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An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself (CheckMate204)

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ClinicalTrials.gov Identifier: NCT02320058
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : October 5, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: Ipilimumab
Drug: Nivolumab
Enrollment 119
Recruitment Details  
Pre-assignment Details 119 participants treated
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity. Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Period Title: Overall Study
Started 101 18
Completed 59 5
Not Completed 42 13
Reason Not Completed
Death             25             10
Lost to Follow-up             4             0
Other reasons             4             1
Withdrawal by Subject             8             2
Not reported             1             0
Arm/Group Title Cohort A Cohort B Total
Hide Arm/Group Description Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity. Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 101 18 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 18 participants 119 participants
58.0  (12.29) 58.2  (13.24) 58.0  (12.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 18 participants 119 participants
Female
33
  32.7%
5
  27.8%
38
  31.9%
Male
68
  67.3%
13
  72.2%
81
  68.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 18 participants 119 participants
Hispanic or Latino
2
   2.0%
3
  16.7%
5
   4.2%
Not Hispanic or Latino
99
  98.0%
15
  83.3%
114
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 101 participants 18 participants 119 participants
White 99 17 116
Black or African American 0 0 0
Asian 1 0 1
American Indian or Alaska Native 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Other 1 1 2
1.Primary Outcome
Title Intracranial Clinical Benefit Rate (CBR)
Hide Description Intracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of >6 months, as determined by modified RECIST 1.1 criteria for index intracranial lesions based on investigator review.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
57.4
(47.2 to 67.2)
16.7
(3.6 to 41.4)
2.Secondary Outcome
Title Intracranial Objective Response Rate (ORR)
Hide Description Investigator-Assessed Intracranial Objective Response Rate (ORR) per modified RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
53.5
(43.3 to 63.5)
16.7
(3.6 to 41.4)
3.Secondary Outcome
Title Intracranial Progression Free Survival (PFS)
Hide Description Intracranial progression-free survival (PFS) per modified RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(6.87 to NA)
1.18
(0.72 to 1.25)
[1]
Median and Upper Limit not reached per the Kaplan-Meier method, as the probability of survival was still above 50%
4.Secondary Outcome
Title Extracranial Clinical Benefit Rate (CBR)
Hide Description Extracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of >6 months, as determined by RECIST 1.1 criteria for index extracranial lesions based on investigator review.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
53.5
(43.3 to 63.5)
22.2
(6.4 to 47.6)
5.Secondary Outcome
Title Extracranial Objective Response Rate (ORR)
Hide Description Extracranial Objective Response Rate (ORR) per RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
48.5
(38.4 to 58.7)
22.2
(6.4 to 47.6)
6.Secondary Outcome
Title Extracranial Progression Free Survival (PFS)
Hide Description Extracranial progression-free survival (PFS) per RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Median (95% Confidence Interval)
Unit of Measure: Months
39.29
(16.13 to 45.80)
1.77 [1] 
(0.79 to NA)
[1]
upper limit of the confidence interval is not yet reached
7.Secondary Outcome
Title Global Clinical Benefit Rate (CBR)
Hide Description Investigator-assessed global (intracranial + extracranial) clinical benefit rate (CBR) per a combination of modified RECIST 1.1 criteria for intracranial lesions and RECIST 1.1 for extracranial disease is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of >6 months
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
55.4
(45.2 to 65.3)
22.2
(6.4 to 47.6)
8.Secondary Outcome
Title Global Objective Response Rate (ORR)
Hide Description Investigator-assessed global objective response rate (ORR) per a combination of modified RECIST 1.1 criteria for intracranial lesions and RECIST 1.1 for extracranial disease is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
51.5
(41.3 to 61.6)
22.2
(6.4 to 47.6)
9.Secondary Outcome
Title Global Progression Free Survival (PFS)
Hide Description Investigator-assessed global progression free survival (PFS) per a combination of modified RECIST 1.1 criteria for intracranial lesions and RECIST 1.1 for extracranial disease is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Median (95% Confidence Interval)
Unit of Measure: Months
29.54 [1] 
(6.87 to NA)
1.18
(0.79 to 4.14)
[1]
upper limit of the confidence interval is not yet reached
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) is defined as the time from the date of the start of treatment until the date of death. For participants who have not died, OS will be censored at the recorded last date of participant contact, and participants with a missing recorded last date of contact will be censored at the last date the participant was known to be alive.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Median (95% Confidence Interval)
Unit of Measure: Months
45.80 [1] 
(45.80 to NA)
8.77 [1] 
(1.77 to NA)
[1]
upper limit of the confidence interval is not yet reached
11.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Number of participants with any grade of adverse events (AEs) and any grade of serious adverse events (SAEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Time Frame From first dose to 30 days post last dose (Up to 66 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Events (AEs)
98
  97.0%
18
 100.0%
Serious Adverse Events (SAEs)
44
  43.6%
11
  61.1%
12.Secondary Outcome
Title Number of Participants Deaths
Hide Description Number of participants who died due to any cause.
