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Immunotherapy + Chemoradiotherapy for Glioblastoma (CheckMate548 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status of ≥ 70 (able to take care of self)
Tumor test result shows MGMT methylated or indeterminate tumor subtype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to date of death (up to approximately 4.5 years)
Awards & highlights

CheckMate548 Trial Summary

This trial is testing whether adding the immunotherapy drug nivolumab to standard treatment for glioblastoma improves outcomes.

Who is the study for?
This trial is for adults over 18 with a type of brain cancer called glioblastoma, specifically where the MGMT gene is altered. Participants should be mostly independent in daily activities and have had surgery to remove most of their tumor but no other GBM treatments.Check my eligibility
What is being tested?
The study tests if adding Nivolumab to standard treatment (Temozolomide plus radiation) improves outcomes for patients with newly diagnosed, MGMT-methylated glioblastoma compared to those receiving a placebo alongside standard treatment.See study design
What are the potential side effects?
Nivolumab can cause immune system-related side effects such as inflammation in various organs, skin rash, hormone gland problems, and infusion reactions. Temozolomide may lead to nausea, fatigue, hair loss, and blood cell changes.

CheckMate548 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My tumor is MGMT methylated or of an indeterminate subtype.
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I have been diagnosed with a type of brain cancer known as glioblastoma.

CheckMate548 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to date of death (up to approximately 4.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to date of death (up to approximately 4.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS) Determined by BICR
Secondary outcome measures
Overall Survival (OS) Rates at 12 Months
Overall Survival (OS) Rates at 24 Months
Progression Free Survival (PFS) Based on Investigator Assessment

CheckMate548 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nivolumab + Temozolomide + RadiotherapyExperimental Treatment3 Interventions
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
Group II: Nivolumab placebo + Temozolomide + RadiotherapyPlacebo Group3 Interventions
Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/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 5x/week x 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Temozolomide
2010
Completed Phase 3
~1930
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,116 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,807 Total Patients Enrolled

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT02667587 — Phase 3
Brain Tumor Research Study Groups: Nivolumab placebo + Temozolomide + Radiotherapy, Nivolumab + Temozolomide + Radiotherapy
Brain Tumor Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT02667587 — Phase 3
Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02667587 — Phase 3
~80 spots leftby May 2025
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