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An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate548)

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: NCT02667587
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Results First Posted : February 3, 2022
Last Update Posted : December 27, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Brain Neoplasms
Interventions Drug: Nivolumab
Drug: Temozolomide
Radiation: Radiotherapy
Other: Nivolumab Placebo
Enrollment 716
Recruitment Details  
Pre-assignment Details 716 participants were randomized into the study, 709 participants received study treatment
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Period Title: Pre-Treatment
Started 358 358
Completed 354 355
Not Completed 4 3
Reason Not Completed
Not reported             1             0
Participant no longer meets study criteria             2             2
Participant withdrew consent             0             1
Adverse event unrelated to study drug             1             0
Period Title: End of Treatment
Started 355 [1] 354 [1]
Completed [2] 37 44
Not Completed 318 310
Reason Not Completed
Other reasons             11             8
Participant no Longer Meets Study Criteria             1             2
Poor/Non-Compliance             0             1
Maximum Clinical Benefit             3             3
Participant Withdrew Consent             5             6
Participants Request to Discontinue Study Treatment             25             26
Adverse Event Unrelated to Study Drug             19             20
Death             2             1
Study Drug Toxicity             74             18
Disease progression             177             222
Lost to Follow-up             1             3
[1]
1 participant was randomized to Radiotherapy, Temozolomide plus Placebo but received Radiotherapy, Temozolomide plus Nivolumab.
[2]
CONTINUING IN THE TREATMENT PERIOD
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo Total
Hide Arm/Group Description Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Total of all reporting groups
Overall Number of Baseline Participants 358 358 716
Hide Baseline Analysis Population Description
Demographic characteristics are based off all randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 358 participants 358 participants 716 participants
57.9  (12.2) 58.7  (11.4) 58.3  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 358 participants 716 participants
Female
153
  42.7%
161
  45.0%
314
  43.9%
Male
205
  57.3%
197
  55.0%
402
  56.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 358 participants 716 participants
Hispanic or Latino
7
   2.0%
11
   3.1%
18
   2.5%
Not Hispanic or Latino
171
  47.8%
178
  49.7%
349
  48.7%
Unknown or Not Reported
180
  50.3%
169
  47.2%
349
  48.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 358 participants 716 participants
White
301
  84.1%
318
  88.8%
619
  86.5%
Black or African American
4
   1.1%
4
   1.1%
8
   1.1%
Asian
35
   9.8%
33
   9.2%
68
   9.5%
Other
17
   4.7%
3
   0.8%
20
   2.8%
Not Reported
1
   0.3%
0
   0.0%
1
   0.1%
1.Primary Outcome
Title Progression-free Survival (PFS) Determined by BICR
Hide Description The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
Time Frame From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description:
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Overall Number of Participants Analyzed 358 358
Median (95% Confidence Interval)
Unit of Measure: Months
10.64
(8.90 to 11.79)
10.32
(9.69 to 12.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiotherapy, Temozolomide Plus Nivolumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.90 to 1.25
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS)
Hide Description The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.
Time Frame From randomization to date of death (up to approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description:
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Overall Number of Participants Analyzed 358 358
Median (95% Confidence Interval)
Unit of Measure: Months
All randomized participants Number Analyzed 358 participants 358 participants
28.91
(24.38 to 31.57)
32.07
(29.37 to 33.77)
All randomized participants without baseline corticosteroids Number Analyzed 246 participants 262 participants
31.34
(28.62 to 34.76)
32.99
(31.01 to 35.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiotherapy, Temozolomide Plus Nivolumab
Comments All Randomized No Baseline Corticosteroids Participants
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3402
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.12
Confidence Interval (2-Sided) 96.39%
0.87 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Radiotherapy, Temozolomide Plus Nivolumab
Comments All Randomized Participants
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.91 to 1.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS) Rates at 12 Months
Hide Description Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months
Time Frame From randomization to 12 months after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description:
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Overall Number of Participants Analyzed 358 358
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.7
(78.3 to 86.3)
87.7
(83.8 to 90.8)
4.Secondary Outcome
Title Overall Survival (OS) Rates at 24 Months
Hide Description Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months
Time Frame From randomization to 24 months after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description:
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Overall Number of Participants Analyzed 358 358
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.9
(50.5 to 61.0)
63.3
(58 to 68.2)
5.Secondary Outcome
Title Progression Free Survival (PFS) Based on Investigator Assessment
Hide Description The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
Time Frame From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description:
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Overall Number of Participants Analyzed 358 358
Median (95% Confidence Interval)
Unit of Measure: Months
14.09
(12.62 to 16.56)
15.18
(13.11 to 17.12)
Time Frame From first dose to 100 days after last dose (up to approximately 5 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Hide Arm/Group Description

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).

Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses

Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

All-Cause Mortality
Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   221/355 (62.25%)   216/354 (61.02%) 
Hide Serious Adverse Events
Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   254/355 (71.55%)   214/354 (60.45%) 
Blood and lymphatic system disorders     
Anaemia  1  2/355 (0.56%)  0/354 (0.00%) 
Autoimmune haemolytic anaemia  1  1/355 (0.28%)  0/354 (0.00%) 
Febrile neutropenia  1  3/355 (0.85%)  2/354 (0.56%) 
Haemolysis  1  0/355 (0.00%)  1/354 (0.28%) 
Leukopenia  1  0/355 (0.00%)  1/354 (0.28%) 
Lymphopenia  1  0/355 (0.00%)  1/354 (0.28%) 
Microcytic anaemia  1  1/355 (0.28%)  0/354 (0.00%) 
Neutropenia  1  6/355 (1.69%)  1/354 (0.28%) 
Pancytopenia  1  8/355 (2.25%)  2/354 (0.56%) 
Thrombocytopenia  1  7/355 (1.97%)  7/354 (1.98%) 
Cardiac disorders     
Acute myocardial infarction  1  0/355 (0.00%)  1/354 (0.28%) 
Angina pectoris  1  0/355 (0.00%)  1/354 (0.28%) 
Atrial fibrillation  1  1/355 (0.28%)  0/354 (0.00%) 
Atrial flutter  1  2/355 (0.56%)  0/354 (0.00%) 
Atrial tachycardia  1  1/355 (0.28%)  0/354 (0.00%) 
Bundle branch block right  1  1/355 (0.28%)  0/354 (0.00%) 
Cardiac arrest  1  1/355 (0.28%)  0/354 (0.00%) 
Cardiac failure  1  2/355 (0.56%)  1/354 (0.28%) 
Cardiac failure congestive  1  1/355 (0.28%)  0/354 (0.00%) 
Left ventricular failure  1  0/355 (0.00%)  1/354 (0.28%) 
Myocardial infarction  1  0/355 (0.00%)  1/354 (0.28%) 
Myocarditis  1  1/355 (0.28%)  0/354 (0.00%) 
Pericarditis  1  1/355 (0.28%)  0/354 (0.00%) 
Sinus tachycardia  1  0/355 (0.00%)  1/354 (0.28%) 
Stress cardiomyopathy  1  0/355 (0.00%)  1/354 (0.28%) 
Supraventricular tachycardia  1  1/355 (0.28%)  0/354 (0.00%) 
Ventricular tachycardia  1  1/355 (0.28%)  0/354 (0.00%) 
Congenital, familial and genetic disorders     
Branchial cyst  1  1/355 (0.28%)  0/354 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/355 (0.28%)  0/354 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  2/355 (0.56%)  2/354 (0.56%) 
Diabetes insipidus  1  0/355 (0.00%)  1/354 (0.28%) 
Hypothyroidism  1  3/355 (0.85%)  0/354 (0.00%) 
Eye disorders     
Cataract  1  1/355 (0.28%)  0/354 (0.00%) 
Diplopia  1  1/355 (0.28%)  0/354 (0.00%) 
Eye swelling  1  1/355 (0.28%)  0/354 (0.00%) 
Eyelid ptosis  1  0/355 (0.00%)  1/354 (0.28%) 
Iridocyclitis  1  1/355 (0.28%)  0/354 (0.00%) 
Retinal detachment  1  1/355 (0.28%)  0/354 (0.00%) 
Vision blurred  1  1/355 (0.28%)  0/354 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/355 (0.28%)  1/354 (0.28%) 
Abdominal pain upper  1  0/355 (0.00%)  1/354 (0.28%) 
Autoimmune colitis  1  2/355 (0.56%)  0/354 (0.00%) 
Colitis  1  5/355 (1.41%)  0/354 (0.00%) 
Constipation  1  1/355 (0.28%)  1/354 (0.28%) 
Diarrhoea  1  4/355 (1.13%)  1/354 (0.28%) 
