New combo tackles recurrent brain tumor: immunotherapy plus radiation before surgery
NCT ID NCT04977375
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether combining an immunotherapy drug (pembrolizumab) with targeted radiation before surgery is safe and feasible for people with recurrent glioblastoma, an aggressive brain cancer. Ten participants will receive the drug and radiation, then undergo standard surgery to remove the tumor. Researchers will monitor side effects and overall survival to see if this approach warrants further study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab (an immunotherapy drug that helps the immune system fight cancer)
- What this could lead to
- If this approach is safe and shows promise, it could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few effective therapies.
- What could go wrong
- This is a very early, small trial (only 10 participants) focused on safety, not effectiveness. The combination may cause serious side effects or fail to improve survival. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older * Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme * GBM recurrence or progression with planned standard of care surgical resection and repeat radiation * Tumor size less than 6 cm * ECOG performance status of 0-1 * Adequate laboratory values Exclusion Criteria: * Contraindication to additional radiation * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor * Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy * Severe hypersensitivity to pembrolizumab Complete inclusion/exclusion criteria are detailed in the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Other studies related to the condition(s) this trial covers.
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- Can a drug make radiation work better against aggressive brain tumors?