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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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

ArmDescriptionAssigned Intervention
Experimental
Treatment Group
  • Device: Optune® device
    Optune® device delivering TTFields therapy at 200 kHz.
    Other names:
    • TTFields
  • Drug: Temozolomide
    Temozolomide per approved labeling.
  • Drug: Pembrolizumab
    Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Placebo Comparator
Control Group
  • Device: Optune® device
    Optune® device delivering TTFields therapy at 200 kHz.
    Other names:
    • TTFields
  • Drug: Temozolomide
    Temozolomide per approved labeling.
  • Drug: Placebo
    Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Recruiting Locations

Mayo Clinic Hospital
Phoenix 5308655, Arizona 5551752 85054
Contact:
Alyx Porter
480-342-2000
Porter.alyx@mayo.edu

University of Southern California
Los Angeles 5368361, California 5332921 90033
Contact:
Frances Chow
323-865-3300
frances.chow@med.usc.edu

Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663
Contact:
Simon Khagi

Stanford Cancer Institute
Palo Alto 5380748, California 5332921 94305
Contact:
Lawrence Recht
650-498-4686
LRrecht@Stanford.edu

UF Health Neuromedicine
Gainesville 4156404, Florida 4155751 32608
Contact:
Ashley Ghiaseddin
ashley.ghiaseddin@neurosurgery.ufl.edu

Mayo Clinic - Florida
Jacksonville 4160021, Florida 4155751 32224
Contact:
Wendy Sherman
904-953-2000
Sherman.Wendy@mayo.edu

Miami Cancer Institute
Miami 4164138, Florida 4155751 33176
Contact:
Yazmin Odia
305-595-2141
yazmino@baptisthealth.net

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
Patrick Grogan
507-250-5032
patrick.grogan@moffitt.org

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Contact:
Roger Stupp
312-926-9268
Roger.stupp@northwestern.edu

University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536
Contact:
John Villano
312-996-6651
jlvillano@uky.edu

University of Maryland
Baltimore 4347778, Maryland 4361885 21201
Contact:
Haroon Ahmad
410-706-5875
hahmad@som.umaryland.edu

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Suriya Jeyapalan
617-636-2694
sjeyapalan@tuftsmedicalcenter.org

Masonic Cancer Center, University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Elizabeth Neil
(612)-625-5317
neile@umn.edu

Mayo Clinic - Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Ugur Sener
507-284-2511
sener.ugur@mayo.edu

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Omar Butt
314-747-4241
omarhbutt@wustl.edu

John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Deric Park
(551)-996-5230
Deric.park@hmhn.org

Northwell Health
Lake Success 5123853, New York 5128638 11042
Contact:
Samuel Singer
(516)-941-1260
ssinger3@northwell.edu

Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
Contact:
Fabio Iwamoto
212-342-0571
fi2146@cumc.columbia.edu

Montefiore Medical Center- Montefiore Medical Park
The Bronx 5110266, New York 5128638 10461
Contact:
Adilia Hormigo
718-430-2399
adilia.hormigo@einsteinmed.edu

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Contact:
Katherine Peters
(919) 684-3914
Katherine.peters@duke.edu

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Herbert Newton
216-368-5693
Herbert.Newton@UHhospitals.org

The Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Mark Malkin
216-445-8380
malkinm@ccf.org

Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Iyad Alnahhas
215-955-7000
iyad.alnahhas@jefferson.edu

UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Jan Drappatz
412-864-7791
drappatzj@upmc.edu

Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
Contact:
Eric Wong
401-444-4184
EWong1@LifeSpan.org

The University of Texas
Houston 4699066, Texas 4736286 77030
Contact:
Jay Jiguang Zhu
713-486-8000
Jay.Jiguang.Zhu@uth.tmc.edu

University of Texas, MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Chirag Patel
713-792-0778
CBPatel@mdanderson.org

Huntsman Cancer Institute, University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Contact:
Howard Colman
801-585-0255
Howard.Colman@hci.utah.edu

Inova Schar Cancer Institute
Fairfax 4758023, Virginia 6254928 22031
Contact:
Adam Cohen
571-472-4724
adam.cohen@inova.org

Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
Contact:
Mark Loreen
2063207121
alipi.bonm@swedish.org

More Details

NCT ID
NCT06556563
Status
Recruiting
Sponsor
NovoCure GmbH

Study Contact

Uz Stammberger
1-877-678-8611
clinicaltrials@novocure.com

Notice

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