Diverticular perforation  1  1/355 (0.28%)  0/354 (0.00%) 
Dysphagia  1  1/355 (0.28%)  1/354 (0.28%) 
Enterocolitis  1  1/355 (0.28%)  0/354 (0.00%) 
Gastritis  1  1/355 (0.28%)  0/354 (0.00%) 
Gastritis haemorrhagic  1  1/355 (0.28%)  0/354 (0.00%) 
Gastrointestinal haemorrhage  1  0/355 (0.00%)  1/354 (0.28%) 
Intestinal obstruction  1  0/355 (0.00%)  1/354 (0.28%) 
Large intestinal obstruction  1  0/355 (0.00%)  1/354 (0.28%) 
Nausea  1  4/355 (1.13%)  1/354 (0.28%) 
Oesophagitis  1  1/355 (0.28%)  0/354 (0.00%) 
Vomiting  1  2/355 (0.56%)  3/354 (0.85%) 
General disorders     
Asthenia  1  3/355 (0.85%)  3/354 (0.85%) 
Cyst  1  1/355 (0.28%)  0/354 (0.00%) 
Death  1  4/355 (1.13%)  3/354 (0.85%) 
Drowning  1  1/355 (0.28%)  0/354 (0.00%) 
Euthanasia  1  1/355 (0.28%)  0/354 (0.00%) 
Fatigue  1  2/355 (0.56%)  1/354 (0.28%) 
Gait disturbance  1  0/355 (0.00%)  1/354 (0.28%) 
Gait inability  1  0/355 (0.00%)  1/354 (0.28%) 
General physical health deterioration  1  8/355 (2.25%)  4/354 (1.13%) 
Hyperthermia  1  1/355 (0.28%)  0/354 (0.00%) 
Influenza like illness  1  2/355 (0.56%)  0/354 (0.00%) 
Localised oedema  1  0/355 (0.00%)  1/354 (0.28%) 
Malaise  1  1/355 (0.28%)  0/354 (0.00%) 
Non-cardiac chest pain  1  1/355 (0.28%)  0/354 (0.00%) 
Oedema peripheral  1  1/355 (0.28%)  0/354 (0.00%) 
Pyrexia  1  16/355 (4.51%)  4/354 (1.13%) 
Sudden death  1  2/355 (0.56%)  3/354 (0.85%) 
Systemic inflammatory response syndrome  1  1/355 (0.28%)  0/354 (0.00%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  3/355 (0.85%)  0/354 (0.00%) 
Cholecystitis  1  1/355 (0.28%)  0/354 (0.00%) 
Cholelithiasis  1  1/355 (0.28%)  0/354 (0.00%) 
Drug-induced liver injury  1  1/355 (0.28%)  1/354 (0.28%) 
Haemorrhagic hepatic cyst  1  0/355 (0.00%)  1/354 (0.28%) 
Hepatic function abnormal  1  2/355 (0.56%)  0/354 (0.00%) 
Hepatitis  1  3/355 (0.85%)  0/354 (0.00%) 
Hepatitis acute  1  1/355 (0.28%)  1/354 (0.28%) 
Hepatocellular injury  1  0/355 (0.00%)  1/354 (0.28%) 
Hepatotoxicity  1  0/355 (0.00%)  1/354 (0.28%) 
Liver disorder  1  1/355 (0.28%)  0/354 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/355 (0.28%)  0/354 (0.00%) 
Hypersensitivity  1  3/355 (0.85%)  1/354 (0.28%) 
Immunodeficiency  1  1/355 (0.28%)  0/354 (0.00%) 
Infections and infestations     
Abscess limb  1  0/355 (0.00%)  1/354 (0.28%) 
Appendicitis  1  0/355 (0.00%)  2/354 (0.56%) 
Bacterial infection  1  1/355 (0.28%)  0/354 (0.00%) 
COVID-19  1  1/355 (0.28%)  1/354 (0.28%) 
Cellulitis  1  1/355 (0.28%)  1/354 (0.28%) 
Cystitis  1  1/355 (0.28%)  0/354 (0.00%) 
Device related infection  1  0/355 (0.00%)  1/354 (0.28%) 
Diverticulitis  1  0/355 (0.00%)  1/354 (0.28%) 
Encephalitis  1  1/355 (0.28%)  2/354 (0.56%) 
Gastrointestinal infection  1  0/355 (0.00%)  1/354 (0.28%) 
Herpes simplex  1  1/355 (0.28%)  0/354 (0.00%) 
