← Back to Search

Monoclonal Antibodies

Nivolumab vs Bevacizumab, and Nivolumab + Ipilimumab for Brain Cancer (CheckMate 143 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 score of 70 or higher

Participants with histologically confirmed Grade IV malignant glioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization to the date of the first documented tumor progression or death due to any cause (up to 17jun2019, approximately 5 years)

Awards & highlights

CheckMate 143 Trial Summary

This trial is comparing the effectiveness of two different drugs to treat brain cancer. One drug is given alone, and the other is given with another drug. The trial will also look at the side effects of the drugs.

Who is the study for?

This trial is for adults with a specific type of brain cancer called glioblastoma. Participants must have had prior treatment with radiotherapy and temozolomide, or be newly diagnosed with resectable disease. They should have a Karnofsky performance score of 70+ indicating they can care for themselves. Those with more than one recurrence, extracranial metastatic disease, autoimmune diseases, significant heart issues, or previous anti-angiogenic treatments cannot join.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of Nivolumab alone compared to Bevacizumab in recurrent glioblastoma patients. It also examines Nivolumab's use alone or combined with Ipilimumab in various stages of the condition to understand tolerability and potential benefits.See study design

What are the potential side effects?

Nivolumab may cause immune-related reactions affecting different organs, skin rash, fatigue, and respiratory issues. Ipilimumab could lead to similar effects but might also include intestinal problems. Bevacizumab can increase bleeding risk, high blood pressure, and impair wound healing.

CheckMate 143 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to care for myself but cannot do normal activities without help.

Select...

I have been diagnosed with a Grade IV brain tumor.

CheckMate 143 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time between the date of randomization and the date of death due to any cause (up to 17jun2019, approximately 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time between the date of randomization and the date of death due to any cause (up to 17jun2019, approximately 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time between the date of randomization and the date of death due to any cause (up to 17jun2019, approximately 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) for Cohort 2

Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d

Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses

+3 more

Secondary outcome measures

Objective Response Rate (ORR) for Cohort 2

Overall Survival (OS) at 12 Months for Cohort 2

Overall Survival (OS) for Cohorts 1c and 1d

+1 more

CheckMate 143 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm N:NivolumabExperimental Treatment1 Intervention

Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days

Group II: Arm N + I:Nivolumab + IpilimumabExperimental Treatment2 Interventions

Cohort 1: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days Cohort 1b: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days

Group III: Arm B: BevacizumabActive Control1 Intervention

Cohort 2: Bevacizumab specified dose on specified days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2670

Nivolumab

2014

Completed Phase 3

~4750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,127,985 Total Patients Enrolled

19 Trials studying Glioblastoma

2,287 Patients Enrolled for Glioblastoma

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02017717 — Phase 3

Glioblastoma Research Study Groups: Arm N:Nivolumab, Arm B: Bevacizumab, Arm N + I:Nivolumab + Ipilimumab

Glioblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02017717 — Phase 3

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02017717 — Phase 3

Frequently Asked Questions

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

Does Ipilimumab have government permission to be sold as a medication?

"There is evidence from past studies to support the safety of Ipilimumab, as it has gone through multiple Phase 3 trials."

Answered by AI

For what purpose is Ipilimumab most often prescribed?

"Ipilimumab is frequently used to treat melanoma that cannot be surgically removed. Additionally, this immunotherapy medication can be used to lower the risk of cancer recurrence in patients with squamous cell carcinoma and nonsquamous non-small cell lung cancer."

Answered by AI

Can you tell me about other times Ipilimumab has been tested in a clinical setting?

"Ipilimumab was first researched in 2004 at Memoral Sloan Kettering Basking Ridge. So far, there have been 1357 completed clinical trials and 1162 are still ongoing. A large portion of these active trials are located in Tampa, Florida."

Answered by AI