EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Purpose
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).
Condition
- Glioblastoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The participants in the study will be randomized in a ratio of 2:1 in favor of the treatment group to one of the following groups: Treatment Group - Optune concomitant with maintenance TMZ and pembrolizumab. Control Group - Optune concomitant with maintenance TMZ and placebo.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group |
|
|
|
Placebo Comparator Control Group |
|
Recruiting Locations
Mayo Clinic Hospital
Phoenix 5308655, Arizona 5551752 85054
Phoenix 5308655, Arizona 5551752 85054
University of Southern California
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663
Newport Beach 5376890, California 5332921 92663
Contact:
Simon Khagi
Simon Khagi
Stanford Cancer Institute
Palo Alto 5380748, California 5332921 94305
Palo Alto 5380748, California 5332921 94305
UF Health Neuromedicine
Gainesville 4156404, Florida 4155751 32608
Gainesville 4156404, Florida 4155751 32608
Mayo Clinic - Florida
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32224
Miami Cancer Institute
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536
Lexington 4297983, Kentucky 6254925 40536
University of Maryland
Baltimore 4347778, Maryland 4361885 21201
Baltimore 4347778, Maryland 4361885 21201
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Boston 4930956, Massachusetts 6254926 02111
Masonic Cancer Center, University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Minneapolis 5037649, Minnesota 5037779 55455
Mayo Clinic - Rochester
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Washington University
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
Northwell Health
Lake Success 5123853, New York 5128638 11042
Lake Success 5123853, New York 5128638 11042
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
Montefiore Medical Center- Montefiore Medical Park
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
The Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Pittsburgh 5206379, Pennsylvania 6254927 15232
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
Providence 5224151, Rhode Island 5224323 02903
The University of Texas
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Texas, MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Huntsman Cancer Institute, University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Salt Lake City 5780993, Utah 5549030 84112
Inova Schar Cancer Institute
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
Seattle 5809844, Washington 5815135 98122
More Details
- NCT ID
- NCT06556563
- Status
- Recruiting
- Sponsor
- NovoCure GmbH