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A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer

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: NCT03206073
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Results First Posted : October 26, 2021
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Tim Greten, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Colorectal Carcinoma
Colorectal Adenocarcinoma
Refractory Cancer
Colorectal Neoplasms
Interventions Drug: Durvalumab
Drug: Tremelimumab
Biological: Pexa-Vec
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu) Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu) Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu) Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Period Title: Overall Study
Started 4 12 4 14
Completed 3 11 0 14
Not Completed 1 1 4 0
Reason Not Completed
Participant Noncompliance             0             1             0             0
Unable to complete the dose limiting toxicity period             1             0             0             0
Death             0             0             1             0
Taken off active treatment             0             0             3             0
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg Total
Hide Arm/Group Description Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu) Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu) Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu) Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu) Total of all reporting groups
Overall Number of Baseline Participants 4 12 4 14 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 4 participants 14 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
9
  75.0%
3
  75.0%
12
  85.7%
28
  82.4%
>=65 years
0
   0.0%
3
  25.0%
1
  25.0%
2
  14.3%
6
  17.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 12 participants 4 participants 14 participants 34 participants
49.46  (5.38) 56.17  (10.29) 55.89  (12.87) 54.93  (12.66) 54.39  (11.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 4 participants 14 participants 34 participants
Female
2
  50.0%
8
  66.7%
1
  25.0%
9
  64.3%
20
  58.8%
Male
2
  50.0%
4
  33.3%
3
  75.0%
5
  35.7%
14
  41.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 4 participants 14 participants 34 participants
Hispanic or Latino
0
   0.0%
1
   8.3%
0
   0.0%
1
   7.1%
2
   5.9%
Not Hispanic or Latino
4
 100.0%
11
  91.7%
4
 100.0%
12
  85.7%
31
  91.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
1
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 4 participants 14 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  25.0%
0
   0.0%
0
   0.0%
2
  14.3%
3
   8.8%
Native Hawaiian or Other Pacific Islander
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
Black or African American
0
   0.0%
4
  33.3%
1
  25.0%
3
  21.4%
8
  23.5%
White
2
  50.0%
8
  66.7%
3
  75.0%
9
  64.3%
22
  64.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 12 participants 4 participants 14 participants 34 participants
4 12 4 14 34
1.Primary Outcome
Title Number of Participants With Grade 1-5 Adverse Events
Hide Description Number of participants with Grade 1-5 Adverse events. Grade 1 is mild, Grade 2 is moderate, Grade 3 severe or medically significant, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event.
Time Frame 30 days after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description:
Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Overall Number of Participants Analyzed 4 12 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
4
 100.0%
12
 100.0%
4
 100.0%
13
  92.9%
Grade 2
4
 100.0%
12
 100.0%
4
 100.0%
14
 100.0%
Grade 3
4
 100.0%
9
  75.0%
3
  75.0%
10
  71.4%
Grade 4
1
  25.0%
2
  16.7%
2
  50.0%
3
  21.4%
Grade 5
1
  25.0%
1
   8.3%
1
  25.0%
1
   7.1%
2.Secondary Outcome
Title Percentage of Participants With 5 Month Progression-free Survival
Hide Description Median amount of time subject survives without disease progression after treatment at 5 months. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description:
Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Overall Number of Participants Analyzed 4 12 4 14
Measure Type: Number
Unit of Measure: percentage of participants
0 8.3 0 7.1
3.Secondary Outcome
Title Overall Progression-free Survival
Hide Description Median amount of time subject survives without disease progression after treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Time Frame At progression, approximately 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description:
Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Overall Number of Participants Analyzed 4 12 4 14
Median (Full Range)
Unit of Measure: Months
3
(0.8 to 3.2)
2.3
(1.3 to 9.6)
2.25
(1.1 to 2.8)
1.65
(0.2 to 5.5)
4.Secondary Outcome
Title Overall Survival
Hide Description Median amount of time subject survives after therapy.
