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Brain cancer patients get new hope: electric fields plus immunotherapy tested in major trial

NCT ID NCT06556563

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study tests whether adding an immunotherapy drug (pembrolizumab) to standard treatment (tumor-treating electric fields plus chemotherapy) helps people with newly diagnosed glioblastoma live longer. About 741 adults who have had surgery for glioblastoma will be randomly assigned to receive either the immunotherapy or a placebo, along with the standard therapy. The main goal is to see if the combination improves overall survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 741 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)

    ACTIVE_NOT_RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • CHUM

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    ACTIVE_NOT_RECRUITING

    Lausanne, 1005, Switzerland

  • Centre Hospitalier Universitaire de Lyon

    ACTIVE_NOT_RECRUITING

    Bron, 69500, France

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centrum Onkologii

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, 85-796, Poland

  • Chaim Sheba Medical Center

    ACTIVE_NOT_RECRUITING

    Ramat Gan, 5265601, Israel

  • Charing Cross Hospital

    ACTIVE_NOT_RECRUITING

    London, Greater London, W6 8RF, United Kingdom

  • Charité Campus Virchow-Klinikum

    ACTIVE_NOT_RECRUITING

    Berlin, 10117, Germany

  • Columbia University Irving Medical Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Duke University Medical Center

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    ACTIVE_NOT_RECRUITING

    Milan, 20133, Italy

  • Fujita Health University Hospital

    RECRUITING

    Toyoake-shi, Aichi-ken, 470-1192, Japan

  • Groupe Hospitalier Pitie - Salpetriere

    ACTIVE_NOT_RECRUITING

    Paris, 75013, France

  • Hamilton Health Sciences-Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Hoag Memorial Hospital Presbyterian

    ACTIVE_NOT_RECRUITING

    Newport Beach, California, 92663, United States

  • Hokkaido University Hospital

    RECRUITING

    Hokkaido, 060-8648, Japan

    Contact Email: •••••@•••••

  • Hopital Saint-Louis

    ACTIVE_NOT_RECRUITING

    Paris, 75010, France

  • Hopital de la Timone

    ACTIVE_NOT_RECRUITING

    Marseille, 13385, France

  • Hospital Universitari Vall d'Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politécnic La Fe

    ACTIVE_NOT_RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    ACTIVE_NOT_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Carlos

    ACTIVE_NOT_RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario La Paz

    ACTIVE_NOT_RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    ACTIVE_NOT_RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    ACTIVE_NOT_RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen de las Nieves

    ACTIVE_NOT_RECRUITING

    Granada, 18014, Spain

  • Hospital Universitario Virgen del Rocio

    ACTIVE_NOT_RECRUITING

    Seville, 41013, Spain

  • Huntsman Cancer Institute, University of Utah

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IRCCS Istituto Clinico Humanitas

    ACTIVE_NOT_RECRUITING

    Rozzano, 20089, Italy

  • Inova Schar Cancer Institute

    ACTIVE_NOT_RECRUITING

    Fairfax, Virginia, 22031, United States

  • Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)

    ACTIVE_NOT_RECRUITING

    Barcelona, 08908, Spain

  • Institut Claudius Regaud

    ACTIVE_NOT_RECRUITING

    Toulouse, 31059, France

  • John Theurer Cancer Center/ Hackensack Meridian Health

    ACTIVE_NOT_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kanazawa University Hospital

    RECRUITING

    Ishikawa, 920-8641, Japan

    Contact Email: •••••@•••••

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, 860-8556, Japan

    Contact Email: •••••@•••••

  • Kyorin University Hospital

    RECRUITING

    Mitaka, 181-8611, Japan

    Contact Email: •••••@•••••

  • Kyoto University Hospital

    RECRUITING

    Kyoto, 606-8507, Japan

    Contact Email: •••••@•••••

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, 812-8582, Japan

    Contact Email: •••••@•••••

  • Masonic Cancer Center, University of Minnesota

    ACTIVE_NOT_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Mayo Clinic - Florida

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Rochester

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85054, United States

  • MedStar Georgetown University Hospital

    ACTIVE_NOT_RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Miami Cancer Institute

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33176, United States

  • Moffitt Cancer Center

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center- Montefiore Medical Park

