OncoMatch

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.

Phase 2RecruitingL. Nicolas Gonzalez Castro, MD, PhDNCT05463848Data as of May 2026

Treatment: Pembrolizumab · Olaparib · TemozolomideThis 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 qualify

Extracted 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

Max 2 prior lines

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 →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify