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Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy

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: NCT02731729
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : February 21, 2021
Last Update Posted : December 23, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Parker Institute for Cancer Immunotherapy

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: ipilimumab
Drug: nivolumab
Enrollment 20
Recruitment Details Participants were recruited at four institutions in the United States. Recruitment occurred between June 2016 to May 2018.
Pre-assignment Details 33 participants were assessed for eligibility. Out of the 33 participants, 20 patients met the inclusion/exclusion criteria and were randomized to the study arms.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Period Title: Overall Study
Started 10 10
Completed 1 2
Not Completed 9 8
Reason Not Completed
Death             2             2
Study terminated by Sponsor             6             6
Withdrawal by Subject             1             0
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab Total
Hide Arm/Group Description

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
Out of the 20 patients randomized, one participant randomized to the ipilimumab monotherapy arm withdrew consent before starting treatment. The remaining 19 patients were evaluated for efficacy and safety analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
66
(35 to 83)
56
(39 to 66)
60
(35 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
1
  10.0%
3
  33.3%
4
  21.1%
Male
9
  90.0%
6
  66.7%
15
  78.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Asian
1
  10.0%
0
   0.0%
1
   5.3%
White
7
  70.0%
9
 100.0%
16
  84.2%
Other
2
  20.0%
0
   0.0%
2
  10.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
ECOG Score = 0
7
  70.0%
6
  66.7%
13
  68.4%
ECOG Score = 1
3
  30.0%
3
  33.3%
6
  31.6%
[1]
Measure Description: The Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status is one such measurement. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The ECOG Performance Status ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
M stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
M0
1
  10.0%
3
  33.3%
4
  21.1%
M1a
2
  20.0%
1
  11.1%
3
  15.8%
M1b
3
  30.0%
2
  22.2%
5
  26.3%
M1c - without brain metastases
4
  40.0%
3
  33.3%
7
  36.8%
[1]
Measure Description:

The letter "M" indicates whether the cancer has spread to other parts of the body, called distant metastasis. If the cancer has not spread, it is labeled M0. If the cancer has spread, it is considered M1.

M1a: The cancer has spread to 1 other part of the body beyond the colon or rectum.

M1b: The cancer has spread to more than 1 part of the body other than the colon or rectum.

M1c: The cancer has spread to the peritoneal surface.

Type of Melanoma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Acral
1
  10.0%
1
  11.1%
2
  10.5%
Cutaneous
8
  80.0%
7
  77.8%
15
  78.9%
Mucosal
1
  10.0%
1
  11.1%
2
  10.5%
Genomic Driver  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
v-RAF murine sarcoma viral oncogene homolog B1 (BRAF)
3
  30.0%
2
  22.2%
5
  26.3%
Neuroblastoma RAS viral oncogene homolog (NRAS)
2
  20.0%
4
  44.4%
6
  31.6%
Other/Unknown
5
  50.0%
3
  33.3%
8
  42.1%
Prior Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Anti-PD-1
10
 100.0%
9
 100.0%
19
 100.0%
Other
3
  30.0%
1
  11.1%
4
  21.1%
Best response to prior anti-PD-1 treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Stable Disease
0
   0.0%
1
  11.1%
1
   5.3%
Progressive Disease
9
  90.0%
6
  66.7%
15
  78.9%
Unknown
1
  10.0%
2
  22.2%
3
  15.8%
Median lactate dehydrogenase  
Median (Full Range)
Unit of measure:  units/L
Number Analyzed 10 participants 9 participants 19 participants
214
(157 to 310)
208
(152 to 1800)
211
(152 to 1800)
Median time since last anti-PD-1 treatment  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 10 participants 9 participants 19 participants
4.3
(2 to 36)
6.0
(3 to 55)
5.1
(2 to 54.7)
1.Primary Outcome
Title Overall Response Rate (ORR) as Defined by RECIST v1.1 at Week 18
Hide Description Overall Response Rate was defined as any participant who had a Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1 by week 18 of treatment.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description:

