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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Progression Free Survival at 6 Months
Secondary outcome measures
Number of Adverse Events
Number of Participants With Progression
Number of Participants With Response Rate
+1 more

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 2
~2010
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,346 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,801 Patients Enrolled for Gliosarcoma
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,797,996 Total Patients Enrolled
13 Trials studying Gliosarcoma
683 Patients Enrolled for Gliosarcoma
John F DeGrootPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02337686 — Phase 2
Gliosarcoma Research Study Groups: Treatment (pembrolizumab, surgery)
Gliosarcoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02337686 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02337686 — Phase 2
~2 spots leftby Jun 2025
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