Actively Recruiting
Surgical Pembro +/- Olaparib w TMZ for rGBM
Led by L. Nicolas Gonzalez Castro, MD, PhD · Updated on 2026-03-04
78
Participants Needed
4
Research Sites
227 weeks
Total Duration
On this page
Sponsors
L
L. Nicolas Gonzalez Castro, MD, PhD
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a combination therapy as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. The names of the study interventions involved in this study are/is: * Pembrolizumab * Olaparib * Temozolomide (Temodar)
CONDITIONS
Official Title
Surgical Pembro +/- Olaparib w TMZ for rGBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Able to follow dosing and visit schedules and record medication times accurately
- At least 18 years old on day of signing informed consent
- Women of childbearing potential eligible if not pregnant or breastfeeding
- Karnofsky Performance Status 70 or higher and ECOG Performance Status 0 or 1
- Able to swallow oral medications
- Histologically confirmed World Health Organization Grade IV IDH wildtype glioblastoma or variants
- At first or second relapse of glioblastoma
- Evidence of tumor progression by MRI within 14 days prior to registration
- Available sufficient tumor tissue from prior surgery for correlative studies
- Cohort 2 patients must have surgically resectable disease with > 2cm3 enhancing tissue
- At least 12 weeks since completion of radiation therapy unless confirmed progression
- Recovered to grade 0 or 1 or pre-treatment baseline from prior therapy toxic effects
- At least 4 weeks since prior surgical resection or 1 week since stereotactic biopsy
- Appropriate washout periods from prior therapies as specified
- Adequate organ function based on blood tests within 10 days prior to first dose
- No progressing additional malignancy interfering with study assessment
- Female participants not pregnant or breastfeeding and following contraceptive guidance
- Male participants agree to use contraception and refrain from sperm donation during and after treatment
You will not qualify if you...
- Prior evidence of 1p/19q co-deletion or IDH mutation
- Tumor primarily located in brainstem or spinal cord
- Presence of diffuse leptomeningeal or extracranial disease
- Prior treatment with PARP inhibitors, anti-VEGF agents, anti-PD-1/PD-L1/PD-L2 antibodies, or viral therapies for glioblastoma
- Use of colony-stimulating factors within 28 days prior to first dose
- Use of high dose systemic corticosteroids or systemic immunosuppressive treatments within specified timeframes
- Use of enzyme-inducing anti-epileptic drugs not stopped at least 14 days prior
- Use of strong CYP3A inhibitors or inducers not stopped at least 7 days prior
- Use of herbal medications or warfarin derivatives not stopped at least 7 days prior
- History of allergic reactions to study drugs, myelodysplastic syndrome, or significant tumor hemorrhage
- Uncontrolled illness including active infection, liver, kidney, lung, or psychiatric conditions
- Active infection requiring therapy or known viral infections like HIV or hepatitis
- Active autoimmune disease needing systemic treatment in past 2 years
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Receipt of live vaccine within 30 days prior to study treatment
- Diarrhea grade 2 or higher
- Active or recent significant cardiac disease
- Gastrointestinal disease affecting drug absorption
- Major surgery less than 4 weeks prior or not recovered from surgery effects
- Pregnancy or breastfeeding
- History of coagulopathy with bleeding risk or recent significant hemorrhage
- Known active non-infectious pneumonitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
L
Luis N Gonzalez Castro, MD
CONTACT
C
Christine J McCluskey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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