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Angiogenesis Inhibitor

Pembrolizumab + Re-irradiation for Glioblastoma

Phase 2
Waitlist Available
Led By David A Reardon, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age on day of signing informed consent
Karnofsky performance status (KPS) ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is researching if combining pembrolizumab with re-irradiation can help treat glioblastoma.

Who is the study for?
This trial is for adults over 18 with confirmed Grade IV glioblastoma, who have had prior radiotherapy and are at their first or second relapse. They must be in good physical condition (KPS ≥ 70), show tumor progression on MRI, and meet specific organ function criteria. Women of childbearing potential and men must use effective contraception. Those with large recurrent tumors, active infections, certain cardiovascular issues, other cancers within a year, or previous treatments with similar drugs cannot participate.Check my eligibility
What is being tested?
The study tests pembrolizumab (an immunotherapy drug) combined with re-irradiation against glioblastoma multiforme (GBM). Bevacizumab—an FDA-approved drug for GBM—is also part of the treatment for some patients. The goal is to see if these treatments can effectively manage GBM when it comes back after initial therapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, skin reactions, fatigue and flu-like symptoms. Re-irradiation might lead to headaches, hair loss at the treated site, nausea or brain swelling. Bevacizumab can increase bleeding risk, cause high blood pressure and impair wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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I've had radiation therapy for a brain tumor before.
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I agree to use contraception as outlined in the study from the first to 120 days after the last dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Objective Response Rate (ORR)
Overall Survival Rate at 12 Months (OS-12)
Overall Survival Rate at 6 Months (OS-6)
Secondary outcome measures
6-month Progression Free Survival (PFS-6)
Duration of Response
Median Overall Survival (OS)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Radiation (lead-in)Experimental Treatment2 Interventions
Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.) Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
Group II: Pembrolizumab + RadiationExperimental Treatment2 Interventions
Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
Group III: Pembrolizumab + Bevacizumab + Radiation (lead-in)Experimental Treatment3 Interventions
Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.) Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
Group IV: Pembrolizumab + Bevacizumab + RadiationExperimental Treatment3 Interventions
Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,926 Total Patients Enrolled
23 Trials studying Glioblastoma
966 Patients Enrolled for Glioblastoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,875 Total Patients Enrolled
30 Trials studying Glioblastoma
2,991 Patients Enrolled for Glioblastoma
David A Reardon, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
96 Total Patients Enrolled
3 Trials studying Glioblastoma
46 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

What has been the primary purpose of prescribing Pembrolizumab?

"Pembrolizumab is a commonly prescribed treatment for unresectable melanoma. It also has the potential to improve outcomes in cases of microsatellite instability high, locally advanced nonsquamous non-small cell lung cancer, and those with heightened risk of recurrence."

Answered by AI

To what extent is the research populace participating in this experiment?

"This trial is no longer accepting new participants. The initial posting date was September 28th 2018 and the last edit occurred on December 7th 2022. At present, 442 studies focusing glioblastoma are actively recruiting subjects while 1296 trials for Pembrolizumab also seek volunteers."

Answered by AI

Is enrollment available to volunteers at present?

"This trial is currently not recruiting, having first been listed on September 28th 2018 and last updated December 7th 2022. Fortunately for those searching for a medical study to join, there are 442 clinical trials pertaining to glioblastoma and 1296 studies focused on Pembrolizumab actively seeking participants."

Answered by AI

Is there precedent for the efficacy of Pembrolizumab in other clinical research?

"The first research involving pembrolizumab commenced at Memorial Sloan Kettering Cancer Centre in 2004, and since then 1258 trials have been completed. At present, there are 1296 ongoing studies centered around this drug; with a large concentration of them taking place in New york City."

Answered by AI

To what degree does Pembrolizumab guarantee safety for its users?

"Clinical data suggests that Pembrolizumab is relatively safe, thus it was assigned a score of 2. This rating takes into account the fact that this medication has not yet been proven effective in Phase 3 clinical trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
David Reardon, MD 2018. "Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03661723.
~9 spots leftby Apr 2025
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