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Overall Number of Participants Analyzed 10 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20
(3 to 56)
56
(21 to 86)
2.Secondary Outcome
Title Disease Control Rate (DCR) Status at Week 18
Hide Description Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 18.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description:

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Overall Number of Participants Analyzed 10 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60
(26 to 88)
67
(30 to 93)
3.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description Time to Treatment Failure is defined as the time from treatment initiation until the participant starts a subsequent therapy or death, whichever comes first.
Time Frame The time from treatment initiation until a subsequent therapy is started or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description:

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Overall Number of Participants Analyzed 10 9
Median (95% Confidence Interval)
Unit of Measure: months
26.9 [1] 
(0.7 to NA)
13.6 [1] 
(2.8 to NA)
[1]
The upper confidence limit is not evaluable based on the available data
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival is defined as the time of treatment initiation to death by any cause
Time Frame Death
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description:

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Overall Number of Participants Analyzed 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
1
  11.1%
5.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Adverse Events
Hide Description The occurrence of Grade 3 and Grade 4 adverse events (AE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame AE were monitored during each treatment cycle and could be reported until 30 days after the last dose of study treatment had been administered.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety-Evaluable Population. The safety-evaluable population includes all participants who received at least one dose of any study intervention. For analyses based on this population, participant treatment groups will be defined according to the treatment that was assigned at randomization. However, if a participant received the incorrect study drug for the entire period of treatment, the participant's treatment group will be defined as the treatment the participant actually received.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description:

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Overall Number of Participants Analyzed 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
4
  40.0%
5
  55.6%
6.Secondary Outcome
Title Disease Control Rate (DCR) Status at Week 12
Hide Description Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description:

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

Overall Number of Participants Analyzed 10 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.0
(26.2 to 87.8)
55.6
(21.2 to 86.3)
Time Frame Adverse events were monitored during each cycle. Adverse events were reported until 30 days after the last dose of study treatment had been administered.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ipilimumab and Nivolumab Ipilimumab
Hide Arm/Group Description

For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.

