RecruitingGlioma
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This study will test the safety and effectiveness of a combination of pembrolizumab, olaparib, and temozolomide to see how well these drugs work when given together in people with a glioma that either did not respond to previous treatment or came back after treatment.
Sponsor: Memorial Sloan Kettering Cancer Center
You may qualify if…
- ✓ Safety Lead-In and Cohort A specific inclusion:
- ✓ 1. Histologically confirmed grade II or III IDH-mutated glioma (absence of known CDKN2A/B deletion) that has recurred after first line therapy (consisting of at least maximum feasible surgical resection). There is no limit on the number of prior therapies or types of therapies patients can have received.
- ✓ 2. Measurable disease by RANO criteria
- ✓ 3. Stable dose of corticosteroids for ≥ 4 weeks prior to baseline MRI. Steroid dose not to exceed 2mg/day dexamethasone (or equivalent).
- ✓ Cohort B specific inclusion:
- ✓ 1. Histologically confirmed IDH-wildtype glioma that has recurred following therapy (consisting of at least maximum feasible surgical resection and radiation therapy).
- ✓ 2. Standard of care next generation sequencing via a CLIA certified platform must be available or planned and at a minimum include IDH status.
- ✓ 3. Patient with known or suspected deleterious mutations in at least 1 of the specified 15 genes involved in homologous recombination repair (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L)
You may not qualify if…
- ✕ 1. No limit on number of prior therapies
- ✕ 2. Evidence of significant intracranial hemorrhage
- ✕ 3. No other investigational or standard anti-tumor therapy allowed
- ✕ 4. Patients must not have a known history of allergic reaction attributed to study drugs or compounds of similar chemical or biologic composition unless allergic reaction was managed by pre-medication.
- ✕ 5. Patients must not have a serious pre-existing medical condition or uncontrolled intercurrent illness that would preclude participation in this study (for example, uncontrolled ventricular arrhythmia, interstitial lung disease, severe dyspnea at rest of requiring oxygen therapy, history of major surgical resection involving the stomach or bowel, or pre-existing Crohn's disease or ulcerative colitis or other autoimmune disease,) or psychiatric illness/social situations that would limit compliance with study requirements
- ✕ 6. Patients must not have a diagnosis of immunodeficiency or be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- ✕ 7. Patients must not have an active systemic fungal and/or known viral infection (for example human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies).
- ✕ 8. Patients must not have a history of active tuberculosis.
Where it's recruiting
Connecticut
Hartford
Florida
Miami
New Jersey
Basking Ridge · Middletown · Montvale
New York
Commack · Harrison · New York · Uniondale
Pennsylvania
Allentown
Source: ClinicalTrials.gov · NCT05188508 · last updated 2026-07-22