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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to date of death (up to approximately 4.5 years)

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,127,798 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can anyone who meets the qualifications join this clinical trial right now?

"This trial is not currently looking for new participants. The date range for this study is from 5/9/2016 to 10/25/2022. For patients exploring other options, 827 trials are actively recruiting brain cancer patients and 958 studies are enrolling candidates for Nivolumab treatment."

Answered by AI

What are the latest findings on Nivolumab's safety and efficacy?

"There is some data supporting the efficacy of Nivolumab and it has undergone multiple rounds of testing, so our team at Power gives it a safety rating of 3."

Answered by AI

Could you please tell me if this medical trial is testing an innovative treatment?

"Nivolumab has been researched since 2002, when the first clinical trial was sponsored by Schering-Plough. Sixty people were included in the original study and, after its success, Nivolumab received Phase 2 drug approval. Now, there are 958 live trials involving this medication taking place across 2426 cities in 52 countries."

Answered by AI

Is this trial being administrated in multiple hospitals across the state?

"There are 73 different hospitals and medical institutions where this trial is taking place. These locations include Local Institution - 0046 in Vancouver, Local Institution - 0011 in Boston, Sharp Memorial Hospital in San Diego, as well other places."

Answered by AI

What else is known about Nivolumab from other research?

"Nivolumab was first studied in 2002 at the Memorial Sloan Kettering Cancer Center. As of now, there have been 658 completed trials worldwide. Out of these 958 active trials, many are being conducted in Vancouver, British Columbia."

Answered by AI

What diseases or conditions does Nivolumab help patients with?

"Nivolumab is a medication that oncologists often prescribe to their patients with malignant neoplasms. Additionally, it can be taken as prophylaxis for those who have undergone treatment for unresectable melanoma or squamous cell carcinoma and are at high risk of recurrence."

Answered by AI