EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- NCT06556563
- Lead Sponsor
- NovoCure GmbH
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 741
- 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 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group Optune® device - Treatment Group Pembrolizumab - Treatment Group Temozolomide - Control Group Optune® device - Control Group Temozolomide - Control Group Placebo -
- Primary Outcome Measures
Name Time Method Overall survival 24 months Overall survival (OS) is defined as the time from randomization to death due to any cause
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) per RANO assessed by investigator 24 months PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO assessed by investigator or death due to any cause, whichever occurs first.
Note: RANO = Response Assessment in Neuro-OncologyProgression-Free Survival (PFS) per mRANO assessed by investigator 24 months PFS is defined as the time interval, in months, between randomization and the first documented disease progression per mRANO assessed by investigator or death due to any cause, whichever occurs first.
Note: mRANO = Modified Radiographic Response Assessment in Neuro-Oncology
Trial Locations
- Locations (28)
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
🇬🇧Cambridge, United Kingdom
University of Southern California
🇺🇸Los Angeles, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
The Christie Hospital
🇬🇧Manchester, United Kingdom
Royal Marsden
🇬🇧Sutton, United Kingdom
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
UF Health Neuromedicine
🇺🇸Gainesville, Florida, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Huntsman Cancer Institute, University of Utah
🇺🇸Salt Lake City, Utah, United States
Institut Claudius Regaud
🇫🇷Toulouse, France
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
John Theurer Cancer Center/ Hackensack Meridian Health
🇺🇸Hackensack, New Jersey, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Groupe Hospitalier Pitie - Salpetriere
🇫🇷Paris, France
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
🇺🇸Philadelphia, Pennsylvania, United States
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Rabin Medical Center- Beilinson Hospital
🇮🇱Petah tikva, Israel
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States