Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma
NCT ID: NCT05484622
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2023-01-20
2027-08-30
Brief Summary
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Detailed Description
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Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Vorasidenib
Administered orally as tablets.
Pembrolizumab
Administered as IV infusion.
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.
Vorasidenib
Administered orally as tablets.
Pembrolizumab
Administered as IV infusion.
Randomized Perioperative Phase: Vorasidenib Only
Participants will receive vorasidenib orally, QD from Day 1 to 28 of a 28-day cycle prior to surgery.
Vorasidenib
Administered orally as tablets.
Randomized Perioperative Phase: Untreated Control Group
Participants will not receive any treatment prior to surgery.
No interventions assigned to this group
Interventions
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Vorasidenib
Administered orally as tablets.
Pembrolizumab
Administered as IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles (Site: 840113)
Los Angeles, California, United States
University of California, San Francisco (Site: 840149)
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
University of Miami (Site: 840129)
Miami, Florida, United States
Northwestern University (Site: 840123)
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital (Site: 840104)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute (Site: 840139)
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center (Site: 840117)
New York, New York, United States
Duke University (Site: 840110)
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Mayo Clinic Florida
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center (Site: 840102)
Houston, Texas, United States
University of Utah, Huntsman Cancer Center
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Institut de Recherches Internationales Servier Clinical Studies Department
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: backup
References
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Wen P, Peters K, de la Fuente M, Mellinghoff I, Arrillaga-Romany I, Kumthekar P, Clarke J, Puduvalli V, de Groot J, Zhang J, Chisamore M, Abshire M, Mahboub P, Hassan I, Knipstein J, Cloughesy T. Phase 1 Safety Lead-in and Randomized Open-label Perioperative Study of Vorasidenib Combined with Pembrolizumab in Recurrent or Progressive Enhancing IDH1-mutant Astrocytomas: Safety Lead-in Results. Neuro Oncol. 2023 Nov 10;25(Supplement_5):V65. doi: https://doi.org/10.1093/neuonc/noad179.0254
Other Identifiers
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MK-3475-B39
Identifier Type: OTHER
Identifier Source: secondary_id
CL1-95032-005
Identifier Type: -
Identifier Source: org_study_id
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