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Trial record 1 of 1 for:    checkmate 069
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Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma (CheckMate 069)

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: NCT01927419
Recruitment Status : Active, not recruiting
First Posted : August 22, 2013
Results First Posted : February 8, 2016
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Unresectable Melanoma
Metastatic Melanoma
Interventions Drug: Nivolumab
Drug: Ipilimumab
Drug: Placebo
Enrollment 179
Recruitment Details  
Pre-assignment Details Of 179 participants enrolled, 142 (95 in the nivolumab + ipilimumab group and 47 in the ipilimumab group) were randomized, and 140 (94 in the nivolumab + ipilimumab group and 46 in the ipilimumab group) received treatment.
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Period Title: Overall Study
Started 95 47
Received Treatment 94 46
Completed 25 [1] 19 [1]
Not Completed 70 28
Reason Not Completed
Disease progression             15             17
Study drug toxicity             43             7
Death             0             1
Adverse event unrelated to study drug             6             1
Withdrawal by Subject             3             1
Other             2             1
Not reported             1             0
[1]
All participants who did not discontinue study drug during treatment period (Parts 1 and 2)
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab Total
Hide Arm/Group Description Participants received (Part) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. Total of all reporting groups
Overall Number of Baseline Participants 95 47 142
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 47 participants 142 participants
63.3  (11.02) 64.5  (10.24) 63.7  (10.74)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
Younger than 65 years 48 20 68
65 years and older to younger than 75 years 35 22 57
75 years and older 12 5 17
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
Female
32
  33.7%
15
  31.9%
47
  33.1%
Male
63
  66.3%
32
  68.1%
95
  66.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
White 92 47 139
Asian 1 0 1
Other 2 0 2
Black or African American 0 0 0
American Indian or Alaska Native 0 0 0
Native Hawaiian or other Pacific Islander 0 0 0
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 95 participants 47 participants 142 participants
86.26  (23.368) 83.29  (20.248) 85.28  (22.355)
Time from initial diagnosis  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 95 participants 47 participants 142 participants
2.34
(0.1 to 47.4)
1.71
(0.1 to 20.4)
2.01
(0.1 to 47.4)
Time from initial diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
Less than 1 year 28 18 46
1 to less than 2 years 16 9 25
2 to less than 3 years 17 3 20
3 to less than 4 years 4 1 5
4 to less than 5 years 4 5 9
5 years or more 26 11 37
Baseline lactate dehydrogenase level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
Upper limit of normal (ULN) or lower 70 36 106
Higher than ULN 24 11 35
2*ULN or lower 88 46 134
Higher than 2*ULN 6 1 7
Not reported 1 0 1
History of brain metastases  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
Yes 4 0 4
No 90 47 137
Not reported 1 0 1
Smoking status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
Yes 39 24 63
No 55 22 77
Unknown 1 1 2
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 47 participants 142 participants
0 79 37 116
1 14 10 24
2 2 0 2
[1]
Measure Description: ECOG is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
1.Primary Outcome
Title Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population
Hide Description Objective Response Rate is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized BRAF wild-type patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Randomization to a minimum of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized BRAF wild-type participants .
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description:
Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Overall Number of Participants Analyzed 72 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
59.7
(47.5 to 71.1)
10.8
(3.0 to 25.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nivolumab + Ipilimumab, Placebo + Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.23
Confidence Interval (2-Sided) 95%
3.69 to 51.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population
Hide Description Objective Response Rate is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Randomization to a minimum of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description:
Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Overall Number of Participants Analyzed 95 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
55.8
(45.2 to 66.0)
8.5
(2.4 to 20.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nivolumab + Ipilimumab, Placebo + Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.08
Confidence Interval (2-Sided) 95%
4.85 to 46.93
Estimation Comments All randomized participants
3.Secondary Outcome
Title Investigator-assessed Progression-free Survival (PFS) in All Populations
Hide Description PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first. WT=wild type
Time Frame Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description:
Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Overall Number of Participants Analyzed 95 47
Median (95% Confidence Interval)
Unit of Measure: Months
All randomized participants
8.57 [1] 
(7.03 to NA)
3.73
(2.76 to 5.13)
All BRAF WT participants (n=72, 37)
8.87 [1] 
(7.03 to NA)
4.73
(2.76 to 5.32)
[1]
Participants have not been followed-up long enough in the current database to estimate the upper limit of the confidence interval for median PFS.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nivolumab + Ipilimumab, Placebo + Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.23 to 0.63
Estimation Comments All randomized participants
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nivolumab + Ipilimumab, Placebo + Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0012
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.22 to 0.71
Estimation Comments All randomized BRAF WT participants
4.Secondary Outcome
Title Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response
Hide Description Objective Response is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR); percentage is determined by that total divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Randomization to a minimum of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All BRAF mutation-positive participants
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description:
Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Overall Number of Participants Analyzed 23 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
43.5
(23.2 to 65.5)
0
(0.0 to 30.8)
5.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score
Hide Description Health-related QOL was measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/quality of life composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 questionnaire, Version 3. The EORTC QLQ-C30 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool covering multiple items, including 5 functional scales (physical, role, emotional, social, and cognitive); 3 symptom scales (fatigue, nausea and vomiting, and pain); a global health status/QOL scale; and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each item range from 0 to 100. A high score for a functional scale represents a high (healthy) level of functioning, and a high score for the global health status represents a high QOL. However, a high score for a symptom scale represents more severe symptoms.