Time Frame Up to 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Count of Participants
Unit of Measure: Participants
29
  28.7%
10
  55.6%
13.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Hide Description

Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

  • ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
  • Total bilirubin > 2 x ULN
  • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
  • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Time Frame From first dose to 30 days post last dose (Up to 66 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 96 15
Measure Type: Count of Participants
Unit of Measure: Participants
ALT OR AST > 3XULN
25
  26.0%
1
   6.7%
ALT OR AST > 5XULN
16
  16.7%
0
   0.0%
ALT OR AST > 10XULN
7
   7.3%
0
   0.0%
ALT OR AST > 20XULN
2
   2.1%
0
   0.0%
TOTAL BILIRUBIN > 2XULN
3
   3.1%
0
   0.0%
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY
1
   1.0%
0
   0.0%
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS
1
   1.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Hide Description

Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized:

  • TSH value > ULN and
  • with baseline TSH value <= ULN
  • with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
  • with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
  • with FT3/FT4 missing within 2-week window after the abnormal TSH test.
  • TSH < LLN and
  • with baseline TSH value >= LLN
  • with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
  • with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
  • with FT3/FT4 missing within 2-week window after the abnormal TSH test
Time Frame From first dose to 30 days post last dose (Up to 66 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with at least one on-treatment TSH measurement
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 101 18
Measure Type: Count of Participants
Unit of Measure: Participants
TSH > ULN
33
  32.7%
2
  11.1%
TSH > ULN WITH TSH <= ULN AT BASELINE
26
  25.7%
2
  11.1%
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
10
   9.9%
0
   0.0%
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
4
   4.0%
0
   0.0%
TSH > ULN WITH FT3/FT4 TEST MISSING
23
  22.8%
0
   0.0%
TSH < LLN
38
  37.6%
5
  27.8%
TSH < LLN WITH TSH >= LLN AT BASELINE
37
  36.6%
4
  22.2%
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
7
   6.9%
0
   0.0%
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
2
   2.0%
1
   5.6%
TSH < LLN WITH FT3/FT4 TEST MISSING
15
  14.9%
2
  11.1%
Time Frame From first dose to 100 days post last dose (Up to 68 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity. Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
All-Cause Mortality
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   29/101 (28.71%)   10/18 (55.56%) 