ipilimumab

nivolumab

In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

ipilimumab

All-Cause Mortality
Ipilimumab and Nivolumab Ipilimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   1/9 (11.11%) 
Hide Serious Adverse Events
Ipilimumab and Nivolumab Ipilimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   4/9 (44.44%) 
Cardiac disorders     
Pericardial effusion  1  1/10 (10.00%)  0/9 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  0/10 (0.00%)  1/9 (11.11%) 
Gastrointestinal disorders     
Colitis  1  0/10 (0.00%)  2/9 (22.22%) 
Diarrhoea  1  1/10 (10.00%)  1/9 (11.11%) 
Abdominal pain  1  0/10 (0.00%)  1/9 (11.11%) 
Vomiting  1  1/10 (10.00%)  0/9 (0.00%) 
Nausea  1  1/10 (10.00%)  1/9 (11.11%) 
Infections and infestations     
Urinary tract infection  1  0/10 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications     
Hip fracture  1  0/10 (0.00%)  1/9 (11.11%) 
Investigations     
Neutrophil count decreased  1  0/10 (0.00%)  1/9 (11.11%) 
White blood cell count decreased  1  0/10 (0.00%)  1/9 (11.11%) 
Nervous system disorders     
Headache  1  0/10 (0.00%)  1/9 (11.11%) 
Psychiatric disorders     
Confusional state  1  0/10 (0.00%)  2/9 (22.22%) 
Reproductive system and breast disorders     
Pleural effusion  1  1/10 (10.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/10 (10.00%)  0/9 (0.00%) 
Vascular disorders     
Hypertension  1  0/10 (0.00%)  1/9 (11.11%) 
Hypotension  1  1/10 (10.00%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ipilimumab and Nivolumab Ipilimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   9/9 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/10 (10.00%)  1/9 (11.11%) 
Cardiac disorders     
Bundle branch block left  1  0/10 (0.00%)  1/9 (11.11%) 
Sinus bradycardia  1  0/10 (0.00%)  1/9 (11.11%) 
Sinus tachycardia  1  0/10 (0.00%)  1/9 (11.11%) 
Ventricular tachycardia  1  1/10 (10.00%)  0/9 (0.00%) 
Endocrine disorders     
Hypophysitis  1  3/10 (30.00%)  1/9 (11.11%) 
Hypothyroidism  1  1/10 (10.00%)  1/9 (11.11%) 
Hyperthyroidism  1  1/10 (10.00%)  0/9 (0.00%) 
Eye disorders     
Vision blurred  1  1/10 (10.00%)  0/9 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  5/10 (50.00%)  4/9 (44.44%) 
Abdominal pain  1  2/10 (20.00%)  4/9 (44.44%) 
Nausea  1  5/10 (50.00%)  0/9 (0.00%) 
Constipation  1  2/10 (20.00%)  1/9 (11.11%) 
Dry mouth  1  1/10 (10.00%)  2/9 (22.22%) 
Vomiting  1  1/10 (10.00%)  1/9 (11.11%) 
Abdominal distension  1  1/10 (10.00%)  0/9 (0.00%) 
Abdominal pain upper  1  0/10 (0.00%)  1/9 (11.11%) 
Colitis  1  1/10 (10.00%)  0/9 (0.00%) 
Faecaloma  1  0/10 (0.00%)  1/9 (11.11%) 
Flatulence  1  0/10 (0.00%)  1/9 (11.11%) 
Gastrooesophageal reflux disease  1  0/10 (0.00%)  1/9 (11.11%) 
Haemorrhoids  1  1/10 (10.00%)  0/9 (0.00%) 
General disorders     
Pyrexia  1  3/10 (30.00%)  3/9 (33.33%) 
Fatigue  1  2/10 (20.00%)  3/9 (33.33%) 
Chills  1  0/10 (0.00%)  2/9 (22.22%) 
Oedema peripheral  1  1/10 (10.00%)  1/9 (11.11%) 
Influenza like illness  1  0/10 (0.00%)  1/9 (11.11%) 
Hepatobiliary disorders     
Biliary colic  1  0/10 (0.00%)  1/9 (11.11%) 
Cholelithiasis  1  0/10 (0.00%)  1/9 (11.11%) 
Infections and infestations     
Skin infection  1  1/10 (10.00%)  1/9 (11.11%) 
Lung infection  1  1/10 (10.00%)  0/9 (0.00%) 
Oral herpes  1  1/10 (10.00%)  0/9 (0.00%) 
Proteus infection  1  1/10 (10.00%)  0/9 (0.00%) 
Sinusitis  1  0/10 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications     
Post procedural swelling  1  1/10 (10.00%)  0/9 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  5/10 (50.00%)  2/9 (22.22%) 