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10461, United States

  • Montreal Neurological Institute-Hospital, Clinical Research Unit

    RECRUITING

    Montreal, Quebec, H3A 2B4, Canada

  • Mount Vernon Cancer Centre

    ACTIVE_NOT_RECRUITING

    Northwood, Middlesex, HA6 2RN, United Kingdom

  • Nagoya University Hospital

    RECRUITING

    Nagoya, 466-8560, Japan

    Contact Email: •••••@•••••

  • Narodowy Instytut Onkologii

    ACTIVE_NOT_RECRUITING

    Gliwice, 44-102, Poland

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 104-0045, Japan

    Contact Email: •••••@•••••

  • Nemocnice Na Homolce

    ACTIVE_NOT_RECRUITING

    Prague, 150 30, Czechia

  • Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino

    ACTIVE_NOT_RECRUITING

    Torino, Torino, 10126, Italy

  • Northwell Health

    ACTIVE_NOT_RECRUITING

    Lake Success, New York, 11042, United States

  • Northwestern Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Norton Cancer Institute

    ACTIVE_NOT_RECRUITING

    Louisville, Kentucky, 40241, United States

  • Ospedale Bellaria

    ACTIVE_NOT_RECRUITING

    Bologna, 40139, Italy

  • Ospedale del Mare

    ACTIVE_NOT_RECRUITING

    Naples, 80147, Italy

  • Queen Elizabeth

    ACTIVE_NOT_RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Rabin Medical Center- Beilinson Hospital

    ACTIVE_NOT_RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    ACTIVE_NOT_RECRUITING

    Haifa, 3109601, Israel

  • Renown Regional Medical Center

    ACTIVE_NOT_RECRUITING

    Reno, Nevada, 89502, United States

  • Rhode Island Hospital

    ACTIVE_NOT_RECRUITING

    Providence, Rhode Island, 02903, United States

  • Royal Marsden

    ACTIVE_NOT_RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey University Hospital

    ACTIVE_NOT_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saitama Medical University International Medical Center

    RECRUITING

    Saitama, 350-1298, Japan

    Contact Email: •••••@•••••

  • Southampton General Hospital

    ACTIVE_NOT_RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Stanford Cancer Institute

    ACTIVE_NOT_RECRUITING

    Palo Alto, California, 94305, United States

  • Swedish Medical Center

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98122, United States

  • Tel-Aviv Sourasky Medical Center

    ACTIVE_NOT_RECRUITING

    Tel Aviv, 64239, Israel

  • The Christie Hospital

    ACTIVE_NOT_RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)

    ACTIVE_NOT_RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • The Cleveland Clinic

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Ottawa Hospital Cancer Centre

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The University of Texas

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tohoku University Hospital

    RECRUITING

    Sendai, 980-8574, Japan

    Contact Email: •••••@•••••

  • Tokai University Hospital

    RECRUITING

    Isehara, Kanagawa, 259-1193, Japan

  • Tufts Medical Center

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02111, United States

  • U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte

    ACTIVE_NOT_RECRUITING

    Siena, 53100, Italy

  • UF Health Neuromedicine

    ACTIVE_NOT_RECRUITING

    Gainesville, Florida, 32608, United States

  • UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS

    ACTIVE_NOT_RECRUITING

    Padova, 35128, Italy

  • UPMC Hillman Cancer Center

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University Health Network - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C1, Canada

  • University Hospital Basel Medical Oncology

    ACTIVE_NOT_RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Frankfurt

    ACTIVE_NOT_RECRUITING

    Frankfurt, 60528, Germany

  • University Hospital Zurich

    ACTIVE_NOT_RECRUITING

    Zurich, 8091, Switzerland

  • University Hospitals Cleveland Medical Center

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94143, United States

  • University of Cincinnati Cancer Institute

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Kentucky Medical Center

    ACTIVE_NOT_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Southern California

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90033, United States

  • University of Texas, MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Universitätsklinikum Essen

    ACTIVE_NOT_RECRUITING

    Essen, 45147, Germany

  • Velindre Cancer Centre

    ACTIVE_NOT_RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Washington University

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Western General Hospital

    ACTIVE_NOT_RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Weston Park Hospital

    ACTIVE_NOT_RECRUITING

    Sheffield, S10 2SJ, United Kingdom

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii

    ACTIVE_NOT_RECRUITING

    Lodz, 93-513, Poland

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