Actively Recruiting
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-06
57
Participants Needed
10
Research Sites
259 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed grade II or III IDH-mutated glioma without CDKN2A/B deletion that has recurred after first-line therapy with maximal surgical resection
- Measurable disease by RANO criteria
- Stable corticosteroid dose for at least 4 weeks prior to baseline MRI, not exceeding 2 mg/day dexamethasone or equivalent
- Histologically confirmed IDH-wildtype glioma that has recurred after maximal surgical resection and radiation therapy
- Availability or plan for standard next-generation sequencing including IDH status
- Known or suspected harmful mutations in specified homologous recombination repair genes
- Written informed consent from patient or legally authorized representative
- Age 18 years or older
- ECOG performance status 0 or 1 (KPS ≥ 70) or lower KPS with prior approval
- Willingness and ability to comply with study visits, treatment, and lab tests
- Ability to swallow and retain oral medications
- Adequate organ function per study-defined laboratory values
- Recovery to grade 1 or better from prior therapy toxicities (except alopecia or grade 2 peripheral neuropathy)
- Specified minimum time elapsed since prior therapies including signaling pathway modulators, temozolomide, carboplatin, cisplatin, nitrosoureas, IDH inhibitors, and other anticancer drugs
- Ability to undergo contrast-enhanced MRI scans
- Clear evidence of tumor progression by MRI
- At least 12 weeks since prior radiotherapy
- Life expectancy greater than 12 weeks
- For women of childbearing potential: negative pregnancy test within 72 hours prior to allocation and agreement to use effective contraception during therapy and for 12 months after last dose
- Male participants must agree to use contraception during treatment and for at least 120 days after last dose and avoid sperm donation during this time
- Female participants must not be pregnant or breastfeeding and agree to contraception and breastfeeding restrictions as specified
- Hematological, renal, hepatic, and coagulation parameters within defined limits
- Stable corticosteroid dose for at least 5 days prior to baseline MRI
You will not qualify if you...
- Evidence of significant intracranial hemorrhage
- Use of any other investigational or standard anti-tumor therapy during study
- History of allergic reaction to study drugs or similar compounds unless manageable by pre-medication
- Serious medical conditions or uncontrolled illnesses that may interfere with study participation
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent daily within 7 days prior to first dose
- Active systemic fungal or viral infections including HIV, hepatitis B or C
- History of active tuberculosis
- Active infection requiring systemic therapy
- History or evidence of active non-infectious pneumonitis
- Use of strong CYP3A inhibitors or inducers as listed
- Positive pregnancy test within 72 hours prior to allocation for women of childbearing potential
- Presence of other active cancers except certain treated skin or cervical cancers
- Active autoimmune disease requiring systemic treatment within past 2 years
- Receipt of live vaccine within 30 days before study start (except inactivated seasonal flu vaccine)
- Concurrent treatment on another clinical trial except supportive care or nontherapeutic trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Hartford Healthcare Alliance (Data Collection Only)
Hartford, Connecticut, United States, 06102
Actively Recruiting
2
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
10
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
Research Team
L
Lauren Schaff, MD
CONTACT
T
Thomas Kaley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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