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

Running, not enrolling · Phase 1

Conditions studied: Astrocytoma, Oligodendroglioma

In brief

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

Key facts

Study ID

NCT05484622

Run by

Institut de Recherches Internationales Servier

People needed

60

Starts

2023-01-20

Expected to finish

2027-08-30

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have Karnofsky Performance Status (KPS) of ≥ 70%.
• Have expected survival of ≥ 3 months.
• 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)
• Have:
• Documented IDH1-R132H gene mutation; and
• 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.
• 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.
• Have recurrent or progressive disease and received prior treatment with chemotherapy, radiation, or both.
• 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).

You may not qualify if…

• 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.
• Have received 2 or more courses of radiation.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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