Brain cancer patients get new hope: electric fields plus immunotherapy tested in major trial
NCT ID NCT06556563
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 741 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
19 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
ACTIVE_NOT_RECRUITINGCambridge, CB2 0QQ, United Kingdom
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CHUM
RECRUITINGMontreal, Quebec, H2X 3E4, Canada
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Centre Hospitalier Universitaire Vaudois (CHUV)
ACTIVE_NOT_RECRUITINGLausanne, 1005, Switzerland
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Centre Hospitalier Universitaire de Lyon
ACTIVE_NOT_RECRUITINGBron, 69500, France
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Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)
RECRUITINGSherbrooke, Quebec, J1H 5N4, Canada
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Centrum Onkologii
ACTIVE_NOT_RECRUITINGBydgoszcz, 85-796, Poland
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Chaim Sheba Medical Center
ACTIVE_NOT_RECRUITINGRamat Gan, 5265601, Israel
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Charing Cross Hospital
ACTIVE_NOT_RECRUITINGLondon, Greater London, W6 8RF, United Kingdom
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Charité Campus Virchow-Klinikum
ACTIVE_NOT_RECRUITINGBerlin, 10117, Germany
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Columbia University Irving Medical Center
ACTIVE_NOT_RECRUITINGNew York, New York, 10032, United States
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Cross Cancer Institute
RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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Duke University Medical Center
ACTIVE_NOT_RECRUITINGDurham, North Carolina, 27710, United States
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Fondazione IRCCS Istituto Neurologico Carlo Besta
ACTIVE_NOT_RECRUITINGMilan, 20133, Italy
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Fujita Health University Hospital
RECRUITINGToyoake-shi, Aichi-ken, 470-1192, Japan
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Groupe Hospitalier Pitie - Salpetriere
ACTIVE_NOT_RECRUITINGParis, 75013, France
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Hamilton Health Sciences-Juravinski Cancer Centre
RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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Hoag Memorial Hospital Presbyterian
ACTIVE_NOT_RECRUITINGNewport Beach, California, 92663, United States
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Hokkaido University Hospital
RECRUITINGHokkaido, 060-8648, Japan
Contact Email: •••••@•••••
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Hopital Saint-Louis
ACTIVE_NOT_RECRUITINGParis, 75010, France
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Hopital de la Timone
ACTIVE_NOT_RECRUITINGMarseille, 13385, France
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Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITINGBarcelona, 08035, Spain
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Hospital Universitari i Politécnic La Fe
ACTIVE_NOT_RECRUITINGValencia, 46026, Spain
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Hospital Universitario 12 de Octubre
ACTIVE_NOT_RECRUITINGMadrid, 28041, Spain
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Hospital Universitario Clínico San Carlos
ACTIVE_NOT_RECRUITINGMadrid, Madrid, 28040, Spain
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Hospital Universitario La Paz
ACTIVE_NOT_RECRUITINGMadrid, 28046, Spain
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Hospital Universitario Ramón y Cajal
ACTIVE_NOT_RECRUITINGMadrid, 28034, Spain
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Hospital Universitario Reina Sofia
ACTIVE_NOT_RECRUITINGCórdoba, 14004, Spain
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Hospital Universitario Virgen de las Nieves
ACTIVE_NOT_RECRUITINGGranada, 18014, Spain
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Hospital Universitario Virgen del Rocio
ACTIVE_NOT_RECRUITINGSeville, 41013, Spain
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Huntsman Cancer Institute, University of Utah
ACTIVE_NOT_RECRUITINGSalt Lake City, Utah, 84112, United States
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IRCCS Istituto Clinico Humanitas
ACTIVE_NOT_RECRUITINGRozzano, 20089, Italy
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Inova Schar Cancer Institute
ACTIVE_NOT_RECRUITINGFairfax, Virginia, 22031, United States
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Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
ACTIVE_NOT_RECRUITINGBarcelona, 08908, Spain
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Institut Claudius Regaud
ACTIVE_NOT_RECRUITINGToulouse, 31059, France
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John Theurer Cancer Center/ Hackensack Meridian Health
ACTIVE_NOT_RECRUITINGHackensack, New Jersey, 07601, United States
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Kanazawa University Hospital
RECRUITINGIshikawa, 920-8641, Japan
Contact Email: •••••@•••••
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Kumamoto University Hospital
RECRUITINGKumamoto, 860-8556, Japan
Contact Email: •••••@•••••
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Kyorin University Hospital
RECRUITINGMitaka, 181-8611, Japan
Contact Email: •••••@•••••
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Kyoto University Hospital
RECRUITINGKyoto, 606-8507, Japan
Contact Email: •••••@•••••
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Kyushu University Hospital
RECRUITINGFukuoka, 812-8582, Japan
Contact Email: •••••@•••••
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Masonic Cancer Center, University of Minnesota
ACTIVE_NOT_RECRUITINGMinneapolis, Minnesota, 55455, United States
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Mayo Clinic - Florida
ACTIVE_NOT_RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic - Rochester
ACTIVE_NOT_RECRUITINGRochester, Minnesota, 55905, United States
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Mayo Clinic Hospital
ACTIVE_NOT_RECRUITINGPhoenix, Arizona, 85054, United States
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MedStar Georgetown University Hospital
ACTIVE_NOT_RECRUITINGWashington D.C., District of Columbia, 20007, United States
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Miami Cancer Institute
ACTIVE_NOT_RECRUITINGMiami, Florida, 33176, United States
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Moffitt Cancer Center
ACTIVE_NOT_RECRUITINGTampa, Florida, 33612, United States
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Montefiore Medical Center- Montefiore Medical Park
ACTIVE_NOT_RECRUITINGThe Bronx, New York, 10461, United States
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Montreal Neurological Institute-Hospital, Clinical Research Unit
RECRUITINGMontreal, Quebec, H3A 2B4, Canada
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Mount Vernon Cancer Centre
ACTIVE_NOT_RECRUITINGNorthwood, Middlesex, HA6 2RN, United Kingdom
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Nagoya University Hospital
RECRUITINGNagoya, 466-8560, Japan
Contact Email: •••••@•••••
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Narodowy Instytut Onkologii
ACTIVE_NOT_RECRUITINGGliwice, 44-102, Poland
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National Cancer Center Hospital
RECRUITINGTokyo, 104-0045, Japan
Contact Email: •••••@•••••
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Nemocnice Na Homolce
ACTIVE_NOT_RECRUITINGPrague, 150 30, Czechia
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Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino
ACTIVE_NOT_RECRUITINGTorino, Torino, 10126, Italy
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Northwell Health
ACTIVE_NOT_RECRUITINGLake Success, New York, 11042, United States
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Northwestern Memorial Hospital
ACTIVE_NOT_RECRUITINGChicago, Illinois, 60611, United States
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Norton Cancer Institute
ACTIVE_NOT_RECRUITINGLouisville, Kentucky, 40241, United States
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Ospedale Bellaria
ACTIVE_NOT_RECRUITINGBologna, 40139, Italy
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Ospedale del Mare
ACTIVE_NOT_RECRUITINGNaples, 80147, Italy
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Queen Elizabeth
ACTIVE_NOT_RECRUITINGBirmingham, B15 2TH, United Kingdom
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Rabin Medical Center- Beilinson Hospital
ACTIVE_NOT_RECRUITINGPetah Tikva, 4941492, Israel
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Rambam Medical Center
ACTIVE_NOT_RECRUITINGHaifa, 3109601, Israel
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Renown Regional Medical Center
ACTIVE_NOT_RECRUITINGReno, Nevada, 89502, United States
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Rhode Island Hospital
ACTIVE_NOT_RECRUITINGProvidence, Rhode Island, 02903, United States
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Royal Marsden
ACTIVE_NOT_RECRUITINGSutton, SM2 5PT, United Kingdom
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Rutgers Cancer Institute of New Jersey University Hospital
ACTIVE_NOT_RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Saitama Medical University International Medical Center
RECRUITINGSaitama, 350-1298, Japan
Contact Email: •••••@•••••
