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).
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Mayo Clinic Hospital
RECRUITING
Phoenix
California
University of Southern California
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Stanford Cancer Institute
RECRUITING
Palo Alto
Florida
UF Health Neuromedicine
RECRUITING
Gainesville
Mayo Clinic - Florida
RECRUITING
Jacksonville
Miami Cancer Institute
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Kentucky
University of Kentucky Medical Center
RECRUITING
Lexington
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Maryland
University of Maryland
RECRUITING
Baltimore
Minnesota
Masonic Cancer Center, University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
Washington University
RECRUITING
St Louis
North Carolina
Duke University Medical Center
RECRUITING
Durham
New Jersey
John Theurer Cancer Center/ Hackensack Meridian Health
RECRUITING
Hackensack
New York
Northwell Health
RECRUITING
Lake Success
Columbia University Irving Medical Center
RECRUITING
New York
Montefiore Medical Center- Montefiore Medical Park
RECRUITING
The Bronx
Ohio
The Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Texas
The University of Texas
RECRUITING
Houston
University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
France
Centre Hospitalier Universitaire de Lyon
RECRUITING
Bron
Hopital de la Timone
RECRUITING
Marseille
Groupe Hospitalier Pitie - Salpetriere
RECRUITING
Paris
Hopital Saint-Louis
RECRUITING
Paris
Institut Claudius Regaud
RECRUITING
Toulouse
Germany
Universitätsklinikum Essen
RECRUITING
Essen
Israel
Rabin Medical Center- Beilinson Hospital
RECRUITING
Petah Tikva
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Hokkaido University Hospital
RECRUITING
Hokkaido
Kanazawa University Hospital
RECRUITING
Ishikawa
Kumamoto University Hospital
RECRUITING
Kumamoto
Kyoto University Hospital
RECRUITING
Kyoto
Kyorin University Hospital
RECRUITING
Mitaka
Nagoya University Hospital
RECRUITING
Nagoya
Saitama Medical University International Medical Center
RECRUITING
Saitama
Tohoku University Hospital
RECRUITING
Sendai
National Cancer Center Hospital
RECRUITING
Tokyo
Spain
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitari i Politécnic La Fe
RECRUITING
Valencia
Switzerland
University Hospital Zurich
RECRUITING
Zurich
United Kingdom
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)