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

ClinicalTrials.gov ID: NCT06556563

Public ClinicalTrials.gov record NCT06556563. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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).

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT06556563
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: NovoCure GmbH; Industry
Enrollment: 741 participants

Conditions and interventions

Conditions

Glioblastoma

Interventions

Device · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 2, 2025
Primary completion: Mar 31, 2029
Completion: Mar 31, 2029
Last update posted: Aug 18, 2026

2025 – 2029

United States locations

U.S. sites: 36
U.S. states: 21
U.S. cities: 34

Facility	City	State	ZIP	Site status
Mayo Clinic Hospital	Phoenix	Arizona	85054	Active, not recruiting
University of Southern California	Los Angeles	California	90033	Active, not recruiting
Hoag Memorial Hospital Presbyterian	Newport Beach	California	92663	Active, not recruiting
Stanford Cancer Institute	Palo Alto	California	94305	Active, not recruiting
University of California	San Francisco	California	94143	Active, not recruiting
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia	20007	Active, not recruiting
UF Health Neuromedicine	Gainesville	Florida	32608	Active, not recruiting
Mayo Clinic - Florida	Jacksonville	Florida	32224	Active, not recruiting
Miami Cancer Institute	Miami	Florida	33176	Active, not recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Active, not recruiting
Northwestern Memorial Hospital	Chicago	Illinois	60611	Active, not recruiting
University of Kentucky Medical Center	Lexington	Kentucky	40536	Active, not recruiting
Norton Cancer Institute	Louisville	Kentucky	40241	Active, not recruiting
University of Maryland	Baltimore	Maryland	21201	Active, not recruiting
Tufts Medical Center	Boston	Massachusetts	02111	Active, not recruiting
Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	55455	Active, not recruiting
Mayo Clinic - Rochester	Rochester	Minnesota	55905	Active, not recruiting
Washington University	St Louis	Missouri	63110	Active, not recruiting
Renown Regional Medical Center	Reno	Nevada	89502	Active, not recruiting
John Theurer Cancer Center/ Hackensack Meridian Health	Hackensack	New Jersey	07601	Active, not recruiting
Rutgers Cancer Institute of New Jersey University Hospital	New Brunswick	New Jersey	08901	Active, not recruiting
Northwell Health	Lake Success	New York	11042	Active, not recruiting
Columbia University Irving Medical Center	New York	New York	10032	Active, not recruiting
Montefiore Medical Center- Montefiore Medical Park	The Bronx	New York	10461	Active, not recruiting
Duke University Medical Center	Durham	North Carolina	27710	Active, not recruiting
University of Cincinnati Cancer Institute	Cincinnati	Ohio	45219	Active, not recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	44106	Active, not recruiting
The Cleveland Clinic	Cleveland	Ohio	44195	Active, not recruiting
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization	Philadelphia	Pennsylvania	19107	Active, not recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Active, not recruiting
Rhode Island Hospital	Providence	Rhode Island	02903	Active, not recruiting
The University of Texas	Houston	Texas	77030	Active, not recruiting
University of Texas, MD Anderson Cancer Center	Houston	Texas	77030	Active, not recruiting
Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah	84112	Active, not recruiting
Inova Schar Cancer Institute	Fairfax	Virginia	22031	Active, not recruiting
Swedish Medical Center	Seattle	Washington	98122	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 66 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06556563, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 18, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06556563 live on ClinicalTrials.gov.

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