Hide Serious Adverse Events
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   50/101 (49.50%)   14/18 (77.78%) 
Blood and lymphatic system disorders     
WARM TYPE HAEMOLYTIC ANAEMIA † 1  1/101 (0.99%)  0/18 (0.00%) 
Cardiac disorders     
ACUTE CORONARY SYNDROME † 1  2/101 (1.98%)  0/18 (0.00%) 
ANGINA PECTORIS † 1  1/101 (0.99%)  0/18 (0.00%) 
ATRIAL FIBRILLATION † 1  3/101 (2.97%)  0/18 (0.00%) 
MYOCARDITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
Endocrine disorders     
ADRENAL INSUFFICIENCY † 1  4/101 (3.96%)  0/18 (0.00%) 
HYPERTHYROIDISM † 1  3/101 (2.97%)  0/18 (0.00%) 
HYPOPHYSITIS † 1  6/101 (5.94%)  0/18 (0.00%) 
Eye disorders     
VISION BLURRED † 1  2/101 (1.98%)  0/18 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN † 1  1/101 (0.99%)  0/18 (0.00%) 
COLITIS † 1  5/101 (4.95%)  1/18 (5.56%) 
DIARRHOEA † 1  6/101 (5.94%)  1/18 (5.56%) 
DUODENITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
GASTRITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE † 1  1/101 (0.99%)  0/18 (0.00%) 
IMMUNE-MEDIATED PANCREATITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
NAUSEA † 1  3/101 (2.97%)  1/18 (5.56%) 
PANCREATITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
SMALL INTESTINAL OBSTRUCTION † 1  0/101 (0.00%)  1/18 (5.56%) 
STOMATITIS † 1  0/101 (0.00%)  1/18 (5.56%) 
VOMITING † 1  4/101 (3.96%)  1/18 (5.56%) 
General disorders     
DEATH † 1  1/101 (0.99%)  0/18 (0.00%) 
FATIGUE † 1  2/101 (1.98%)  0/18 (0.00%) 
INFLUENZA LIKE ILLNESS † 1  2/101 (1.98%)  0/18 (0.00%) 
MUCOSAL INFLAMMATION † 1  0/101 (0.00%)  1/18 (5.56%) 
OEDEMA PERIPHERAL † 1  1/101 (0.99%)  0/18 (0.00%) 
PYREXIA † 1  4/101 (3.96%)  1/18 (5.56%) 
Hepatobiliary disorders     
CHOLECYSTITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
CHOLELITHIASIS † 1  1/101 (0.99%)  0/18 (0.00%) 
HEPATITIS ACUTE † 1  1/101 (0.99%)  0/18 (0.00%) 
Immune system disorders     
CYTOKINE RELEASE SYNDROME † 1  1/101 (0.99%)  0/18 (0.00%) 
Infections and infestations     
BACILLUS INFECTION † 1  0/101 (0.00%)  1/18 (5.56%) 
CELLULITIS ORBITAL † 1  0/101 (0.00%)  1/18 (5.56%) 
CLOSTRIDIUM DIFFICILE INFECTION † 1  1/101 (0.99%)  0/18 (0.00%) 
GASTROENTERITIS † 1  0/101 (0.00%)  1/18 (5.56%) 
MENINGITIS BACTERIAL † 1  0/101 (0.00%)  1/18 (5.56%) 
ORBITAL INFECTION † 1  0/101 (0.00%)  1/18 (5.56%) 
PNEUMONIA † 1  2/101 (1.98%)  1/18 (5.56%) 
RASH PUSTULAR † 1  0/101 (0.00%)  1/18 (5.56%) 
SEPSIS † 1  0/101 (0.00%)  1/18 (5.56%) 
SEPTIC SHOCK † 1  1/101 (0.99%)  0/18 (0.00%) 
SKIN INFECTION † 1  1/101 (0.99%)  0/18 (0.00%) 
SOFT TISSUE INFECTION † 1  1/101 (0.99%)  0/18 (0.00%) 
STAPHYLOCOCCAL SEPSIS † 1  0/101 (0.00%)  1/18 (5.56%) 
UPPER RESPIRATORY TRACT INFECTION † 1  0/101 (0.00%)  1/18 (5.56%) 
URINARY TRACT INFECTION † 1  1/101 (0.99%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
