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New drug combo takes on recurrent brain tumors

NCT ID NCT05484622

Disease control Sponsor: Institut de Recherches Internationales Servier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial is testing whether combining two drugs—vorasidenib and pembrolizumab—can help people with a specific type of brain tumor (IDH-1 mutant glioma) that has come back or is growing. About 60 participants will receive the drugs before and after surgery to remove their tumor. The main goals are to check safety and see how the drugs affect immune cells in the tumor.

What this could mean

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

Active substance
vorasidenib and pembrolizumab
What this could lead to
If it works, this could point toward a new combination treatment for a type of brain tumor that has come back.
What could go wrong
This is a very early phase 1 trial with only 60 people, so it is mainly checking safety and dosing. It may not lead to a proven treatment, and side effects from the drug combination are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Aug 2027

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.

Inclusion Criteria: 1. Have Karnofsky Performance Status (KPS) of ≥ 70%. 2. Have expected survival of ≥ 3 months. 3. Have histologically confirmed Grade 2 or Grade 3 glioma (per the 2016 or 2021 World Health Organization \[WHO\] Classification of Tumors of the central nervous system) 4. Have: 1. Documented IDH1-R132H gene mutation; and 2. For Astrocytomas: Absence of 1p19q co-deletion (i.e., exclusion of combined whole-arm deletions of 1p and 19q) and/or documented loss of nuclear ATRX expression or ATRX mutation by local testing. For Oligodendrogliomas: Presence of 1p19q co-deletion (i.e., combined whole-arm deletions of 1p and 19q) by local testing. 5. Have measurable, magnetic resonance imaging (MRI)-evaluable, unequivocal contrast enhancing disease as determined by institutional radiologist/Investigator at Screening on either 2D T1 post-contrast weighted images or 3D T1 post-contrast weighted images. Per mRANO criteria, measurable lesion is defined as at least 1 enhancing lesion measuring ≥ 1 cm x ≥ 1 cm. OR (in the absence of measurable enhancing disease) measurable, MRI-evaluable, unequivocal non enhancing disease as determined by institutional radiologist/Investigator at Screening on either 2D or 3D T2-weighted image or FLAIR. Per RANO 2.0 criteria, measurable lesion is defined as at least 1 non enhancing lesion measuring ≥ 1 cm × ≥ 1 cm. 6. Have recurrent or progressive disease and received prior treatment with chemotherapy, radiation, or both. 7. Surgical resection is indicated for treatment, but surgery is not urgently indicated (e.g., for whom surgery within the next 6-9 weeks is appropriate). (NOTE: This criterion only applies to participants enrolled in the perioperative phase of the study. Participants in the Safety Lead-In should not require surgery). Exclusion Criteria: 1. Have received prior systemic anti-cancer therapy within 1 month of the first dose of IMP, radiation within 12 months of the first dose of IMP, or an investigational agent \< 14 days prior to the first dose of IMP. In addition, the first dose of IMP should not occur before a period of ≥ 5 half-lives of the investigational agent has elapsed. 2. Have received 2 or more courses of radiation. 3. Have received any prior treatment with an isocitrate dehydrogenase (IDH) inhibitor; anti-programmed cell death 1 (PD1), anti-programmed cell death ligand 1 (PD-L1), or anti-PD-ligand 2 (L2) agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137); any other checkpoint inhibitor; bevacizumab; or any prior vaccine therapy. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) oligodendroglioma

As listed by the trial registrant

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

Astrocytoma Oligodendroglioma

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute (Site: 840139)

    Boston, Massachusetts, 02215, United States

  • Duke University (Site: 840110)

    Durham, North Carolina, 27705, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center (Site: 840102)

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital (Site: 840104)

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Florida

    Cleveland, Ohio, 44195, United States

  • Memorial Sloan Kettering Cancer Center (Site: 840117)

    New York, New York, 10017, United States

  • Northwestern University (Site: 840123)

    Chicago, Illinois, 60045, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California, Los Angeles (Site: 840113)

    Los Angeles, California, 90095, United States

  • University of California, San Francisco (Site: 840149)

    San Francisco, California, 94013, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami (Site: 840129)

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah, Huntsman Cancer Center

    Salt Lake City, Utah, 84112, United States

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