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Massive brain cancer trial aims to find better treatments

NCT ID NCT03970447

Disease control Sponsor: Global Coalition for Adaptive Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 31, 2026 · Updated 6 times

Summary

This large international trial is testing several different drugs, including temozolomide, lomustine, regorafenib, and paxalisib, in people with newly diagnosed or recurrent glioblastoma, an aggressive brain cancer. The study uses an adaptive design, meaning it can quickly drop ineffective treatments and focus on promising ones. The main goal is to see if these drugs help patients live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Temozolomide, Lomustine, Regorafenib, Paxalisib, and radiation therapy
What this could lead to
If successful, this trial could identify more effective drug combinations for glioblastoma, potentially extending survival and improving quality of life for patients.
What could go wrong
This is an early-phase adaptive trial testing multiple drugs, so many may not prove effective. Glioblastoma is a very aggressive cancer, and even promising treatments often fail in larger studies.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 2,250 people

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

Started

Jul 2019

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Newly Diagnosed Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \[IHC\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained. * Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization. * Availability of tumor tissue representative of GBM from definitive surgery or biopsy. Recurrent Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \[IHC\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT). * Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria. * Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression. * Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization. * Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed. Newly Diagnosed Exclusion Criteria: * Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial. * Extensive leptomeningeal disease. * QTc \> 470 msec * History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Recurrent Exclusion Criteria: * Early disease progression prior to 3 months (12 weeks) from the completion of RT. * More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.) * Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent. * Any prior treatment with prolifeprospan 20 with carmustine wafer. * Any prior treatment with an intracerebral agent. * Receiving additional, concurrent, active therapy for GBM outside of the trial * Extensive leptomeningeal disease. * QTc \> 470 msec * History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

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Conditions

The condition(s) this trial relates to.

glioblastoma Recurrence

As listed by the trial registrant

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

Glioblastoma

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

    40 sites in 6 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

Locations

  • Allegheny General Hospital

    COMPLETED

    Pittsburgh, Pennsylvania, 15212, United States

  • Allina Health Systems/Abbott Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

    Contact Email: •••••@•••••

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer

    RECRUITING

    Bron, 69677, France

  • Centre Hospitalier Universitaire Vaudois Lausanne

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Center of Wake Forest*

    RECRUITING

    Winston-Salem, North Carolina, 272157, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Dr. Senckenbergisches Institut für Neuroonkologie

    RECRUITING

    Frankfurt, 60528, Germany

  • Duke University Medical Center

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Froedtert Hospital/Medical College of Wisconsin

    ACTIVE_NOT_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Henry Ford Health System

    COMPLETED

    Detroit, Michigan, 48202, United States

  • Hopital Piti-Salpetriere

    RECRUITING

    Paris, 75013, France

  • Hopital de la Timone

    RECRUITING

    Marseille, 13005, France

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • LSU Health Sciences Center - New Orleans

    COMPLETED

    New Orleans, Louisiana, 70112, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Cancer Center

    COMPLETED

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Cancer Center - Rochester

    COMPLETED

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina - Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center*

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33612, United States

  • Montreal Neurological Institute and Hospital, McGill University

    RECRUITING

    Montreal, Quebec, H3A 2B4, Canada

  • Northern Sydney Cancer Centre/Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Ohio State University Cancer Center

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43210, United States

  • Perlmutter Cancer Center, NYU Langone Health

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, Australia

  • Piedmont Atlanta Hospital

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30309, United States

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C1, Canada

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4029, Australia

  • St. Joseph Hospital

    RECRUITING

    Orange, California, 92868, United States

  • Stanford Cancer Center

    COMPLETED

    Stanford, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Sylvester Comprehensive Cancer Center*

    RECRUITING

    Miami, Florida, 33136, United States

  • Texas Oncology - Austin

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78705, United States

  • Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie

    ACTIVE_NOT_RECRUITING

    Cologne, 50937, Germany

  • Universitaetsklinikum Heidelberg - Neurologische Klinik

    RECRUITING

    Mannheim, 68167, Germany

  • University Hospital Zurich

    RECRUITING

    Zurich, Switzerland

  • University Hospitals Cleveland Medical Center*

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of California, Los Angeles

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of California, San Francisco

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94143, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Mississippi Medical Center

    COMPLETED

    Jackson, Mississippi, 39213, United States

  • University of Pennsylvania - Perelman Center for Advanced Medicine

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas - MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75390, United States

  • University of Utah - Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Virginia Health

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington Medical Center

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98101, United States

  • Universitätsklinik Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Regensburg

    RECRUITING

    Regensburg, 93053, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Université de Sherbrooke

    ACTIVE_NOT_RECRUITING

    Sherbrooke, Quebec, J1H 5H3, Canada

  • Washington University School of Medicine - Siteman Cancer Center

    COMPLETED

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute of Emory University

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • Yale Cancer Center / Smilow Cancer Hospital*

    RECRUITING

    New Haven, Connecticut, 06511, United States

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