Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
18+
Trial acronym
CheckMate 498
Clinical summary
Summary
The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving nivolumab every two weeks in addition to radiation therapy (RT), and then every four weeks, compared with patients receiving standard therapy with temozolomide in addition to RT. **Tumor test result shows MGMT unmethylated type**
Conditions
This trial is treating people with Glioblastoma
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific Title
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma
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