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Pembrolizumab, Olaparib, and Temozolomide for Glioma

This study is testing a combination of three drugs: pembrolizumab, olaparib, and temozolomide. It's for people with glioma (a type of brain tumor) that has come back or didn't respond to earlier treatments. The goal is to see how safe and effective these drugs are when given together. You might be able to join if you have a specific type of glioma (IDH-mutated grade II or III) that has returned after surgery. The researchers will be looking at how many people respond to the treatment over a period of up to two years. The study is currently unclear about its recruitment status.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 57 participants.
What's involved
You would receive pembrolizumab every 21 days throughout the trial. Olaparib and temozolomide would be taken orally for 7 days each cycle, starting from cycle 3 and continuing through cycle 11.
Compensation
Not stated in the trial record.
Follow-up
The study will measure overall response rate for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05188508

Pembrolizumab, Olaparib, and Temozolomide for People With Glioma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~57 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PembrolizumabOlaparib and Temozolomide

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
overall response rate (Cohort A)
Measured over up to 2 years

Conditions

Glioma

Explore related trials

GliomaCDKN2A GeneHomologous Recombination Repair GeneIDH1 wt Allele

Where it's being run

10 sites across 5 states
New York4
New Jersey3
Connecticut1
Florida1
Pennsylvania1

Study leadership

  • Lauren Schaff, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Lauren Schaff, MD
[email protected]
212-610-0485
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hematological Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \<1.5 × institutional ULN
Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

What this trial measures

  • overall response rate (Cohort A)up to 2 years

    The response will be determined as outlined in the RANO and iRANO.