Herpes zoster  1  5/355 (1.41%)  1/354 (0.28%) 
Influenza  1  0/355 (0.00%)  2/354 (0.56%) 
Intervertebral discitis  1  1/355 (0.28%)  0/354 (0.00%) 
Meningitis  1  1/355 (0.28%)  2/354 (0.56%) 
Meningitis viral  1  1/355 (0.28%)  0/354 (0.00%) 
Parotitis  1  1/355 (0.28%)  0/354 (0.00%) 
Pneumocystis jirovecii pneumonia  1  1/355 (0.28%)  0/354 (0.00%) 
Pneumonia  1  14/355 (3.94%)  5/354 (1.41%) 
Pneumonia viral  1  1/355 (0.28%)  0/354 (0.00%) 
Postoperative wound infection  1  0/355 (0.00%)  2/354 (0.56%) 
Pulmonary sepsis  1  1/355 (0.28%)  0/354 (0.00%) 
Pyometra  1  0/355 (0.00%)  1/354 (0.28%) 
Respiratory tract infection  1  1/355 (0.28%)  0/354 (0.00%) 
Rhinitis  1  0/355 (0.00%)  1/354 (0.28%) 
Sepsis  1  4/355 (1.13%)  1/354 (0.28%) 
Septic shock  1  2/355 (0.56%)  0/354 (0.00%) 
Sinusitis  1  1/355 (0.28%)  0/354 (0.00%) 
Staphylococcal bacteraemia  1  1/355 (0.28%)  0/354 (0.00%) 
Upper respiratory tract infection  1  0/355 (0.00%)  1/354 (0.28%) 
Urinary tract infection  1  6/355 (1.69%)  4/354 (1.13%) 
Urosepsis  1  0/355 (0.00%)  1/354 (0.28%) 
Wound infection  1  1/355 (0.28%)  1/354 (0.28%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  0/355 (0.00%)  1/354 (0.28%) 
Compression fracture  1  0/355 (0.00%)  2/354 (0.56%) 
Fall  1  3/355 (0.85%)  2/354 (0.56%) 
Femoral neck fracture  1  1/355 (0.28%)  1/354 (0.28%) 
Femur fracture  1  0/355 (0.00%)  1/354 (0.28%) 
Foreign body  1  0/355 (0.00%)  1/354 (0.28%) 
Hip fracture  1  1/355 (0.28%)  0/354 (0.00%) 
Incision site swelling  1  0/355 (0.00%)  1/354 (0.28%) 
Lumbar vertebral fracture  1  1/355 (0.28%)  1/354 (0.28%) 
Overdose  1  0/355 (0.00%)  1/354 (0.28%) 
Post procedural complication  1  0/355 (0.00%)  1/354 (0.28%) 
Postoperative wound complication  1  1/355 (0.28%)  0/354 (0.00%) 
Radiation necrosis  1  0/355 (0.00%)  1/354 (0.28%) 
Radiation skin injury  1  1/355 (0.28%)  0/354 (0.00%) 
Spinal compression fracture  1  1/355 (0.28%)  0/354 (0.00%) 
Spinal fracture  1  2/355 (0.56%)  2/354 (0.56%) 
Subdural haematoma  1  1/355 (0.28%)  2/354 (0.56%) 
Toxicity to various agents  1  0/355 (0.00%)  1/354 (0.28%) 
Traumatic intracranial haemorrhage  1  1/355 (0.28%)  0/354 (0.00%) 
Wound complication  1  1/355 (0.28%)  0/354 (0.00%) 
Wound dehiscence  1  1/355 (0.28%)  2/354 (0.56%) 
Investigations     
Alanine aminotransferase increased  1  3/355 (0.85%)  1/354 (0.28%) 
Aspartate aminotransferase increased  1  2/355 (0.56%)  0/354 (0.00%) 
Blood bilirubin increased  1  1/355 (0.28%)  0/354 (0.00%) 
Influenza A virus test positive  1  0/355 (0.00%)  1/354 (0.28%) 
Neutrophil count decreased  1  2/355 (0.56%)  1/354 (0.28%) 
Platelet count decreased  1  6/355 (1.69%)  3/354 (0.85%) 
White blood cell count decreased  1  4/355 (1.13%)  1/354 (0.28%) 
Metabolism and nutrition disorders     
Adult failure to thrive  1  0/355 (0.00%)  1/354 (0.28%) 
