← Back to Search

Checkpoint Inhibitor

Immunotherapy for Recurrent Glioblastoma

Phase 2

Waitlist Available

Led By John F DeGroot

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of pembrolizumab on patients with glioblastoma that has come back. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Who is the study for?

This trial is for adults with recurrent glioblastoma or gliosarcoma who need reoperation. They must have a certain level of physical function, stable steroid use, and adequate organ function. Women of childbearing age must test negative for pregnancy and agree to contraception; men also need to commit to birth control methods.

What is being tested?

The study tests pembrolizumab's effects on recurrent brain tumors after surgery. Pembrolizumab is an immunotherapy drug that may help the immune system fight cancer by blocking tumor growth. The trial includes pharmacological studies and lab biomarker analysis.

What are the potential side effects?

Pembrolizumab can cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid dysfunction), infusion reactions, fatigue, appetite changes, diarrhea or constipation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Progression Free Survival at 6 Months

Secondary study objectives

Number of Adverse Events

Number of Participants With Progression

Number of Participants With Response Rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, surgery)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV over 30 minutes on day -21 and day -1, and then undergo surgery on day 0. After 2-3 weeks or recovery from surgery, patients continue to receive pembrolizumab IV over 30 minutes every 3 weeks. Courses repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9890