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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
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,628 Total Patients Enrolled
314 Trials studying Glioblastoma
22,428 Patients Enrolled for Glioblastoma
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,431 Total Patients Enrolled
42 Trials studying Glioblastoma
1,951 Patients Enrolled for Glioblastoma
John F DeGrootPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02337686 — Phase 2
Glioblastoma Research Study Groups: Treatment (pembrolizumab, surgery)
Glioblastoma 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

Frequently Asked Questions

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

Has Pembrolizumab received regulatory approval from the FDA?

"Our evaluation of pembrolizumab's safety landed it a score of 2, as there is evidence that supports its security but no proof that attests to its efficacy."

Answered by AI

Is there currently an open enrollment period for this experiment?

"According to clinicaltrials.gov, the protocol for this study is no longer recruiting participants after being posted on April 28th 2015 and last edited on February 3rd 2022. Despite its inactivity, there are 2353 other trials that have opened their doors to volunteers at present."

Answered by AI

What maladies are most often treated with Pembrolizumab?

"In medicine, Pembrolizumab is often prescribed for malignant neoplasms. It also can be beneficial in treating unresectable melanoma, as well as mitigating chemotherapy-induced disease progression or microsatellite instability high conditions."

Answered by AI

Could you provide me with a summary of the prior research conducted surrounding Pembrolizumab?

"Currently, there are 961 active clinical trials scrutinizing the effects of Pembrolizumab and 122 of those studies are at Phase 3. The majority of these research initiatives take place in Houston but other sites across 35731 locations also conduct investigations concerning this drug."

Answered by AI

What is the enrollment capacity of this research study?

"At present, this medical trial is not in the process of recruiting patients. It was first published on April 28th 2015 and last edited on February 3rd 2022. If you are researching other trials, there are 1392 gliosarcoma studies and 961 Pembrolizumab experiments actively enrolling participants."

Answered by AI
~2 spots leftby Mar 2025