Decreased appetite  1  2/355 (0.56%)  1/354 (0.28%) 
Dehydration  1  3/355 (0.85%)  4/354 (1.13%) 
Diabetes mellitus  1  1/355 (0.28%)  0/354 (0.00%) 
Failure to thrive  1  1/355 (0.28%)  0/354 (0.00%) 
Hyperglycaemia  1  2/355 (0.56%)  1/354 (0.28%) 
Hyponatraemia  1  2/355 (0.56%)  1/354 (0.28%) 
Musculoskeletal and connective tissue disorders     
Ankylosing spondylitis  1  1/355 (0.28%)  0/354 (0.00%) 
Arthritis  1  0/355 (0.00%)  1/354 (0.28%) 
Autoimmune myositis  1  1/355 (0.28%)  0/354 (0.00%) 
Back pain  1  0/355 (0.00%)  1/354 (0.28%) 
Eosinophilic fasciitis  1  1/355 (0.28%)  0/354 (0.00%) 
Intervertebral disc protrusion  1  1/355 (0.28%)  0/354 (0.00%) 
Mobility decreased  1  1/355 (0.28%)  0/354 (0.00%) 
Muscular weakness  1  3/355 (0.85%)  3/354 (0.85%) 
Osteoarthritis  1  0/355 (0.00%)  1/354 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic leukaemia  1  0/355 (0.00%)  1/354 (0.28%) 
Glioblastoma  1  7/355 (1.97%)  12/354 (3.39%) 
Glioblastoma multiforme  1  0/355 (0.00%)  1/354 (0.28%) 
Malignant melanoma  1  0/355 (0.00%)  1/354 (0.28%) 
Malignant melanoma in situ  1  1/355 (0.28%)  0/354 (0.00%) 
Malignant neoplasm progression  1  70/355 (19.72%)  70/354 (19.77%) 
Metastases to meninges  1  1/355 (0.28%)  0/354 (0.00%) 
Neoplasm  1  0/355 (0.00%)  2/354 (0.56%) 
Neoplasm progression  1  6/355 (1.69%)  11/354 (3.11%) 
Non-small cell lung cancer  1  0/355 (0.00%)  1/354 (0.28%) 
Peritumoural oedema  1  1/355 (0.28%)  0/354 (0.00%) 
Recurrent cancer  1  2/355 (0.56%)  0/354 (0.00%) 
Squamous cell carcinoma  1  1/355 (0.28%)  0/354 (0.00%) 
Tumour flare  1  10/355 (2.82%)  7/354 (1.98%) 
Tumour pseudoprogression  1  0/355 (0.00%)  1/354 (0.28%) 
Nervous system disorders     
Acute disseminated encephalomyelitis  1  1/355 (0.28%)  0/354 (0.00%) 
Altered state of consciousness  1  0/355 (0.00%)  1/354 (0.28%) 
Aphasia  1  3/355 (0.85%)  5/354 (1.41%) 
Brain oedema  1  8/355 (2.25%)  8/354 (2.26%) 
Central nervous system lesion  1  0/355 (0.00%)  1/354 (0.28%) 
Central nervous system necrosis  1  0/355 (0.00%)  1/354 (0.28%) 
Cerebral cyst  1  1/355 (0.28%)  1/354 (0.28%) 
Cerebral haemorrhage  1  0/355 (0.00%)  1/354 (0.28%) 
Cerebral infarction  1  1/355 (0.28%)  3/354 (0.85%) 
Cerebral ischaemia  1  2/355 (0.56%)  3/354 (0.85%) 
Cerebral venous sinus thrombosis  1  1/355 (0.28%)  0/354 (0.00%) 
Cerebrospinal fluid leakage  1  3/355 (0.85%)  1/354 (0.28%) 
Cerebrovascular accident  1  4/355 (1.13%)  2/354 (0.56%) 
Cognitive disorder  1  2/355 (0.56%)  6/354 (1.69%) 
Coma  1  1/355 (0.28%)  0/354 (0.00%) 
Depressed level of consciousness  1  0/355 (0.00%)  1/354 (0.28%) 
Dizziness  1  1/355 (0.28%)  4/354 (1.13%) 
Drooling  1  1/355 (0.28%)  0/354 (0.00%) 
Dysarthria  1  1/355 (0.28%)  0/354 (0.00%) 
Encephalopathy  1  4/355 (1.13%)  5/354 (1.41%) 
Epilepsy  1  15/355 (4.23%)  12/354 (3.39%) 
