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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: Recruiting Phase 3 study of Glioblastoma, sponsored by NovoCure.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Overall survival (OS) is defined as the time from randomization to death due to any cause
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 741 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2029-04 |
| Phase | Phase 3 |
What NCT06556563 shows while recruiting
NCT06556563 is an interventional study that assigns participants to a tested intervention. The registered 741 participants enrollment target is mid-sized for trials with a published cap, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (606% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06556563's enrollment target sits among peer trials
741 6th of 199 higher than 194 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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