OncoMatch/Clinical Trials/NCT06556563
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Is NCT06556563 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Optune® device and Temozolomide for glioblastoma.
Treatment: Optune® device · Temozolomide · Pembrolizumab — This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: radiation therapy — adjuvant
Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy)
Must have received: cytotoxic chemotherapy (temozolomide) — concomitant
concomitant TMZ chemotherapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital · Phoenix, Arizona
- University of Southern California · Los Angeles, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Stanford Cancer Institute · Palo Alto, California
- UF Health Neuromedicine · Gainesville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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