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Clinical Trials in the USA / NCT06556563
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
Sponsor
NovoCure GmbH
Phase
Phase 3
Started
2025-02-03
Last updated
2026-08-19

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Optune® deviceTemozolomidePembrolizumabPlacebo

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)

Trial sites (102)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Active Not Recruiting
University of Southern California Los Angeles California Active Not Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Active Not Recruiting
Stanford Cancer Institute Palo Alto California Active Not Recruiting
University of California San Francisco California Active Not Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Active Not Recruiting
UF Health Neuromedicine Gainesville Florida Active Not Recruiting
Mayo Clinic - Florida Jacksonville Florida Active Not Recruiting
Miami Cancer Institute Miami Florida Active Not Recruiting
Moffitt Cancer Center Tampa Florida Active Not Recruiting
Northwestern Memorial Hospital Chicago Illinois Active Not Recruiting
University of Kentucky Medical Center Lexington Kentucky Active Not Recruiting
Norton Cancer Institute Louisville Kentucky Active Not Recruiting
University of Maryland Baltimore Maryland Active Not Recruiting
Tufts Medical Center Boston Massachusetts Active Not Recruiting
Masonic Cancer Center, University of Minnesota Minneapolis Minnesota Active Not Recruiting
Mayo Clinic - Rochester Rochester Minnesota Active Not Recruiting
Washington University St Louis Missouri Active Not Recruiting
Renown Regional Medical Center Reno Nevada Active Not Recruiting
John Theurer Cancer Center/ Hackensack Meridian Health Hackensack New Jersey Active Not Recruiting
Rutgers Cancer Institute of New Jersey University Hospital New Brunswick New Jersey Active Not Recruiting
Northwell Health Lake Success New York Active Not Recruiting
Columbia University Irving Medical Center New York New York Active Not Recruiting
Montefiore Medical Center- Montefiore Medical Park The Bronx New York Active Not Recruiting
Duke University Medical Center Durham North Carolina Active Not Recruiting
University of Cincinnati Cancer Institute Cincinnati Ohio Active Not Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Active Not Recruiting
The Cleveland Clinic Cleveland Ohio Active Not Recruiting
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization Philadelphia Pennsylvania Active Not Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Active Not Recruiting
Rhode Island Hospital Providence Rhode Island Active Not Recruiting
The University of Texas Houston Texas Active Not Recruiting
University of Texas, MD Anderson Cancer Center Houston Texas Active Not Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Active Not Recruiting
Inova Schar Cancer Institute Fairfax Virginia Active Not Recruiting
Swedish Medical Center Seattle Washington Active Not Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre Hamilton Ontario Recruiting
The Ottawa Hospital Cancer Centre Ottawa Ontario Recruiting
University Health Network - Princess Margaret Cancer Centre Toronto Ontario Recruiting

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

On this site

📄 Keytruda (pembrolizumab) drug profile →

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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