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).

Summary

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).

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Optune® device

  Optune® device delivering TTFields therapy at 200 kHz.

• Drug
  Temozolomide

  Temozolomide per approved labeling.

• Drug
  Pembrolizumab

  Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

• Drug
  Placebo

  Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Locations (93)