Time Frame Death, an average of 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description:
Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Overall Number of Participants Analyzed 4 12 4 14
Median (Full Range)
Unit of Measure: Months
6.2
(1.1 to 17.3)
8.6
(3.7 to 26.3)
6.0
(1.1 to 12.4)
5.2
(2.1 to 18.8)
5.Secondary Outcome
Title Number of Participants With Response
Hide Description Changes in tumor size and occurrence of metastases was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). And Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Time Frame Every 2 months until disease progression or intolerable toxicity, approximately 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description:
Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Overall Number of Participants Analyzed 4 12 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
Stable Disease
0
   0.0%
0
   0.0%
1
  25.0%
1
   7.1%
Progressive Disease
3
  75.0%
10
  83.3%
2
  50.0%
9
  64.3%
Unevaluable
1
  25.0%
1
   8.3%
1
  25.0%
4
  28.6%
6.Other Pre-specified Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3)
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 20 months and 3 days for 1/Arm A1, 30 months and 27 days for 2/Arm A2, 14 months for 3/Arm B1, and 13 months and 21 days for 4/Arm B2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description:
Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
Overall Number of Participants Analyzed 4 12 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
12
 100.0%
4
 100.0%
14
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 20 months and 3 days for 1/Arm A1, 30 months and 27 days for 2/Arm A2, 14 months for 3/Arm B1, and 13 months and 21 days for 4/Arm B2.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Hide Arm/Group Description Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu) Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu) Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu) Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
All-Cause Mortality
1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)      11/12 (91.67%)      4/4 (100.00%)      10/14 (71.43%)    
Hide Serious Adverse Events
1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      3/12 (25.00%)      3/4 (75.00%)      6/14 (42.86%)    
Gastrointestinal disorders         
Abdominal distension † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Abdominal pain † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Ascites † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Colitis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Constipation † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Diarrhea † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Duodenal hemorrhage † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Gastrointestinal disorders - Other, immune mediated colitis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Nausea † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Rectal hemorrhage † 1  0/4 (0.00%)  0 1/12 (8.33%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0
Vomiting † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
General disorders         
Fatigue † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Infections and infestations         
Sepsis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Injury, poisoning and procedural complications         
Fall † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Investigations         
Alanine aminotransferase increased † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Aspartate aminotransferase increased † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Blood bilirubin increased † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
CPK increased † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Cardiac troponin I increased † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Creatinine increased † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia † 1  2/4 (50.00%)  2 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Dehydration † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 1/4 (25.00%)  2 1/14 (7.14%)  1
Hyponatremia † 1  2/4 (50.00%)  2 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myositis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Non-cardiac chest pain † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Malignant † 1  1/4 (25.00%)  1 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Malignant neoplasm † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, PD † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Psychiatric disorders         
Confusion † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Delirium † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Hypoxia † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Pleural effusion † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Vascular disorders         
Hypotension † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
1
Term from vocabulary, CTCAE (4.3)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg 2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg 3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg 4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      12/12 (100.00%)      4/4 (100.00%)      14/14 (100.00%)    
Blood and lymphatic system disorders         
Anemia † 1  3/4 (75.00%)  9 12/12 (100.00%)  42 4/4 (100.00%)  8 10/14 (71.43%)  36
Cardiac disorders         
Pericardial effusion † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Sinus bradycardia † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Sinus tachycardia † 1  2/4 (50.00%)  3 6/12 (50.00%)  14 2/4 (50.00%)  4 11/14 (78.57%)  36
