OncoMatch/Clinical Trials/NCT05235737

The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab

Is NCT05235737 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Pembrolizumab and Pembrolizumab for newly diagnosed glioblastoma.

Phase 4RecruitingMedical University of SilesiaNCT05235737Data as of May 2026

Treatment: Pembrolizumab · Pembrolizumab — To evaluate the short-term and longer-term safety, tolerability, and effectiveness of neoadjuvant and adjuvant Pembrolizumab on top of standard therapy (Stupp protocol) in patients with Glioblastoma Multiforme (GBM). Randomized comparison of safety, tolerability, and clinical efficacy of (1) neoadjuvant and adjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), (2) neoadjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), and (3) standard of care (Stupp protocol only, n=12 patients). Immuno-PET examination will be performed before and after surgery in all patients.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 wild-type

Required: IDH2 wild-type

Excluded: 1P19Q codeletion

Disease stage

Grade: 4

glioblastoma grade 4 IDH-wildtype

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic cancer treatment

Any previous systemic cancer treatment, including, but not limited to: Radiotherapy, Brachytherapy for brain tumor, Chemotherapy, Carmustine wafer treatment (Gliadel®), Any immune checkpoint inhibitor therapy or any anticancer vaccination

Lab requirements

Blood counts

Hemoglobin ≥ 9g/dL; Absolute Neutrophils Count (ANC) ≥1.5×10^9/L; White Blood Cells (WBC) count ≥3×10^9/L; Platelets (PTL) ≥ 100×10^9/L; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN

Kidney function

Serum creatinine (S-Cr) ≤ ULN; Glomerular Filtration Rate (GFR) ≥50mL/min; Albumin ≥ LLN

Liver function

AST/ALT ≤2.5×ULN; Bilirubin ≤ 1.5 ULN (except patients with documented Gilbert's Syndrome, who must present adequate level of direct bilirubin)

Adequate organ function (confirmed within 1 weeks before enrollment): ... see details

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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