Status:
RECRUITING
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Lead Sponsor:
NovoCure GmbH
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pem...
Eligibility Criteria
Inclusion
- The participant (or legally acceptable representative) has provided documented informed consent for the study.
- Be ≥ 18 years of age on day of providing informed consent.
- Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
- 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.
- Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.
- Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m\^2 daily x 5, Q28 days).
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization.
- Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable.
Exclusion
- 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).
- Ongoing requirement for \>2 mg dexamethasone (or equivalent), due to intracranial mass effect.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- 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.
- 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.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- 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.
- Infratentorial or leptomeningeal disease.
Key Trial Info
Start Date :
February 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT06556563
Start Date
February 3 2025
End Date
April 1 2029
Last Update
December 1 2025
Active Locations (72)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
University of Southern California
Los Angeles, California, United States, 90033
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
4
Stanford Cancer Institute
Palo Alto, California, United States, 94305