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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
![]() |
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 | |
---|---|---|---|---|
![]() |
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 | |
![]() |
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%
|
Name/Title: | Bristol-Myers Squibb Study Director |
Organization: | Bristol-Myers Squibb |
Phone: | Please email |
EMail: | Clinical.Trials@bms.com |
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 |