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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06556563
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NovoCure GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: Treatment Group

Placebo Comparator: Control Group

Interventions

Device: - Optune® device

Optune® device delivering TTFields therapy at 200 kHz.

Drug: - Temozolomide

Temozolomide per approved labeling.

Drug: - Pembrolizumab

Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Drug: - Placebo

Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Southern California, Los Angeles, California

Status

Recruiting

Address

University of Southern California

Los Angeles, California, 90033

Site Contact

Frances Chow

[email protected]

323-865-3300

Hoag Memorial Hospital Presbyterian, Newport Beach, California

Status

Recruiting

Address

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Site Contact

Simon Khagi

[email protected]

1-877-678-8611

UF Health Neuromedicine, Gainesville, Florida

Status

Recruiting

Address

UF Health Neuromedicine

Gainesville, Florida, 32608

Site Contact

Ashley Ghiaseddin

[email protected]

1-877-678-8611

Miami Cancer Institute, Miami, Florida

Status

Recruiting

Address

Miami Cancer Institute

Miami, Florida, 33176

Site Contact

Yazmin Odia

[email protected]

305-595-2141

University of Kentucky Medical Center, Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky Medical Center

Lexington, Kentucky, 40536

Site Contact

John Villano

[email protected]

312-996-6651

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63110

Site Contact

Omar Butt

[email protected]

314-747-4241

New York, New York

Status

Recruiting

Address

Columbia University Irving Medical Center

New York, New York, 10032

Site Contact

Fabio Iwamoto

[email protected]

212-342-0571

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Site Contact

Herbert Newton

[email protected]

216-368-5693

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Site Contact

Jan Drappatz

[email protected]

412-864-7791

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Site Contact

Eric Wong

[email protected]

401-444-4184

Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

Site Contact

Howard Colman

[email protected]

801-585-0255

Inova Schar Cancer Institute, Fairfax, Virginia

Status

Recruiting

Address

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

Site Contact

Adam Cohen

[email protected]

571-472-4724

Swedish Medical Center, Seattle, Washington

Status

Recruiting

Address

Swedish Medical Center

Seattle, Washington, 98122

Site Contact

Mark Loreen

[email protected]

206-320-7121

International Sites

Hidaka-shi, Saitama-Ken, Japan

Status

Recruiting

Address

Saitama Medical University International Medical Center

Hidaka-shi, Saitama-Ken, 350-1298

Site Contact

Kazuhiko Mishima

[email protected]

+81429844111

Nagoya University Hospital, Aichi, Japan

Status

Recruiting

Address

Nagoya University Hospital

Aichi, , 466-8560

Site Contact

Ryuta Saito

[email protected]

+81527412111

Kyushu University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Kyushu University Hospital

Fukuoka, , 812-8582

Site Contact

Koji Yoshimoto

[email protected]

+81926411151

Kanazawa University Hospital, Ishikawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Ishikawa, , 920-8641

Site Contact

Mitsutoshi Nakada

[email protected]

+81762652000

Kumamoto University Hospital, Kumamoto, Japan

Status

Recruiting

Address

Kumamoto University Hospital

Kumamoto, , 860-8556

Site Contact

Akitake Mukasa

[email protected]

+81963442111

Kyoto University Hospital, Kyoto-shi, Japan

Status

Recruiting

Address

Kyoto University Hospital

Kyoto-shi, ,

Site Contact

Yoshiki Arakawa

[email protected]

+81757513459

Hokkaido University Hospital, Sapporo, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Sapporo, , 060-8648

Site Contact

Shigeru Yamaguchi

[email protected]

81117161161

Tohoku University Hospital, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Sendai, , 980-8574

Site Contact

Hidenori Endo

[email protected]

+81227177000

National Cancer Center Hospital, Tokyo, Japan

Status

Recruiting

Address

National Cancer Center Hospital

Tokyo, , 104-0045

Site Contact

Yoshitaka Narita

[email protected]

+81335422511

The Christie Hospital, Manchester, United Kingdom

Status

Recruiting

Address

The Christie Hospital

Manchester, , M20 4BX

Site Contact

Monika Burek

[email protected]

+44-161-918-2175