Time Frame From Baseline to Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. n=number of participants evaluable
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description:
Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) until documented disease progression, toxicity, withdrawal of consent, or study completion.
Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Overall Number of Participants Analyzed 95 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 7 (n=55, 37) -6.67  (23.701) -6.31  (19.485)
Week 13 (n=31, 21) -1.61  (21.237) -9.13  (25.672)
Week 19 (n=29, 14) -3.16  (20.704) -6.55  (34.309)
Week 25 (n=22,13) 3.79  (11.422) -0.64  (29.357)
6.Other Pre-specified Outcome
Title Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Time Frame Day 1 of treatment to within 30 days past last dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description:
Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Overall Number of Participants Analyzed 94 46
Measure Type: Number
Unit of Measure: Participants
Deaths 5 2
SAEs 58 18
AEs leading to discontinuation 40 5
Select AEs: Skin 73 29
Select AEs: Gastrointestinal 51 20
Select AEs: Endocrine 31 7
Select AEs: Hepatic 30 3
Select AEs: Pulmonary 9 1
Select AEs: Renal 9 2
Select AEs: Hypersensitivity/IRs 3 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nivolumab + Ipilimumab Placebo + Ipilimumab
Hide Arm/Group Description Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
All-Cause Mortality
Nivolumab + Ipilimumab Placebo + Ipilimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nivolumab + Ipilimumab Placebo + Ipilimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   58/94 (61.70%)   18/46 (39.13%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/94 (1.06%)  0/46 (0.00%) 
Haemolysis  1  1/94 (1.06%)  0/46 (0.00%) 
Thrombocytopenia  1  1/94 (1.06%)  0/46 (0.00%) 
Cardiac disorders     
Ventricular arrhythmia  1  1/94 (1.06%)  0/46 (0.00%) 
Atrial fibrillation  1  1/94 (1.06%)  1/46 (2.17%) 
Endocrine disorders     
Adrenal insufficiency  1  2/94 (2.13%)  0/46 (0.00%) 
Autoimmune thyroiditis  1  1/94 (1.06%)  0/46 (0.00%) 
Hypophysitis  1  2/94 (2.13%)  1/46 (2.17%) 
Gastrointestinal disorders     
Abdominal pain lower  1  0/94 (0.00%)  1/46 (2.17%) 
Oesophageal pain  1  1/94 (1.06%)  0/46 (0.00%) 
Small intestinal obstruction  1  1/94 (1.06%)  0/46 (0.00%) 
Abdominal pain  1  1/94 (1.06%)  0/46 (0.00%) 
Constipation  1  2/94 (2.13%)  0/46 (0.00%) 
Enterocolitis  1  1/94 (1.06%)  0/46 (0.00%) 
Pancreatitis  1  2/94 (2.13%)  0/46 (0.00%) 
Vomiting  1  2/94 (2.13%)  1/46 (2.17%) 
Diarrhoea  1  8/94 (8.51%)  3/46 (6.52%) 
Large intestine perforation  1  1/94 (1.06%)  0/46 (0.00%) 
Ascites  1  1/94 (1.06%)  0/46 (0.00%) 
Colitis  1  16/94 (17.02%)  4/46 (8.70%) 
Diarrhoea haemorrhagic  1  1/94 (1.06%)  0/46 (0.00%) 
General disorders     
Chills  1  0/94 (0.00%)  1/46 (2.17%) 
Chest pain  1  2/94 (2.13%)  1/46 (2.17%) 
Pyrexia  1  6/94 (6.38%)  3/46 (6.52%) 
General physical health deterioration  1  2/94 (2.13%)  0/46 (0.00%) 
Hepatobiliary disorders     
Hepatocellular injury  1  1/94 (1.06%)  0/46 (0.00%) 
Hepatitis  1  2/94 (2.13%)  0/46 (0.00%) 
Infections and infestations     
Enterococcal bacteraemia  1  1/94 (1.06%)  0/46 (0.00%) 