HIP FRACTURE † 1  1/101 (0.99%)  0/18 (0.00%) 
SYNOVIAL RUPTURE † 1  1/101 (0.99%)  0/18 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED † 1  7/101 (6.93%)  0/18 (0.00%) 
AMYLASE INCREASED † 1  1/101 (0.99%)  0/18 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED † 1  6/101 (5.94%)  0/18 (0.00%) 
LIPASE INCREASED † 1  1/101 (0.99%)  0/18 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION † 1  1/101 (0.99%)  0/18 (0.00%) 
HYPONATRAEMIA † 1  1/101 (0.99%)  0/18 (0.00%) 
TYPE 1 DIABETES MELLITUS † 1  1/101 (0.99%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN † 1  1/101 (0.99%)  0/18 (0.00%) 
MUSCULAR WEAKNESS † 1  1/101 (0.99%)  0/18 (0.00%) 
MYOSITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
RHABDOMYOLYSIS † 1  1/101 (0.99%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
INTRACRANIAL TUMOUR HAEMORRHAGE † 1  0/101 (0.00%)  1/18 (5.56%) 
MALIGNANT NEOPLASM PROGRESSION † 1  6/101 (5.94%)  9/18 (50.00%) 
TUMOUR PSEUDOPROGRESSION † 1  0/101 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
BRAIN OEDEMA † 1  3/101 (2.97%)  0/18 (0.00%) 
CEREBRAL HAEMORRHAGE † 1  1/101 (0.99%)  0/18 (0.00%) 
DYSAESTHESIA † 1  1/101 (0.99%)  0/18 (0.00%) 
HAEMORRHAGE INTRACRANIAL † 1  3/101 (2.97%)  0/18 (0.00%) 
HEADACHE † 1  1/101 (0.99%)  0/18 (0.00%) 
HEMIPARESIS † 1  1/101 (0.99%)  0/18 (0.00%) 
ISCHAEMIC STROKE † 1  1/101 (0.99%)  0/18 (0.00%) 
LACUNAR INFARCTION † 1  1/101 (0.99%)  0/18 (0.00%) 
METABOLIC ENCEPHALOPATHY † 1  1/101 (0.99%)  0/18 (0.00%) 
PARAESTHESIA † 1  1/101 (0.99%)  0/18 (0.00%) 
PARTIAL SEIZURES † 1  0/101 (0.00%)  1/18 (5.56%) 
PERIPHERAL MOTOR NEUROPATHY † 1  1/101 (0.99%)  0/18 (0.00%) 
PERIPHERAL SENSORY NEUROPATHY † 1  2/101 (1.98%)  0/18 (0.00%) 
PRESYNCOPE † 1  1/101 (0.99%)  0/18 (0.00%) 
SEIZURE † 1  3/101 (2.97%)  1/18 (5.56%) 
SYNCOPE † 1  1/101 (0.99%)  0/18 (0.00%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY † 1  3/101 (2.97%)  0/18 (0.00%) 
IMMUNE-MEDIATED NEPHRITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
NEPHRITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA † 1  2/101 (1.98%)  0/18 (0.00%) 
GRANULOMATOUS PNEUMONITIS † 1  1/101 (0.99%)  0/18 (0.00%) 
LUNG DISORDER † 1  0/101 (0.00%)  1/18 (5.56%) 
PLEURAL EFFUSION † 1  0/101 (0.00%)  1/18 (5.56%) 
PNEUMONITIS † 1  4/101 (3.96%)  1/18 (5.56%) 
PULMONARY EMBOLISM † 1  3/101 (2.97%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders     
RASH MACULO-PAPULAR † 1  1/101 (0.99%)  0/18 (0.00%) 
Vascular disorders     
EMBOLISM † 1  1/101 (0.99%)  0/18 (0.00%) 
HYPOTENSION † 1  3/101 (2.97%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   97/101 (96.04%)   18/18 (100.00%) 
Blood and lymphatic system disorders     
ANAEMIA † 1  16/101 (15.84%)  1/18 (5.56%) 
Cardiac disorders     
ATRIAL FIBRILLATION † 1  2/101 (1.98%)  1/18 (5.56%) 
