EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (NCT06556563)
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).
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (102 Sites)
Showing the first 25 of 102 sites.
- 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
📞 Contact the Study Coordinator
Phone: (877) 678-8611
Email: clinicaltrials@novocure.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Glioblastoma
- Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma — Milwaukee, Wisconsin
- A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent. — New York, New York
- A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors — San Francisco, California
- Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma — Phoenix, Arizona
- A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma — Birmingham, Alabama
- Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma — Fairbanks, Alaska
Explore by condition: All Glioblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.