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 Genders
- 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 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
University of Southern California
Los Angeles, California 90033
Los Angeles, California 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
Newport Beach, California 92663
Contact:
Simon Khagi
Simon Khagi
UF Health Neuromedicine
Gainesville, Florida 32608
Gainesville, Florida 32608
Miami Cancer Institute
Miami, Florida 33176
Miami, Florida 33176
University of Kentucky Medical Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Washington University
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Columbia University Irving Medical Center
New York, New York 10032
New York, New York 10032
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Swedish Medical Center
Seattle, Washington 98122
Seattle, Washington 98122
More Details
- NCT ID
- NCT06556563
- Status
- Recruiting
- Sponsor
- NovoCure GmbH