Phase 3Active, not recruiting
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).
- Sponsor
- NovoCure GmbH (Industry)
- Enrollment
- 741 planned
- Conditions
- Glioblastoma
- Interventions
- Optune® device; Temozolomide; Pembrolizumab; Placebo
- Ages
- adults, older adults
- Registry
- NCT06556563, CTIS2024-513550-30-00
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Overall survival
History
Primary completion expected
Last registry update
Started
Registered