SINUS TACHYCARDIA † 1  6/101 (5.94%)  1/18 (5.56%) 
TACHYCARDIA † 1  4/101 (3.96%)  1/18 (5.56%) 
Ear and labyrinth disorders     
EAR PAIN † 1  1/101 (0.99%)  2/18 (11.11%) 
TINNITUS † 1  3/101 (2.97%)  1/18 (5.56%) 
Endocrine disorders     
ADRENAL INSUFFICIENCY † 1  10/101 (9.90%)  0/18 (0.00%) 
HYPERTHYROIDISM † 1  14/101 (13.86%)  0/18 (0.00%) 
HYPOGONADISM † 1  0/101 (0.00%)  1/18 (5.56%) 
HYPOPHYSITIS † 1  11/101 (10.89%)  2/18 (11.11%) 
HYPOTHYROIDISM † 1  26/101 (25.74%)  1/18 (5.56%) 
THYROIDITIS † 1  4/101 (3.96%)  1/18 (5.56%) 
Eye disorders     
IRITIS † 1  0/101 (0.00%)  2/18 (11.11%) 
OCULAR HYPERAEMIA † 1  2/101 (1.98%)  1/18 (5.56%) 
PHOTOPHOBIA † 1  2/101 (1.98%)  1/18 (5.56%) 
PHOTOPSIA † 1  2/101 (1.98%)  2/18 (11.11%) 
VISION BLURRED † 1  14/101 (13.86%)  5/18 (27.78%) 
VISUAL ACUITY REDUCED † 1  0/101 (0.00%)  1/18 (5.56%) 
VISUAL IMPAIRMENT † 1  4/101 (3.96%)  1/18 (5.56%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION † 1  5/101 (4.95%)  2/18 (11.11%) 
ABDOMINAL PAIN † 1  19/101 (18.81%)  3/18 (16.67%) 
ABDOMINAL PAIN UPPER † 1  8/101 (7.92%)  0/18 (0.00%) 
ABDOMINAL TENDERNESS † 1  2/101 (1.98%)  1/18 (5.56%) 
APHTHOUS ULCER † 1  0/101 (0.00%)  1/18 (5.56%) 
ASCITES † 1  1/101 (0.99%)  1/18 (5.56%) 
CONSTIPATION † 1  14/101 (13.86%)  3/18 (16.67%) 
DIARRHOEA † 1  51/101 (50.50%)  8/18 (44.44%) 
DRY MOUTH † 1  9/101 (8.91%)  1/18 (5.56%) 
DYSPEPSIA † 1  8/101 (7.92%)  0/18 (0.00%) 
FLATULENCE † 1  4/101 (3.96%)  2/18 (11.11%) 
GASTROOESOPHAGEAL REFLUX DISEASE † 1  2/101 (1.98%)  1/18 (5.56%) 
NAUSEA † 1  53/101 (52.48%)  10/18 (55.56%) 
ORAL DISORDER † 1  0/101 (0.00%)  1/18 (5.56%) 
STOMATITIS † 1  5/101 (4.95%)  2/18 (11.11%) 
VOMITING † 1  28/101 (27.72%)  6/18 (33.33%) 
General disorders     
ASTHENIA † 1  2/101 (1.98%)  1/18 (5.56%) 
CHILLS † 1  15/101 (14.85%)  3/18 (16.67%) 
DISEASE PROGRESSION † 1  0/101 (0.00%)  1/18 (5.56%) 
FATIGUE † 1  69/101 (68.32%)  8/18 (44.44%) 
GAIT DISTURBANCE † 1  2/101 (1.98%)  2/18 (11.11%) 
INFLUENZA LIKE ILLNESS † 1  13/101 (12.87%)  1/18 (5.56%) 
LOCALISED OEDEMA † 1  1/101 (0.99%)  1/18 (5.56%) 
MALAISE † 1  4/101 (3.96%)  1/18 (5.56%) 
NON-CARDIAC CHEST PAIN † 1  3/101 (2.97%)  1/18 (5.56%) 
OEDEMA † 1  0/101 (0.00%)  1/18 (5.56%) 
OEDEMA PERIPHERAL † 1  18/101 (17.82%)  3/18 (16.67%) 
PAIN † 1  5/101 (4.95%)  1/18 (5.56%) 
PYREXIA † 1  28/101 (27.72%)  4/18 (22.22%) 
Immune system disorders     
CYTOKINE RELEASE SYNDROME † 1  0/101 (0.00%)  1/18 (5.56%) 
HYPERSENSITIVITY † 1  2/101 (1.98%)  1/18 (5.56%) 
Infections and infestations     
CRYPTOCOCCAL FUNGAEMIA † 1  0/101 (0.00%)  1/18 (5.56%) 
IMPETIGO † 1  0/101 (0.00%)  1/18 (5.56%) 
ORAL CANDIDIASIS † 1  6/101 (5.94%)  1/18 (5.56%) 
SINUSITIS † 1  8/101 (7.92%)  1/18 (5.56%) 
TINEA CRURIS † 1  1/101 (0.99%)  1/18 (5.56%) 