Ear and labyrinth disorders         
Ear pain † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Endocrine disorders         
Hyperthyroidism † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Hypothyroidism † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Eye disorders         
Eye disorders - Other, Black dots in vision † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Photophobia † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Gastrointestinal disorders         
Abdominal distension † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Abdominal pain † 1  3/4 (75.00%)  3 2/12 (16.67%)  4 2/4 (50.00%)  5 4/14 (28.57%)  5
Ascites † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 2/14 (14.29%)  2
Bloating † 1  1/4 (25.00%)  1 1/12 (8.33%)  1 1/4 (25.00%)  1 2/14 (14.29%)  2
Colitis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Constipation † 1  2/4 (50.00%)  3 7/12 (58.33%)  7 2/4 (50.00%)  2 2/14 (14.29%)  2
Diarrhea † 1  1/4 (25.00%)  2 1/12 (8.33%)  2 1/4 (25.00%)  3 1/14 (7.14%)  1
Dry mouth † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 1/4 (25.00%)  1 2/14 (14.29%)  2
Dyspepsia † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Flatulence † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Gastritis † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Gastroesophageal reflux disease † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Gastrointestinal disorders - Other, Abdominal Cramping † 1  2/4 (50.00%)  2 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Gastrointestinal disorders - Other, Cramp † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Ileus † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Mucositis oral † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Nausea † 1  3/4 (75.00%)  6 5/12 (41.67%)  9 4/4 (100.00%)  4 11/14 (78.57%)  23
Oral pain † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Rectal hemorrhage † 1  1/4 (25.00%)  2 1/12 (8.33%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0
Rectal pain † 1  1/4 (25.00%)  1 1/12 (8.33%)  3 0/4 (0.00%)  0 1/14 (7.14%)  1
Stomach pain † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Toothache † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Vomiting † 1  2/4 (50.00%)  4 4/12 (33.33%)  5 3/4 (75.00%)  4 10/14 (71.43%)  16
General disorders         
Chills † 1  3/4 (75.00%)  6 9/12 (75.00%)  23 4/4 (100.00%)  8 13/14 (92.86%)  34
Edema limbs † 1  1/4 (25.00%)  1 1/12 (8.33%)  1 0/4 (0.00%)  0 4/14 (28.57%)  6
Fatigue † 1  2/4 (50.00%)  3 8/12 (66.67%)  11 4/4 (100.00%)  4 6/14 (42.86%)  7
Fever † 1  4/4 (100.00%)  14 12/12 (100.00%)  62 4/4 (100.00%)  14 13/14 (92.86%)  48
Flu like symptoms † 1  1/4 (25.00%)  2 3/12 (25.00%)  4 1/4 (25.00%)  1 6/14 (42.86%)  10
Gait disturbance † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Malaise † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1
Pain † 1  1/4 (25.00%)  1 3/12 (25.00%)  4 1/4 (25.00%)  1 1/14 (7.14%)  2
Hepatobiliary disorders         
Bile duct stenosis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  3
Hepatic pain † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Portal hypertension † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations         
Infections and infestations - Other, E/coli in stool † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Lung infection † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Upper respiratory infection † 1  0/4 (0.00%)  0 2/12 (16.67%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0
Urinary tract infection † 1  0/4 (0.00%)  0 2/12 (16.67%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0
Injury, poisoning and procedural complications         
Fall † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Investigations         
Activated partial thromboplastin time prolonged † 1  2/4 (50.00%)  3 7/12 (58.33%)  12 3/4 (75.00%)  7 3/14 (21.43%)  6
Alanine aminotransferase increased † 1  1/4 (25.00%)  5 5/12 (41.67%)  8 1/4 (25.00%)  2 5/14 (35.71%)  8
Alkaline phosphatase increased † 1  1/4 (25.00%)  2 6/12 (50.00%)  14 3/4 (75.00%)  4 7/14 (50.00%)  11
Aspartate aminotransferase increased † 1  1/4 (25.00%)  6 6/12 (50.00%)  9 3/4 (75.00%)  5 7/14 (50.00%)  16
Blood bilirubin increased † 1  1/4 (25.00%)  2 2/12 (16.67%)  5 1/4 (25.00%)  3 4/14 (28.57%)  13
Creatinine increased † 1  0/4 (0.00%)  0 4/12 (33.33%)  11 0/4 (0.00%)  0 3/14 (21.43%)  3
Lipase increased † 1  3/4 (75.00%)  3 2/12 (16.67%)  2 1/4 (25.00%)  1 3/14 (21.43%)  5
Lymphocyte count decreased † 1  4/4 (100.00%)  9 9/12 (75.00%)  30 4/4 (100.00%)  10 9/14 (64.29%)  26
Neutrophil count decreased † 1  0/4 (0.00%)  0 2/12 (16.67%)  3 0/4 (0.00%)  0 1/14 (7.14%)  1
Platelet count decreased † 1  3/4 (75.00%)  4 2/12 (16.67%)  8 1/4 (25.00%)  2 7/14 (50.00%)  9
Serum amylase increased † 1  0/4 (0.00%)  0 2/12 (16.67%)  4 2/4 (50.00%)  2 2/14 (14.29%)  5
Weight loss † 1  1/4 (25.00%)  1 2/12 (16.67%)  2 1/4 (25.00%)  1 0/14 (0.00%)  0
White blood cell decreased † 1  1/4 (25.00%)  1 1/12 (8.33%)  3 3/4 (75.00%)  4 4/14 (28.57%)  4
Metabolism and nutrition disorders         
Acidosis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Alkalosis † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Anorexia † 1  2/4 (50.00%)  4 3/12 (25.00%)  4 0/4 (0.00%)  0 3/14 (21.43%)  3
Dehydration † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  2 0/14 (0.00%)  0
Hypercalcemia † 1  0/4 (0.00%)  0 4/12 (33.33%)  6 1/4 (25.00%)  1 4/14 (28.57%)  5
Hyperglycemia † 1  1/4 (25.00%)  3 6/12 (50.00%)  13 0/4 (0.00%)  0 0/14 (0.00%)  0