Generalised tonic-clonic seizure  1  2/355 (0.56%)  1/354 (0.28%) 
Haemorrhage intracranial  1  3/355 (0.85%)  2/354 (0.56%) 
Headache  1  7/355 (1.97%)  6/354 (1.69%) 
Hemiparesis  1  6/355 (1.69%)  9/354 (2.54%) 
Hemiplegia  1  3/355 (0.85%)  0/354 (0.00%) 
Hydrocephalus  1  10/355 (2.82%)  8/354 (2.26%) 
Intracranial pressure increased  1  1/355 (0.28%)  3/354 (0.85%) 
Lacunar infarction  1  0/355 (0.00%)  1/354 (0.28%) 
Lethargy  1  0/355 (0.00%)  1/354 (0.28%) 
Nervous system disorder  1  0/355 (0.00%)  2/354 (0.56%) 
Neurological decompensation  1  0/355 (0.00%)  2/354 (0.56%) 
Neurological symptom  1  0/355 (0.00%)  1/354 (0.28%) 
Neuropathy peripheral  1  1/355 (0.28%)  0/354 (0.00%) 
Optic neuritis  1  1/355 (0.28%)  0/354 (0.00%) 
Partial seizures  1  3/355 (0.85%)  1/354 (0.28%) 
Psychomotor skills impaired  1  1/355 (0.28%)  0/354 (0.00%) 
Radiculopathy  1  2/355 (0.56%)  0/354 (0.00%) 
Seizure  1  46/355 (12.96%)  40/354 (11.30%) 
Simple partial seizures  1  1/355 (0.28%)  0/354 (0.00%) 
Somnolence  1  1/355 (0.28%)  1/354 (0.28%) 
Status epilepticus  1  1/355 (0.28%)  1/354 (0.28%) 
Subdural hygroma  1  1/355 (0.28%)  1/354 (0.28%) 
Syncope  1  2/355 (0.56%)  1/354 (0.28%) 
Vasogenic cerebral oedema  1  0/355 (0.00%)  2/354 (0.56%) 
Product Issues     
Device malfunction  1  0/355 (0.00%)  1/354 (0.28%) 
Psychiatric disorders     
Agitation  1  1/355 (0.28%)  1/354 (0.28%) 
Assisted suicide  1  1/355 (0.28%)  0/354 (0.00%) 
Confusional state  1  2/355 (0.56%)  2/354 (0.56%) 
Delirium  1  1/355 (0.28%)  0/354 (0.00%) 
Depression  1  1/355 (0.28%)  1/354 (0.28%) 
Mental status changes  1  5/355 (1.41%)  0/354 (0.00%) 
Mood altered  1  1/355 (0.28%)  0/354 (0.00%) 
Paranoia  1  1/355 (0.28%)  0/354 (0.00%) 
Suicidal ideation  1  1/355 (0.28%)  0/354 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  4/355 (1.13%)  2/354 (0.56%) 
Haematuria  1  1/355 (0.28%)  0/354 (0.00%) 
Nephritis  1  1/355 (0.28%)  0/354 (0.00%) 
Nephrolithiasis  1  0/355 (0.00%)  1/354 (0.28%) 
Nephropathy  1  1/355 (0.28%)  0/354 (0.00%) 
Renal failure  1  2/355 (0.56%)  0/354 (0.00%) 
Tubulointerstitial nephritis  1  2/355 (0.56%)  0/354 (0.00%) 
Urinary retention  1  0/355 (0.00%)  1/354 (0.28%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/355 (0.00%)  1/354 (0.28%) 
Cystocele  1  1/355 (0.28%)  0/354 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/355 (0.28%)  1/354 (0.28%) 
Dyspnoea  1  3/355 (0.85%)  3/354 (0.85%) 
Hypoxia  1  0/355 (0.00%)  1/354 (0.28%) 
Laryngeal obstruction  1  0/355 (0.00%)  1/354 (0.28%) 
Lung disorder  1  2/355 (0.56%)  0/354 (0.00%) 
Pneumonia aspiration  1  4/355 (1.13%)  1/354 (0.28%) 
Pneumonitis  1  3/355 (0.85%)  1/354 (0.28%) 
Pneumothorax  1  1/355 (0.28%)  0/354 (0.00%) 
Pulmonary embolism  1  9/355 (2.54%)  13/354 (3.67%) 
