An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Phase 3

Completed

Conditions: Brain Cancer

Interventions: Drug: Nivolumab
Drug: Temozolomide
Radiation: Radiotherapy

Registration Number: NCT02617589

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 560

Inclusion Criteria

Males and Females, age ≥ 18 years old
Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
Tumor test result shows MGMT unmethylated type
Karnofsky performance status of ≥ 70 (able to care for self)

Exclusion Criteria

Prior treatment for GBM (other than surgical resection)
Any known tumor outside of the brain
Recurrent or secondary GBM
Active known or suspected autoimmune disease
Biopsy with less than 20% of tumor removed

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temozolomide + Radiotherapy Arm	Radiotherapy	Temozolomide + Radiotherapy dose as specified
Nivolumab + Radiotherapy Arm	Radiotherapy	Nivolumab IV infusion + Radiotherapy dose as specified
Nivolumab + Radiotherapy Arm	Nivolumab	Nivolumab IV infusion + Radiotherapy dose as specified
Temozolomide + Radiotherapy Arm	Temozolomide	Temozolomide + Radiotherapy dose as specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to 3 years	OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Plot of Progression Free Survival	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)	PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Progression Free Survival in Tumor Mutational Burden (TMB) High Population	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)	PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Overall Survival Rate at 24 Months	At 24 Months	The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Overall Survival in Tumor Mutational Burden (TMB) High Population	From randomization to the date of death due to any cause (up to approximately 6 years)	OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.

Trial Locations

Locations (115): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Local Institution - 0083
🇺🇸
Phoenix, Arizona, United States
Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Local Institution - 0019
🇺🇸
Los Angeles, California, United States
Sutter Institute For Medical Research
🇺🇸
Sacramento, California, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
The Regents of the University of California, San Francisco
🇺🇸
San Francisco, California, United States
Yale Cancer Center
🇺🇸
New Haven, Connecticut, United States
Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
University Of Miami Sylvester Comprehensive Cancer Center
🇺🇸
Miami, Florida, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States