OncoMatch/Clinical Trials/NCT05463848
Surgical Pembro +/- Olaparib w TMZ for rGBM
Is NCT05463848 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Olaparib for glioblastoma.
Treatment: Pembrolizumab · Olaparib · Temozolomide — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
IDH wildtype glioblastoma by IDHR132H immunohistochemistry
Required: IDH2 wild-type
IDH wildtype glioblastoma by IDHR132H immunohistochemistry
Excluded: 1P/19Q co-deletion
Prior evidence of 1p/19q co-deletion
Allowed: EGFR amplification
IDH wildtype diffuse glioma with molecularly features of glioblastoma (EGFR amplification, TERT promoter mutation, or concurrent gain of Chromosome 7 and loss of Chromosome 10)
Allowed: TERT promoter mutation
IDH wildtype diffuse glioma with molecularly features of glioblastoma (EGFR amplification, TERT promoter mutation, or concurrent gain of Chromosome 7 and loss of Chromosome 10)
Prior therapy
Must have received: radiation therapy — initial therapy
First relapse is defined as progression following initial therapy
Cannot have received: PARP inhibitor (olaparib, niraparib)
Participants who have received prior treatment with a PARP inhibitor (e.g. olaparib, niraparib)
Cannot have received: anti-VEGF targeted agent (bevacizumab, cediranib, aflibercept, vandetanib, cabozantinib, sunitinib)
Participants who have received anti-VEGF targeted agents (e.g. bevacizumab, cediranib, aflibercept, vandetanib, cabozantinib, sunitinib etc.)
Cannot have received: anti-PD-1 therapy
Participants who have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: viral therapy or vaccine for glioblastoma
Participants who have received prior viral therapy or vaccines for glioblastoma
Lab requirements
Blood counts
Leukocytes ≥ 3,000/µL; Absolute neutrophil count (ANC) ≥ 1,500/µL; Platelet count ≥ 100,000/µL; Absolute Lymphocyte Count ≥ 500/µL; Hemoglobin ≥ 9.0 g/dL
Kidney function
Serum creatinine ≤ 1.5 x institution's ULN or calculated 24-hour creatinine clearance > 50 mL/min
Liver function
AST (SGOT) and ALT (SGPT) ≤ 2.5 x institution's ULN (or ≤ 5 X institutional ULN for subjects with Gilberts syndrome); Serum bilirubin ≤ 1.5 x institution's ULN or direct bilirubin ≤ institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN.
Cardiac function
QTc prolongation >500 ms (calculated via the Fridericia formula); exclusion for significant cardiac disease or dysfunction as detailed in criteria
All screening laboratory tests should be performed within 10 days prior to the first dose of the study intervention. See full criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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