Pulmonary oedema  1  1/355 (0.28%)  1/354 (0.28%) 
Respiratory disorder  1  0/355 (0.00%)  1/354 (0.28%) 
Respiratory distress  1  1/355 (0.28%)  0/354 (0.00%) 
Respiratory failure  1  0/355 (0.00%)  1/354 (0.28%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  2/355 (0.56%)  0/354 (0.00%) 
Drug reaction with eosinophilia and systemic symptoms  1  1/355 (0.28%)  0/354 (0.00%) 
Rash  1  1/355 (0.28%)  2/354 (0.56%) 
Rash maculo-papular  1  2/355 (0.56%)  2/354 (0.56%) 
Scar pain  1  0/355 (0.00%)  1/354 (0.28%) 
Skin reaction  1  1/355 (0.28%)  0/354 (0.00%) 
Stevens-Johnson syndrome  1  1/355 (0.28%)  0/354 (0.00%) 
Surgical and medical procedures     
Cholecystectomy  1  0/355 (0.00%)  1/354 (0.28%) 
Vascular disorders     
Axillary vein thrombosis  1  0/355 (0.00%)  1/354 (0.28%) 
Deep vein thrombosis  1  2/355 (0.56%)  2/354 (0.56%) 
Embolism  1  4/355 (1.13%)  5/354 (1.41%) 
Hypotension  1  2/355 (0.56%)  1/354 (0.28%) 
Orthostatic hypotension  1  1/355 (0.28%)  0/354 (0.00%) 
Thrombosis  1  2/355 (0.56%)  0/354 (0.00%) 
1
Term from vocabulary, 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy, Temozolomide Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   351/355 (98.87%)   343/354 (96.89%) 
Blood and lymphatic system disorders     
Anaemia  1  42/355 (11.83%)  26/354 (7.34%) 
Leukopenia  1  20/355 (5.63%)  30/354 (8.47%) 
Lymphopenia  1  42/355 (11.83%)  39/354 (11.02%) 
Neutropenia  1  33/355 (9.30%)  32/354 (9.04%) 
Thrombocytopenia  1  68/355 (19.15%)  67/354 (18.93%) 
Endocrine disorders     
Hypothyroidism  1  26/355 (7.32%)  10/354 (2.82%) 
Eye disorders     
Dry eye  1  18/355 (5.07%)  15/354 (4.24%) 
Vision blurred  1  28/355 (7.89%)  23/354 (6.50%) 
Gastrointestinal disorders     
Abdominal pain  1  29/355 (8.17%)  27/354 (7.63%) 
Constipation  1  163/355 (45.92%)  144/354 (40.68%) 
Diarrhoea  1  73/355 (20.56%)  71/354 (20.06%) 
Nausea  1  185/355 (52.11%)  158/354 (44.63%) 
Stomatitis  1  25/355 (7.04%)  9/354 (2.54%) 
Vomiting  1  88/355 (24.79%)  75/354 (21.19%) 
General disorders     
Asthenia  1  41/355 (11.55%)  40/354 (11.30%) 
Chills  1  25/355 (7.04%)  13/354 (3.67%) 
Fatigue  1  186/355 (52.39%)  175/354 (49.44%) 
Gait disturbance  1  27/355 (7.61%)  34/354 (9.60%) 
Malaise  1  16/355 (4.51%)  18/354 (5.08%) 
Oedema peripheral  1  30/355 (8.45%)  28/354 (7.91%) 
Pain  1  19/355 (5.35%)  9/354 (2.54%) 
Pyrexia  1  69/355 (19.44%)  31/354 (8.76%) 
Infections and infestations     
Conjunctivitis  1  20/355 (5.63%)  12/354 (3.39%) 
Nasopharyngitis  1  37/355 (10.42%)  31/354 (8.76%) 
Oral candidiasis  1  20/355 (5.63%)  12/354 (3.39%) 
Upper respiratory tract infection  1  20/355 (5.63%)  19/354 (5.37%) 
Urinary tract infection  1  43/355 (12.11%)  34/354 (9.60%) 
Injury, poisoning and procedural complications     
Fall  1  36/355 (10.14%)  45/354 (12.71%) 
