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) (CheckMate 498)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Brain Cancer

Treatments: Drug: Nivolumab; Radiation: Radiotherapy; Drug: Temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617589

2015-003739-37 (EudraCT Number)

CA209-498

Details and patient eligibility

About

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.

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

Nivolumab + Radiotherapy Arm

Experimental group

Description:

Nivolumab IV infusion + Radiotherapy dose as specified

Treatment:

Radiation: Radiotherapy

Drug: Nivolumab

Temozolomide + Radiotherapy Arm

Active Comparator group

Description:

Temozolomide + Radiotherapy dose as specified

Treatment:

Drug: Temozolomide

Radiation: Radiotherapy