Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT05484622
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    Administered orally as tablets.
  • Pembrolizumab — DRUG
    Administered as IV infusion.

Study Details

Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.

Key Dates

Start date
Jan 20, 2023
Status verified
Mar 2026
Primary completion
Feb 12, 2026
Completion
Aug 30, 2027

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-In Phase: Vorasidenib + Pembrolizumab
    Participants will receive vorasidenib orally, once daily (QD) in combination with pembrolizumab 200 mg intravenous (IV) infusion, once every 3 weeks (Q3W) in each 21-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
  • Experimental: Randomized Perioperative Phase: Vorasidenib + Pembrolizumab
    Participants will receive vorasidenib recommended combination dose (RCD) determined in the Safety Lead-in phase, orally, QD from Day 1 to 28 in combination with pembrolizumab 200 mg IV infusion, Q3W on Days 1 and 22 of a 28-day cycle prior to surgery.
  • Experimental: Randomized Perioperative Phase: Vorasidenib Only
    Participants will receive vorasidenib orally, QD from Day 1 to 28 of a 28-day cycle prior to surgery.
  • No Intervention: Randomized Perioperative Phase: Untreated Control Group
    Participants will not receive any treatment prior to surgery.

Primary Outcome Measure

Safety Lead-in Phase: Percentage of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: First 21 days of dosing (Cycle 1) in safety lead-in phase ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
University of California, Los Angeles (Site: 840113)Los AngelesCalifornia90095-
University of California, San Francisco (Site: 840149)San FranciscoCalifornia94013-
University of ColoradoAuroraColorado80045-
University of Miami (Site: 840129)MiamiFlorida33136-
Northwestern University (Site: 840123)ChicagoIllinois60045-
Johns Hopkins UniversityBaltimoreMaryland21287-
Dana-Farber Cancer Institute (Site: 840139)BostonMassachusetts02215-
Massachusetts General Hospital (Site: 840104)BostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Memorial Sloan Kettering Cancer Center (Site: 840117)New YorkNew York10017-
Duke University (Site: 840110)DurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44195-
Mayo Clinic FloridaClevelandOhio44195-
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
MD Anderson Cancer Center (Site: 840102)HoustonTexas77030-
University of Utah, Huntsman Cancer CenterSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California, Los Angeles (Site: 840113)· Los Angeles, CAUniversity of California, San Francisco (Site: 840149)· San Francisco, CAUniversity of Colorado· Aurora, COUniversity of Miami (Site: 840129)· Miami, FLNorthwestern University (Site: 840123)· Chicago, IL

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