UPPER RESPIRATORY TRACT INFECTION † 1  11/101 (10.89%)  1/18 (5.56%) 
URINARY TRACT INFECTION † 1  8/101 (7.92%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
ESCHAR † 1  0/101 (0.00%)  1/18 (5.56%) 
FALL † 1  3/101 (2.97%)  1/18 (5.56%) 
PROCEDURAL PAIN † 1  2/101 (1.98%)  1/18 (5.56%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED † 1  41/101 (40.59%)  6/18 (33.33%) 
AMYLASE INCREASED † 1  17/101 (16.83%)  1/18 (5.56%) 
ASPARTATE AMINOTRANSFERASE INCREASED † 1  39/101 (38.61%)  3/18 (16.67%) 
BLOOD ALKALINE PHOSPHATASE INCREASED † 1  12/101 (11.88%)  2/18 (11.11%) 
BLOOD BILIRUBIN INCREASED † 1  7/101 (6.93%)  1/18 (5.56%) 
BLOOD CREATININE INCREASED † 1  7/101 (6.93%)  2/18 (11.11%) 
LIPASE INCREASED † 1  25/101 (24.75%)  1/18 (5.56%) 
LIVER FUNCTION TEST INCREASED † 1  2/101 (1.98%)  1/18 (5.56%) 
LYMPHOCYTE COUNT DECREASED † 1  8/101 (7.92%)  1/18 (5.56%) 
PLATELET COUNT DECREASED † 1  9/101 (8.91%)  0/18 (0.00%) 
WEIGHT DECREASED † 1  15/101 (14.85%)  2/18 (11.11%) 
WEIGHT INCREASED † 1  7/101 (6.93%)  0/18 (0.00%) 
WHITE BLOOD CELL COUNT DECREASED † 1  6/101 (5.94%)  0/18 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  30/101 (29.70%)  4/18 (22.22%) 
DEHYDRATION † 1  11/101 (10.89%)  3/18 (16.67%) 
HYPERGLYCAEMIA † 1  11/101 (10.89%)  2/18 (11.11%) 
HYPERKALAEMIA † 1  9/101 (8.91%)  1/18 (5.56%) 
HYPOALBUMINAEMIA † 1  7/101 (6.93%)  0/18 (0.00%) 
HYPOGLYCAEMIA † 1  1/101 (0.99%)  1/18 (5.56%) 
HYPOKALAEMIA † 1  15/101 (14.85%)  1/18 (5.56%) 
HYPOMAGNESAEMIA † 1  9/101 (8.91%)  3/18 (16.67%) 
HYPONATRAEMIA † 1  14/101 (13.86%)  4/18 (22.22%) 
HYPOPHOSPHATAEMIA † 1  5/101 (4.95%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  36/101 (35.64%)  1/18 (5.56%) 
BACK PAIN † 1  19/101 (18.81%)  4/18 (22.22%) 
GROIN PAIN † 1  1/101 (0.99%)  1/18 (5.56%) 
MUSCLE SPASMS † 1  5/101 (4.95%)  1/18 (5.56%) 
MUSCULAR WEAKNESS † 1  11/101 (10.89%)  3/18 (16.67%) 
MYALGIA † 1  17/101 (16.83%)  0/18 (0.00%) 
NECK PAIN † 1  3/101 (2.97%)  1/18 (5.56%) 
PAIN IN EXTREMITY † 1  11/101 (10.89%)  2/18 (11.11%) 
PAIN IN JAW † 1  0/101 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
TUMOUR PSEUDOPROGRESSION † 1  0/101 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
AMNESIA † 1  1/101 (0.99%)  1/18 (5.56%) 
APHASIA † 1  6/101 (5.94%)  3/18 (16.67%) 
ATAXIA † 1  2/101 (1.98%)  1/18 (5.56%) 
BALANCE DISORDER † 1  0/101 (0.00%)  1/18 (5.56%) 
COORDINATION ABNORMAL † 1  1/101 (0.99%)  1/18 (5.56%) 
DIZZINESS † 1  18/101 (17.82%)  4/18 (22.22%) 
DYSARTHRIA † 1  0/101 (0.00%)  1/18 (5.56%) 
DYSGEUSIA † 1  7/101 (6.93%)  0/18 (0.00%) 
HAEMORRHAGE INTRACRANIAL † 1  4/101 (3.96%)  1/18 (5.56%) 
HEADACHE † 1  52/101 (51.49%)  8/18 (44.44%) 
HYPOAESTHESIA † 1  4/101 (3.96%)  1/18 (5.56%) 
LETHARGY † 1  1/101 (0.99%)  1/18 (5.56%) 
MEMORY IMPAIRMENT † 1  2/101 (1.98%)  1/18 (5.56%) 