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Southampton General Hospital
ACTIVE_NOT_RECRUITINGSouthampton, SO16 6YD, United Kingdom
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Stanford Cancer Institute
ACTIVE_NOT_RECRUITINGPalo Alto, California, 94305, United States
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Swedish Medical Center
ACTIVE_NOT_RECRUITINGSeattle, Washington, 98122, United States
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Tel-Aviv Sourasky Medical Center
ACTIVE_NOT_RECRUITINGTel Aviv, 64239, Israel
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The Christie Hospital
ACTIVE_NOT_RECRUITINGManchester, M20 4BX, United Kingdom
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The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)
ACTIVE_NOT_RECRUITINGLiverpool, L7 8YA, United Kingdom
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The Cleveland Clinic
ACTIVE_NOT_RECRUITINGCleveland, Ohio, 44195, United States
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The Ottawa Hospital Cancer Centre
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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The University of Texas
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
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Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
ACTIVE_NOT_RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Tohoku University Hospital
RECRUITINGSendai, 980-8574, Japan
Contact Email: •••••@•••••
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Tokai University Hospital
RECRUITINGIsehara, Kanagawa, 259-1193, Japan
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Tufts Medical Center
ACTIVE_NOT_RECRUITINGBoston, Massachusetts, 02111, United States
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U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte
ACTIVE_NOT_RECRUITINGSiena, 53100, Italy
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UF Health Neuromedicine
ACTIVE_NOT_RECRUITINGGainesville, Florida, 32608, United States
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UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
ACTIVE_NOT_RECRUITINGPadova, 35128, Italy
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UPMC Hillman Cancer Center
ACTIVE_NOT_RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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University Health Network - Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2C1, Canada
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University Hospital Basel Medical Oncology
ACTIVE_NOT_RECRUITINGBasel, 4031, Switzerland
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University Hospital Frankfurt
ACTIVE_NOT_RECRUITINGFrankfurt, 60528, Germany
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University Hospital Zurich
ACTIVE_NOT_RECRUITINGZurich, 8091, Switzerland
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University Hospitals Cleveland Medical Center
ACTIVE_NOT_RECRUITINGCleveland, Ohio, 44106, United States
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University of California
ACTIVE_NOT_RECRUITINGSan Francisco, California, 94143, United States
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University of Cincinnati Cancer Institute
ACTIVE_NOT_RECRUITINGCincinnati, Ohio, 45219, United States
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University of Kentucky Medical Center
ACTIVE_NOT_RECRUITINGLexington, Kentucky, 40536, United States
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University of Maryland
ACTIVE_NOT_RECRUITINGBaltimore, Maryland, 21201, United States
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University of Southern California
ACTIVE_NOT_RECRUITINGLos Angeles, California, 90033, United States
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University of Texas, MD Anderson Cancer Center
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
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Universitätsklinikum Essen
ACTIVE_NOT_RECRUITINGEssen, 45147, Germany
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Velindre Cancer Centre
ACTIVE_NOT_RECRUITINGCardiff, CF14 2TL, United Kingdom
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Washington University
ACTIVE_NOT_RECRUITINGSt Louis, Missouri, 63110, United States
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Western General Hospital
ACTIVE_NOT_RECRUITINGEdinburgh, EH4 2XU, United Kingdom
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Weston Park Hospital
ACTIVE_NOT_RECRUITINGSheffield, S10 2SJ, United Kingdom
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Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii
ACTIVE_NOT_RECRUITINGLodz, 93-513, Poland
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