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NCT06556563 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Glioblastoma, sponsored by NovoCure.

Recruiting
Registry status
Phase 3
Development phase
741
Enrollment target
20
Study locations

NCT06556563 is a Phase 3 study of Glioblastoma that is actively recruiting participants, run by NovoCure. The registered enrollment target is 741 participants, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (606% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT06556563, a Phase 3 study of Glioblastoma, is actively recruiting participants, sponsored by NovoCure.

RECRUITING
Registry status
Phase 3
Development phase
741 participants
Enrollment target
20
Study locations

Study 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).

Conditions Studied

Glioblastoma

Interventions

  • DRUG Pembrolizumab
  • DRUG Placebo
  • DRUG Temozolomide
  • DEVICE Optune® device

Study Locations (20)

Florida

  • UF Health Neuromedicine - Gainesville
  • Mayo Clinic - Florida - Jacksonville
  • Miami Cancer Institute - Miami
  • Moffitt Cancer Center - Tampa

California

  • University of Southern California - Los Angeles
  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Stanford Cancer Institute - Palo Alto

New York

  • Northwell Health - Lake Success
  • Columbia University Irving Medical Center - New York
  • Montefiore Medical Center- Montefiore Medical Park - The Bronx

Minnesota

  • Masonic Cancer Center, University of Minnesota - Minneapolis
  • Mayo Clinic - Rochester - Rochester

Arizona

  • Mayo Clinic Hospital - Phoenix

Illinois

  • Northwestern Memorial Hospital - Chicago

Kentucky

  • University of Kentucky Medical Center - Lexington

Maryland

  • University of Maryland - Baltimore

Trial Details

FieldValue
Enrollment Target 741 participants
Start Date 2025-02-03
Est. Completion 2029-04
Phase Phase 3

Sponsor

NovoCure

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06556563

The ClinicalTrials.gov registry entry for NCT06556563 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 741 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (606% higher). The listed sponsor is NovoCure, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT06556563 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, New York.

Frequently Asked Questions

What is clinical trial NCT06556563 about?

NCT06556563 is a clinical study titled "EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma". 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 Glioblas...

What is the current status of trial NCT06556563?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 741 participants. The study started on 2025-02-03. Estimated completion is 2029-04.

What conditions does trial NCT06556563 study?

This clinical trial studies the following conditions: Glioblastoma.

What interventions are being tested in trial NCT06556563?

The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Temozolomide (DRUG), Optune® device (DEVICE).

Who is sponsoring clinical trial NCT06556563?

This trial is sponsored by NovoCure, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06556563 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.