Hyperkalemia † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Hypermagnesemia † 1  0/4 (0.00%)  0 2/12 (16.67%)  4 0/4 (0.00%)  0 2/14 (14.29%)  2
Hypernatremia † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Hyperuricemia † 1  1/4 (25.00%)  2 4/12 (33.33%)  10 0/4 (0.00%)  0 3/14 (21.43%)  3
Hypoalbuminemia † 1  2/4 (50.00%)  4 9/12 (75.00%)  20 3/4 (75.00%)  8 8/14 (57.14%)  20
Hypocalcemia † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 1/14 (7.14%)  1
Hypokalemia † 1  2/4 (50.00%)  2 2/12 (16.67%)  2 1/4 (25.00%)  2 4/14 (28.57%)  5
Hypomagnesemia † 1  0/4 (0.00%)  0 2/12 (16.67%)  3 2/4 (50.00%)  2 3/14 (21.43%)  4
Hyponatremia † 1  3/4 (75.00%)  3 7/12 (58.33%)  13 2/4 (50.00%)  3 6/14 (42.86%)  16
Hypophosphatemia † 1  2/4 (50.00%)  2 1/12 (8.33%)  3 3/4 (75.00%)  7 3/14 (21.43%)  4
Obesity † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Back pain † 1  2/4 (50.00%)  5 1/12 (8.33%)  1 1/4 (25.00%)  1 5/14 (35.71%)  8
Flank pain † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Generalized muscle weakness † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 3/14 (21.43%)  3
Musculoskeletal and connective tissue disorder - Other, Leg cramps † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Myalgia † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Non-cardiac chest pain † 1  0/4 (0.00%)  0 1/12 (8.33%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0
Pain in extremity † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 2/14 (14.29%)  2
Nervous system disorders         
Akathisia † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Dizziness † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 1/4 (25.00%)  1 3/14 (21.43%)  3
Headache † 1  1/4 (25.00%)  2 3/12 (25.00%)  7 0/4 (0.00%)  0 8/14 (57.14%)  11
Tremor † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Psychiatric disorders         
Agitation † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Anxiety † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1
Depression † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 1/4 (25.00%)  1 0/14 (0.00%)  0
Hallucinations † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Insomnia † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1
Psychiatric disorders - Other, Somnolent † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Renal and urinary disorders         
Urinary frequency † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Urinary tract obstruction † 1  1/4 (25.00%)  1 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Reproductive system and breast disorders         
Testicular pain † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis † 1  1/4 (25.00%)  1 2/12 (16.67%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0
Cough † 1  0/4 (0.00%)  0 3/12 (25.00%)  3 2/4 (50.00%)  2 2/14 (14.29%)  2
Dyspnea † 1  0/4 (0.00%)  0 3/12 (25.00%)  4 2/4 (50.00%)  2 3/14 (21.43%)  6
Hiccups † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Nasal congestion † 1  1/4 (25.00%)  1 3/12 (25.00%)  3 1/4 (25.00%)  1 2/14 (14.29%)  2
Pleural effusion † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Postnasal drip † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Productive cough † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, Mucous Plug † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Sore throat † 1  1/4 (25.00%)  1 1/12 (8.33%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders         
Dry skin † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 1/4 (25.00%)  1 0/14 (0.00%)  0
Hyperhidrosis † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 1/4 (25.00%)  1 0/14 (0.00%)  0
Papulopustular rash † 1  0/4 (0.00%)  0 5/12 (41.67%)  5 1/4 (25.00%)  1 4/14 (28.57%)  4
Pruritus † 1  1/4 (25.00%)  3 4/12 (33.33%)  4 3/4 (75.00%)  3 3/14 (21.43%)  3
Rash maculo-papular † 1  1/4 (25.00%)  1 4/12 (33.33%)  6 0/4 (0.00%)  0 0/14 (0.00%)  0
Rash pustular † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 1/4 (25.00%)  1 2/14 (14.29%)  2
Skin and subcutaneous tissue disorders - Other, Blister - toe † 1  0/4 (0.00%)  0 1/12 (8.33%)  0/4 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Cold sore- left lip † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Irritation † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Night Sweats † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders - Other, Sweating † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Swelling - leg † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Vesicle † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%) 
Skin and subcutaneous tissue disorders - Other, bump on clavicle † 1  1/4 (25.00%)  1 0/12 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, skin discoloration † 1  0/4 (0.00%)  0 1/12 (8.33%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0
Vascular disorders         
Hot flashes † 1  0/4 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1
Hypertension † 1  1/4 (25.00%)  1 2/12 (16.67%)  4 2/4 (50.00%)  5 1/14 (7.14%)  1
Hypotension † 1  2/4 (50.00%)  3 10/12 (83.33%)  23 1/4 (25.00%)  2 8/14 (57.14%)  15
1
Term from vocabulary, CTCAE (4.3)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tim F. Greten
Organization: National Cancer Institute
Phone: 240-760-6114
EMail: tim.greten@nih.gov
Publications:
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Responsible Party: Tim Greten, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03206073    
Other Study ID Numbers: 170092
17-C-0092
First Submitted: June 30, 2017
First Posted: July 2, 2017
Results First Submitted: August 30, 2021
Results First Posted: October 26, 2021
Last Update Posted: January 26, 2023