Clinical trial

A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

Name

CA209-548

Description

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

Trial arms

Trial start

2016-05-09

Estimated PCD

2020-12-22

Trial end

2024-04-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Nivolumab

Arms:

Nivolumab + Temozolomide + Radiotherapy

Other names:

Opdivo, Nivo, N, BMS-936558

Temozolomide

Arms:

Nivolumab + Temozolomide + Radiotherapy, Nivolumab placebo + Temozolomide + Radiotherapy

Other names:

Temodar, TMZ, Temodal, Temcad

Radiotherapy

Arms:

Nivolumab + Temozolomide + Radiotherapy, Nivolumab placebo + Temozolomide + Radiotherapy

Other names:

Nivolumab Placebo

Arms:

Nivolumab placebo + Temozolomide + Radiotherapy

Size

716

Primary endpoint

Progression-free Survival (PFS) Determined by BICR

From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

Overall Survival (OS)

From randomization to date of death (up to approximately 4.5 years)

Eligibility criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Males and Females, age ≥ 18 years old * Newly diagnosed brain cancer or tumor called glioblastoma or GBM * Karnofsky performance status of ≥ 70 (able to take care of self) * Substantial recovery from surgery resection * Tumor test result shows MGMT methylated or indeterminate tumor subtype Exclusion Criteria: * Biopsy-only of GBM with less than 20% of tumor removed * 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 Other protocol defined inclusion/exclusion criteria could apply

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 716, 'type': 'ACTUAL'}}

Updated at

2024-02-29

1 organization

2 products

1 indication

Product

Indication

Product

Organization