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)

• 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: Bristol-Myers Squibb
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy, Temozolomide Plus Placebo	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS) Determined by BICR
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)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy, Temozolomide Plus Placebo
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)

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)
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)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title		Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy, Temozolomide Plus Placebo
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)

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]

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
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

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy, Temozolomide Plus Placebo
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
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

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy, Temozolomide Plus Placebo
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
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)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy, Temozolomide Plus Placebo
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)

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.

Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

• 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