Septic shock  1  1/94 (1.06%)  0/46 (0.00%) 
Periorbital cellulitis  1  1/94 (1.06%)  0/46 (0.00%) 
Sepsis  1  1/94 (1.06%)  0/46 (0.00%) 
Diverticulitis  1  1/94 (1.06%)  0/46 (0.00%) 
Epididymitis  1  1/94 (1.06%)  0/46 (0.00%) 
Abscess  1  1/94 (1.06%)  0/46 (0.00%) 
Pneumonia  1  3/94 (3.19%)  1/46 (2.17%) 
Investigations     
Transaminases increased  1  1/94 (1.06%)  0/46 (0.00%) 
Liver function test abnormal  1  1/94 (1.06%)  0/46 (0.00%) 
Alanine aminotransferase increased  1  1/94 (1.06%)  0/46 (0.00%) 
Troponin I increased  1  1/94 (1.06%)  0/46 (0.00%) 
Blood creatinine increased  1  1/94 (1.06%)  0/46 (0.00%) 
Amylase increased  1  1/94 (1.06%)  0/46 (0.00%) 
Lipase increased  1  1/94 (1.06%)  0/46 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia  1  1/94 (1.06%)  0/46 (0.00%) 
Diabetic ketoacidosis  1  1/94 (1.06%)  0/46 (0.00%) 
Hyperkalaemia  1  0/94 (0.00%)  1/46 (2.17%) 
Dehydration  1  2/94 (2.13%)  0/46 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/94 (0.00%)  1/46 (2.17%) 
Arthralgia  1  0/94 (0.00%)  1/46 (2.17%) 
Back pain  1  0/94 (0.00%)  1/46 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  1/94 (1.06%)  2/46 (4.35%) 
Squamous cell carcinoma  1  0/94 (0.00%)  1/46 (2.17%) 
Nervous system disorders     
Guillain-Barre syndrome  1  1/94 (1.06%)  0/46 (0.00%) 
Syncope  1  0/94 (0.00%)  1/46 (2.17%) 
Embolic stroke  1  1/94 (1.06%)  0/46 (0.00%) 
Spinal cord compression  1  0/94 (0.00%)  1/46 (2.17%) 
Convulsion  1  0/94 (0.00%)  1/46 (2.17%) 
Neuralgia  1  1/94 (1.06%)  0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleuritic pain  1  1/94 (1.06%)  0/46 (0.00%) 
Hypoxia  1  0/94 (0.00%)  2/46 (4.35%) 
Pulmonary embolism  1  1/94 (1.06%)  0/46 (0.00%) 
Dyspnoea  1  2/94 (2.13%)  0/46 (0.00%) 
Pleural effusion  1  1/94 (1.06%)  1/46 (2.17%) 
Pneumonitis  1  5/94 (5.32%)  0/46 (0.00%) 
Bronchial obstruction  1  0/94 (0.00%)  1/46 (2.17%) 
Vascular disorders     
Hypotension  1  1/94 (1.06%)  1/46 (2.17%) 
Deep vein thrombosis  1  2/94 (2.13%)  0/46 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nivolumab + Ipilimumab Placebo + Ipilimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   88/94 (93.62%)   43/46 (93.48%) 
Blood and lymphatic system disorders     
Anaemia  1  16/94 (17.02%)  6/46 (13.04%) 
Endocrine disorders     
Adrenal insufficiency  1  2/94 (2.13%)  3/46 (6.52%) 
Hypothyroidism  1  13/94 (13.83%)  4/46 (8.70%) 
Hypophysitis  1  12/94 (12.77%)  2/46 (4.35%) 
Eye disorders     
Eye pain  1  6/94 (6.38%)  2/46 (4.35%) 
Vision blurred  1  11/94 (11.70%)  0/46 (0.00%) 
Gastrointestinal disorders     
Flatulence  1  3/94 (3.19%)  3/46 (6.52%) 
Rectal haemorrhage  1  1/94 (1.06%)  3/46 (6.52%) 
Abdominal pain upper  1  3/94 (3.19%)  3/46 (6.52%) 
Dyspepsia  1  5/94 (5.32%)  2/46 (4.35%) 
Abdominal pain  1  11/94 (11.70%)  8/46 (17.39%) 
Constipation  1  22/94 (23.40%)  13/46 (28.26%) 
Nausea  1  32/94 (34.04%)  20/46 (43.48%) 
Vomiting  1  21/94 (22.34%)  6/46 (13.04%) 
Diarrhoea  1  42/94 (44.68%)  19/46 (41.30%) 
Colitis  1  7/94 (7.45%)  2/46 (4.35%) 
Abdominal discomfort  1  2/94 (2.13%)  3/46 (6.52%) 
Abdominal distension  1  6/94 (6.38%)  2/46 (4.35%) 
Dry mouth  1  6/94 (6.38%)  4/46 (8.70%) 
General disorders     