Radiation skin injury  1  35/355 (9.86%)  38/354 (10.73%) 
Investigations     
Alanine aminotransferase increased  1  61/355 (17.18%)  39/354 (11.02%) 
Aspartate aminotransferase increased  1  44/355 (12.39%)  16/354 (4.52%) 
Blood creatinine increased  1  22/355 (6.20%)  14/354 (3.95%) 
Lymphocyte count decreased  1  67/355 (18.87%)  62/354 (17.51%) 
Neutrophil count decreased  1  34/355 (9.58%)  40/354 (11.30%) 
Platelet count decreased  1  75/355 (21.13%)  75/354 (21.19%) 
Weight decreased  1  50/355 (14.08%)  33/354 (9.32%) 
Weight increased  1  10/355 (2.82%)  21/354 (5.93%) 
White blood cell count decreased  1  39/355 (10.99%)  44/354 (12.43%) 
Metabolism and nutrition disorders     
Decreased appetite  1  97/355 (27.32%)  87/354 (24.58%) 
Hyperglycaemia  1  23/355 (6.48%)  34/354 (9.60%) 
Hypokalaemia  1  33/355 (9.30%)  15/354 (4.24%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  59/355 (16.62%)  54/354 (15.25%) 
Back pain  1  39/355 (10.99%)  35/354 (9.89%) 
Muscular weakness  1  33/355 (9.30%)  28/354 (7.91%) 
Myalgia  1  28/355 (7.89%)  15/354 (4.24%) 
Pain in extremity  1  23/355 (6.48%)  16/354 (4.52%) 
Nervous system disorders     
Aphasia  1  30/355 (8.45%)  32/354 (9.04%) 
Cognitive disorder  1  19/355 (5.35%)  19/354 (5.37%) 
Dizziness  1  46/355 (12.96%)  53/354 (14.97%) 
Dysgeusia  1  36/355 (10.14%)  27/354 (7.63%) 
Headache  1  140/355 (39.44%)  134/354 (37.85%) 
Hemiparesis  1  23/355 (6.48%)  24/354 (6.78%) 
Memory impairment  1  25/355 (7.04%)  36/354 (10.17%) 
Paraesthesia  1  26/355 (7.32%)  24/354 (6.78%) 
Seizure  1  61/355 (17.18%)  75/354 (21.19%) 
Tremor  1  22/355 (6.20%)  26/354 (7.34%) 
Psychiatric disorders     
Anxiety  1  30/355 (8.45%)  34/354 (9.60%) 
Confusional state  1  20/355 (5.63%)  21/354 (5.93%) 
Depression  1  29/355 (8.17%)  34/354 (9.60%) 
Insomnia  1  53/355 (14.93%)  46/354 (12.99%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  58/355 (16.34%)  51/354 (14.41%) 
Dyspnoea  1  25/355 (7.04%)  20/354 (5.65%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  114/355 (32.11%)  109/354 (30.79%) 
Dry skin  1  22/355 (6.20%)  27/354 (7.63%) 
Erythema  1  29/355 (8.17%)  21/354 (5.93%) 
Pruritus  1  88/355 (24.79%)  77/354 (21.75%) 
Rash  1  81/355 (22.82%)  58/354 (16.38%) 
Rash maculo-papular  1  31/355 (8.73%)  13/354 (3.67%) 
Vascular disorders     
Hypertension  1  28/355 (7.89%)  32/354 (9.04%) 
1
Term from vocabulary, 23.1
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.
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
Phone: Please email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02667587    
Other Study ID Numbers: CA209-548
2015-004722-34 ( EudraCT Number )
First Submitted: January 26, 2016
First Posted: January 29, 2016
Results First Submitted: November 30, 2021
Results First Posted: February 3, 2022
Last Update Posted: December 27, 2022