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Active, not recruiting Phase 3

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

NCT06556563 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-02-03
Last updated
2026-11-06

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Optune® deviceTemozolomide →Pembrolizumab →Placebo

Optune® device: Optune® device delivering TTFields therapy at 200 kHz.

Temozolomide: Temozolomide per approved labeling.

Pembrolizumab: Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Placebo: Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. The participant (or legally acceptable representative) has provided documented informed consent for the study. 2. Be ≥ 18 years of age on day of providing informed consent. 3. Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification. 4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is not allowed. 5. Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy. 6. Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m\^2 daily x 5, Q28 days). 7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization. 8. Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable. Exclusion Criteria: 1. Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137). 2. Ongoing requirement for \>2 mg dexamethasone (or equivalent), due to intracranial mass effect. 3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. 4. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. 5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first study treatment. 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. 7. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 8. Early progressive disease after the end of TMZ/RT. If pseudo progression is suspected, additional imaging studies should be performed to rule out true progression. 9. Infratentorial or leptomeningeal disease.

Primary outcome measure(s)

  • Overall survival — 24 months
    Overall survival (OS) is defined as the time from randomization to death due to any cause

Trial sites (102)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona
University of Southern California Los Angeles California
Hoag Memorial Hospital Presbyterian Newport Beach California
Stanford Cancer Institute Palo Alto California
University of California San Francisco California
MedStar Georgetown University Hospital Washington D.C. District of Columbia
UF Health Neuromedicine Gainesville Florida
Mayo Clinic - Florida Jacksonville Florida
Miami Cancer Institute Miami Florida
Moffitt Cancer Center Tampa Florida
Northwestern Memorial Hospital Chicago Illinois
University of Kentucky Medical Center Lexington Kentucky
Norton Cancer Institute Louisville Kentucky
University of Maryland Baltimore Maryland
Tufts Medical Center Boston Massachusetts
Masonic Cancer Center, University of Minnesota Minneapolis Minnesota
Mayo Clinic - Rochester Rochester Minnesota
Washington University St Louis Missouri
Renown Regional Medical Center Reno Nevada
John Theurer Cancer Center/ Hackensack Meridian Health Hackensack New Jersey
Rutgers Cancer Institute of New Jersey University Hospital New Brunswick New Jersey
Northwell Health Lake Success New York
Columbia University Irving Medical Center New York New York
Montefiore Medical Center- Montefiore Medical Park The Bronx New York
Duke University Medical Center Durham North Carolina
University of Cincinnati Cancer Institute Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
The Cleveland Clinic Cleveland Ohio
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization Philadelphia Pennsylvania
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Rhode Island Hospital Providence Rhode Island
The University of Texas Houston Texas
University of Texas, MD Anderson Cancer Center Houston Texas
Huntsman Cancer Institute, University of Utah Salt Lake City Utah
Inova Schar Cancer Institute Fairfax Virginia
Swedish Medical Center Seattle Washington
Cross Cancer Institute Edmonton Alberta
Hamilton Health Sciences-Juravinski Cancer Centre Hamilton Ontario
The Ottawa Hospital Cancer Centre Ottawa Ontario
University Health Network - Princess Margaret Cancer Centre Toronto Ontario

+ 62 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06556563 on ClinicalTrials.gov ↗ ← All trials in the USA