Aspartate aminotransferase increased  1  4/10 (40.00%)  1/9 (11.11%) 
White blood cell count decreased  1  2/10 (20.00%)  2/9 (22.22%) 
Platelet count decreased  1  2/10 (20.00%)  1/9 (11.11%) 
Weight decreased  1  1/10 (10.00%)  2/9 (22.22%) 
Neutrophil count decreased  1  1/10 (10.00%)  1/9 (11.11%) 
Amylase increased  1  0/10 (0.00%)  1/9 (11.11%) 
Blood alkaline phosphatase increased  1  0/10 (0.00%)  1/9 (11.11%) 
Blood bilirubin increased  1  1/10 (10.00%)  0/9 (0.00%) 
Lipase increased  1  0/10 (0.00%)  1/9 (11.11%) 
Lymphocyte count decreased  1  0/10 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders     
Hypoalbuminaemia  1  3/10 (30.00%)  5/9 (55.56%) 
Hyponatraemia  1  2/10 (20.00%)  2/9 (22.22%) 
Decreased appetite  1  1/10 (10.00%)  2/9 (22.22%) 
Hypokalaemia  1  1/10 (10.00%)  2/9 (22.22%) 
Hypocalcaemia  1  0/10 (0.00%)  2/9 (22.22%) 
Hypercalcaemia  1  0/10 (0.00%)  1/9 (11.11%) 
Hyperglycaemia  1  0/10 (0.00%)  1/9 (11.11%) 
Hyperkalaemia  1  0/10 (0.00%)  1/9 (11.11%) 
Hypernatraemia  1  1/10 (10.00%)  0/9 (0.00%) 
Hypoglycaemia  1  1/10 (10.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/10 (10.00%)  2/9 (22.22%) 
Pain in extremity  1  0/10 (0.00%)  2/9 (22.22%) 
Back pain  1  0/10 (0.00%)  1/9 (11.11%) 
Myalgia  1  0/10 (0.00%)  1/9 (11.11%) 
Nervous system disorders     
Headache  1  3/10 (30.00%)  1/9 (11.11%) 
Hypoaesthesia  1  1/10 (10.00%)  0/9 (0.00%) 
Peripheral sensory neuropathy  1  1/10 (10.00%)  0/9 (0.00%) 
Syncope  1  0/10 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders     
Pollakiuria  1  0/10 (0.00%)  1/9 (11.11%) 
Reproductive system and breast disorders     
Pelvic pain  1  0/10 (0.00%)  1/9 (11.11%) 
Vulval disorder  1  0/10 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/10 (40.00%)  2/9 (22.22%) 
Nasal congestion  1  2/10 (20.00%)  2/9 (22.22%) 
Dysphonia  1  1/10 (10.00%)  0/9 (0.00%) 
Oropharyngeal pain  1  1/10 (10.00%)  0/9 (0.00%) 
Rhonchi  1  0/10 (0.00%)  1/9 (11.11%) 
Upper-airway cough syndrome  1  0/10 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  7/10 (70.00%)  5/9 (55.56%) 
Rash maculo-papular  1  5/10 (50.00%)  3/9 (33.33%) 
Dry skin  1  0/10 (0.00%)  1/9 (11.11%) 
Erythema multiforme  1  1/10 (10.00%)  0/9 (0.00%) 
Hair color changes  1  0/10 (0.00%)  1/9 (11.11%) 
Lichenoid keratosis  1  1/10 (10.00%)  0/9 (0.00%) 
Skin hypopigmentation  1  1/10 (10.00%)  0/9 (0.00%) 
Stasis dermatitis  1  0/10 (0.00%)  1/9 (11.11%) 
Vascular disorders     
Hypertension  1  4/10 (40.00%)  4/9 (44.44%) 
Hypotension  1  1/10 (10.00%)  0/9 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Trial Site and/or Co-Principal Investigators may publish or present Study Data and other results of the Study from the Trial Site individually upon the first to occur of: (i) twelve (12) months after conclusion, abandonment, or termination of the Study at all Affiliated Research Institutions, or (ii) after Parker Institute for Cancer Immunotherapy [PICI] confirms in writing there will not be a multi-site Study publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ute Dugan
Organization: Parker Institute for Cancer Immunotherapy
Phone: 203-379-6757
EMail: udugan@parkerici.org
Layout table for additonal information
Responsible Party: Parker Institute for Cancer Immunotherapy
ClinicalTrials.gov Identifier: NCT02731729    
Other Study ID Numbers: PICI0001
16-043 ( Other Identifier: Memorial Sloan Kettering Cancer Center )
First Submitted: April 4, 2016
First Posted: April 7, 2016
Results First Submitted: January 12, 2021
Results First Posted: February 21, 2021
Last Update Posted: December 23, 2022