PARAESTHESIA † 1  11/101 (10.89%)  1/18 (5.56%) 
PAROSMIA † 1  0/101 (0.00%)  1/18 (5.56%) 
PERIPHERAL MOTOR NEUROPATHY † 1  0/101 (0.00%)  1/18 (5.56%) 
PERIPHERAL SENSORY NEUROPATHY † 1  7/101 (6.93%)  1/18 (5.56%) 
PRESYNCOPE † 1  1/101 (0.99%)  1/18 (5.56%) 
SEIZURE † 1  3/101 (2.97%)  2/18 (11.11%) 
SYNCOPE † 1  4/101 (3.96%)  2/18 (11.11%) 
Psychiatric disorders     
ANXIETY † 1  5/101 (4.95%)  2/18 (11.11%) 
CONFUSIONAL STATE † 1  7/101 (6.93%)  3/18 (16.67%) 
DEPRESSION † 1  6/101 (5.94%)  1/18 (5.56%) 
INSOMNIA † 1  23/101 (22.77%)  5/18 (27.78%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY † 1  2/101 (1.98%)  1/18 (5.56%) 
NEPHRITIS † 1  0/101 (0.00%)  1/18 (5.56%) 
NOCTURIA † 1  2/101 (1.98%)  1/18 (5.56%) 
URINARY RETENTION † 1  0/101 (0.00%)  1/18 (5.56%) 
Reproductive system and breast disorders     
VULVOVAGINAL DRYNESS † 1  0/101 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  33/101 (32.67%)  6/18 (33.33%) 
DYSPHONIA † 1  1/101 (0.99%)  1/18 (5.56%) 
DYSPNOEA † 1  17/101 (16.83%)  3/18 (16.67%) 
DYSPNOEA EXERTIONAL † 1  4/101 (3.96%)  1/18 (5.56%) 
HYPOXIA † 1  2/101 (1.98%)  1/18 (5.56%) 
INCREASED BRONCHIAL SECRETION † 1  0/101 (0.00%)  1/18 (5.56%) 
NASAL CONGESTION † 1  15/101 (14.85%)  2/18 (11.11%) 
OROPHARYNGEAL PAIN † 1  6/101 (5.94%)  3/18 (16.67%) 
PLEURAL EFFUSION † 1  0/101 (0.00%)  1/18 (5.56%) 
PNEUMONITIS † 1  9/101 (8.91%)  1/18 (5.56%) 
PRODUCTIVE COUGH † 1  3/101 (2.97%)  1/18 (5.56%) 
TACHYPNOEA † 1  1/101 (0.99%)  1/18 (5.56%) 
WHEEZING † 1  2/101 (1.98%)  2/18 (11.11%) 
Skin and subcutaneous tissue disorders     
ALOPECIA † 1  4/101 (3.96%)  1/18 (5.56%) 
DERMATITIS ACNEIFORM † 1  5/101 (4.95%)  2/18 (11.11%) 
DRY SKIN † 1  10/101 (9.90%)  3/18 (16.67%) 
HYPERHIDROSIS † 1  6/101 (5.94%)  1/18 (5.56%) 
MACULE † 1  0/101 (0.00%)  1/18 (5.56%) 
NIGHT SWEATS † 1  6/101 (5.94%)  0/18 (0.00%) 
ONYCHOMADESIS † 1  0/101 (0.00%)  1/18 (5.56%) 
PHOTOSENSITIVITY REACTION † 1  1/101 (0.99%)  1/18 (5.56%) 
PRURITUS † 1  42/101 (41.58%)  4/18 (22.22%) 
RASH † 1  14/101 (13.86%)  3/18 (16.67%) 
RASH MACULAR † 1  3/101 (2.97%)  1/18 (5.56%) 
RASH MACULO-PAPULAR † 1  42/101 (41.58%)  5/18 (27.78%) 
RASH PRURITIC † 1  5/101 (4.95%)  2/18 (11.11%) 
SKIN HYPOPIGMENTATION † 1  10/101 (9.90%)  1/18 (5.56%) 
VITILIGO † 1  7/101 (6.93%)  0/18 (0.00%) 
Vascular disorders     
HOT FLUSH † 1  5/101 (4.95%)  1/18 (5.56%) 
HYPERTENSION † 1  13/101 (12.87%)  0/18 (0.00%) 
HYPOTENSION † 1  9/101 (8.91%)  1/18 (5.56%) 
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email:
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02320058    
Other Study ID Numbers: CA209-204
First Submitted: December 16, 2014
First Posted: December 19, 2014
Results First Submitted: September 8, 2021
Results First Posted: October 5, 2021
Last Update Posted: October 5, 2021