Oedema peripheral  1  15/94 (15.96%)  5/46 (10.87%) 
Chills  1  13/94 (13.83%)  3/46 (6.52%) 
Asthenia  1  12/94 (12.77%)  5/46 (10.87%) 
Chest pain  1  3/94 (3.19%)  3/46 (6.52%) 
Pain  1  13/94 (13.83%)  6/46 (13.04%) 
Pyrexia  1  22/94 (23.40%)  11/46 (23.91%) 
Fatigue  1  49/94 (52.13%)  30/46 (65.22%) 
Mucosal inflammation  1  2/94 (2.13%)  3/46 (6.52%) 
Infections and infestations     
Upper respiratory tract infection  1  2/94 (2.13%)  3/46 (6.52%) 
Urinary tract infection  1  5/94 (5.32%)  2/46 (4.35%) 
Investigations     
Alanine aminotransferase increased  1  23/94 (24.47%)  3/46 (6.52%) 
Blood alkaline phosphatase increased  1  8/94 (8.51%)  1/46 (2.17%) 
Blood creatinine increased  1  7/94 (7.45%)  1/46 (2.17%) 
Aspartate aminotransferase increased  1  26/94 (27.66%)  3/46 (6.52%) 
Blood thyroid stimulating hormone increased  1  6/94 (6.38%)  0/46 (0.00%) 
Amylase increased  1  8/94 (8.51%)  1/46 (2.17%) 
Lipase increased  1  11/94 (11.70%)  4/46 (8.70%) 
Blood thyroid stimulating hormone decreased  1  6/94 (6.38%)  1/46 (2.17%) 
Weight increased  1  1/94 (1.06%)  3/46 (6.52%) 
Weight decreased  1  11/94 (11.70%)  0/46 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  11/94 (11.70%)  1/46 (2.17%) 
Hypoalbuminaemia  1  8/94 (8.51%)  2/46 (4.35%) 
Hyperglycaemia  1  6/94 (6.38%)  1/46 (2.17%) 
Decreased appetite  1  18/94 (19.15%)  13/46 (28.26%) 
Hypokalaemia  1  8/94 (8.51%)  2/46 (4.35%) 
Dehydration  1  14/94 (14.89%)  3/46 (6.52%) 
Hypomagnesaemia  1  7/94 (7.45%)  2/46 (4.35%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  8/94 (8.51%)  8/46 (17.39%) 
Musculoskeletal pain  1  6/94 (6.38%)  2/46 (4.35%) 
Arthralgia  1  13/94 (13.83%)  9/46 (19.57%) 
Muscular weakness  1  7/94 (7.45%)  1/46 (2.17%) 
Back pain  1  8/94 (8.51%)  4/46 (8.70%) 
Pain in extremity  1  5/94 (5.32%)  4/46 (8.70%) 
Nervous system disorders     
Dizziness  1  9/94 (9.57%)  4/46 (8.70%) 
Dysgeusia  1  6/94 (6.38%)  1/46 (2.17%) 
Headache  1  23/94 (24.47%)  9/46 (19.57%) 
Paraesthesia  1  5/94 (5.32%)  0/46 (0.00%) 
Neuropathy peripheral  1  4/94 (4.26%)  3/46 (6.52%) 
Psychiatric disorders     
Insomnia  1  16/94 (17.02%)  8/46 (17.39%) 
Depression  1  2/94 (2.13%)  3/46 (6.52%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  3/94 (3.19%)  4/46 (8.70%) 
Nasal congestion  1  4/94 (4.26%)  3/46 (6.52%) 
Dysphonia  1  3/94 (3.19%)  3/46 (6.52%) 
Dyspnoea  1  18/94 (19.15%)  9/46 (19.57%) 
Cough  1  21/94 (22.34%)  14/46 (30.43%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  5/94 (5.32%)  1/46 (2.17%) 
Rash maculo-papular  1  15/94 (15.96%)  6/46 (13.04%) 
Dry skin  1  5/94 (5.32%)  3/46 (6.52%) 
Rash  1  40/94 (42.55%)  14/46 (30.43%) 
Rash erythematous  1  1/94 (1.06%)  4/46 (8.70%) 
Erythema  1  8/94 (8.51%)  1/46 (2.17%) 
Rash pruritic  1  3/94 (3.19%)  5/46 (10.87%) 
Vitiligo  1  11/94 (11.70%)  3/46 (6.52%) 
Pruritus  1  35/94 (37.23%)  12/46 (26.09%) 
Vascular disorders     
Hypotension  1  4/94 (4.26%)  3/46 (6.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01927419    
Other Study ID Numbers: CA209-069
2013-002018-11 ( EudraCT Number )
First Submitted: August 20, 2013
First Posted: August 22, 2013
Results First Submitted: November 3, 2015
Results First Posted: February 8, 2016
Last Update Posted: June 1, 2020