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Adding pembrolizumab to Optune and temozolomide for newly diagnosed glioblastoma

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

Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.

The trial team last updated this record on .

The short version

This study is testing whether adding a drug called pembrolizumab to standard tumor treating fields: A treatment that makes it harder for tumor cells to divide. It uses electric fields that switch back and forth. The fields come from pads on the scalp. A box you carry drives them. The box is often called Optune. See the glossary and chemotherapy helps people with a new glioblastoma: A glioma that is given grade 4. Grade 4 is the highest grade there is. The tumor grows fast. Treatment usually starts soon after it is found. It often means surgery, and then radiation and chemotherapy. See the glossary diagnosis.

Read our full plain-language summary

What the trial team says

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).

From the trial's own listing on ClinicalTrials.gov.

Key facts

Registry number
NCT06556563
Stage of testing
Phase 3
Conditions studied
Glioblastoma

Where it is running

This trial lists 102 sites.

How to use this

Talk to your care team first. They know your history and can tell you whether this trial is worth your time.

Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.

See the full listing on ClinicalTrials.gov

This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.