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  14.3%
2
  33.3%
Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
3
  33.3%
1
  16.7%
2
  22.2%
0
   0.0%
1
  50.0%
1
  16.7%
0
   0.0%
1
  14.3%
1
  16.7%
CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 Number Analyzed 1 participants 2 participants 3 participants 1 participants 1 participants 4 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 Number Analyzed 1 participants 2 participants 3 participants 1 participants 1 participants 4 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Part 2: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Hide Description Blood samples were planned to be collected for the analysis of following chemistry parameters: urea, creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, direct bilirubin, protein, albumin, C-reactive protein and Creatinine Clearance.
Time Frame Baseline (Day 1: Pre-dose) and up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Primary Outcome
Title Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Hide Description Urine samples were collected for the analysis of following urinalysis parameters: glucose (Glu), protein (Pro), occult blood (OB), ketones, potential of hydrogen (pH) and specific gravity (SpGr) by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Data was categorized as decrease to low (value below the lower LNR) and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 Number Analyzed 9 participants 5 participants 8 participants 1 participants 2 participants 4 participants 2 participants 0 participants 0 participants 0 participants 0 participants 5 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 Number Analyzed 9 participants 5 participants 8 participants 1 participants 2 participants 4 participants 2 participants 0 participants 0 participants 0 participants 0 participants 5 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 Number Analyzed 9 participants 2 participants 7 participants 1 participants 2 participants 4 participants 0 participants 0 participants 0 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 Number Analyzed 9 participants 2 participants 7 participants 1 participants 2 participants 4 participants 0 participants 0 participants 0 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants
3
  33.3%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 Number Analyzed 4 participants 5 participants 8 participants 1 participants 1 participants 4 participants 2 participants 0 participants 0 participants 0 participants 1 participants 4 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 Number Analyzed 4 participants 5 participants 8 participants 1 participants 1 participants 4 participants 2 participants 0 participants 0 participants 0 participants 1 participants 4 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 Number Analyzed 9 participants 5 participants 8 participants 1 participants 2 participants 4 participants 2 participants 0 participants 0 participants 0 participants 0 participants 5 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 Number Analyzed 9 participants 5 participants 8 participants 1 participants 2 participants 4 participants 2 participants 0 participants 0 participants 0 participants 0 participants 5 participants 0 participants 0 participants 0 participants
3
  33.3%
0
   0.0%
3
  37.5%
1
 100.0%
0
   0.0%
1
  25.0%
1
  50.0%
0
   0.0%
pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
  11.1%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
  16.7%
SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 Number Analyzed 9 participants 6 participants 9 participants 4 participants 2 participants 6 participants 5 participants 0 participants 0 participants 0 participants 7 participants 6 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
13.Primary Outcome
Title Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Hide Description Urine samples were planned to be collected for the analysis of following urine parameters: glucose, protein, occult blood, ketones, potential of hydrogen and specific gravity by dipstick method.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Primary Outcome
Title Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria
Hide Description Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured in a semi-supine position after 5 minutes rest for the participants. SBP: Category1 (>140 and <161 millimeter of mercury[mmHg]), Category 2 (>=161 and <181 mmHg), Category3 (>=181 mmHg); DBP: Category1 (>90 and <101 mmHg), Category 2 (>=101 and <111 mmHg), Category 3 (>=111 mmHg); PR: Category 1 (>101 and <116 beats per minutes[bpm]), Category 2 (>=116 and <131 bpm), Category 3 (>=131 bpm); BT: Category 1 (>38.0 and <38.6 degrees Celsius), Category 2 (>=38.6 and <39.1 degrees Celsius), Category 3 (>=39.1 degrees Celsius). Data for any increase in category at worst case on therapy is presented.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Any increase, SBP
7
  77.8%
3
  50.0%
6
  66.7%
3
  75.0%
1
  50.0%
1
  16.7%
2
  40.0%
2
  28.6%
3
  50.0%
Any increase, DBP
1
  11.1%
1
  16.7%
3
  33.3%
1
  25.0%
1
  50.0%
1
  16.7%
0
   0.0%
0
   0.0%
3
  50.0%
Any increase, Pulse rate
2
  22.2%
1
  16.7%
4
  44.4%
1
  25.0%
0
   0.0%
1
  16.7%
2
  40.0%
1
  14.3%
2
  33.3%
Any increase, Body temperature
1
  11.1%
1
  16.7%
2
  22.2%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
15.Primary Outcome
Title Part 2: Number of Participants With Vital Signs Any Increases From Baseline According to Markedly Abnormal Criteria
Hide Description Vital signs including SBP, DBP, pulse rate and body temperature were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Primary Outcome
Title Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria
Hide Description Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest for the participants. For SBP: a decrease in Category was defined as <80 mmHg decrease from Baseline; DBP: decrease defined as Category (<50 mmHg decrease from Baseline); pulse rate: decrease defined as Category (<45 bpm decrease from Baseline). Data for decrease in category at worst case on therapy is presented.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Any decrease, SBP
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any decrease, DBP
2
  22.2%
1
  16.7%
1
  11.1%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
Any decrease, Pulse rate
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
17.Primary Outcome
Title Part 2: Number of Participants With Vital Signs Any Decreases From Baseline According to Markedly Abnormal Criteria
Hide Description Vital signs including SBP, DBP and pulse rate were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Primary Outcome
Title Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria
Hide Description 12-lead electrocardiogram (ECG) was obtained at indicated time point using an automated ECG machine that measured QTcF interval. QTc parameters were graded according to National Cancer Institute - CTCAE version 4.0. Grade 1 (>450 milliseconds [msec]), Grade 2 (>480 msec), Grade 3 (>500 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case on therapy is presented.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 3 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
2
  22.2%
1
  16.7%
2
  22.2%
0
   0.0%
0
   0.0%
3
  50.0%
0
   0.0%
1
  14.3%
1
  16.7%
19.Primary Outcome
Title Part 2: Number of Participants With Any QTcF Interval Increases From Baseline According to Markedly Abnormal Criteria
Hide Description 12-lead ECG was planned to be performed to measure QTcF interval.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Part 1: Objective Response Rate
Hide Description Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time Frame Up to 47 months and 13 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Number
Unit of Measure: Percentage of participants
11.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 33.3
21.Secondary Outcome
Title Part 2: Objective Response Rate
Hide Description Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of CR or PR evaluated using RECIST v 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time Frame Up to 47 months and 13 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Part 1: Disease Control Rate
Hide Description Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Time Frame Up to 47 months and 13 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 9 6 9 4 2 6 5 0 0 0 7 6 0 0 0
Measure Type: Number
Unit of Measure: Percentage of participants
44.4 33.3 33.3 25.0 0.0 16.7 20.0 14.3 33.3
23.Secondary Outcome
Title Part 2: Disease Control Rate
Hide Description Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Time Frame Up to 47 months and 13 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Arm/Group Title Part 2a: GSK1795091 + 24 mg GSK3174998 Part 2b: GSK1795091 + 80 mg GSK3359609 Part 2c: GSK1795091 + 200 mg Pembrolizumab
Hide Arm/Group Description:
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Part 1: Time to Response
Hide Description Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Time Frame Up to 47 months and 13 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, time to response could not be calculated as no participants had a confirmed CR or PR with in these arms.
Arm/Group Title Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Hide Arm/Group Description:
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
Overall Number of Participants Analyzed 1 0 0 0 0 0 0 0 0 0 0 2 0