EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Optune® device — DEVICE
  Optune® device delivering TTFields therapy at 200 kHz.
• Temozolomide — DRUG
  Temozolomide per approved labeling.
• Pembrolizumab — DRUG
  Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
• Placebo — DRUG
  Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Study Details

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).

Key Dates

First listed

Aug 16, 2024

Start date

Feb 3, 2025

Status verified

Feb 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

741 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group
• Placebo Comparator: Control Group

Primary Outcome Measure

Overall survival [ Time Frame: 24 months ]

Central Contacts

• Uz Stammberger
  1-877-678-8611
  [email protected]

Locations (36)

Find similar trials in Phoenix, AZ

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