MedTrace Logo

VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

NCT07629089 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-05

No results posted yet for this study

Summary

This study will test the hypothesis that vorasidenib in combination with lomustine will be safe and tolerable. The overall goal of this study is to identify the optimal vorasidenib dose that can be tested in a subsequent phase 2 study to determine the efficacy of vorasidenib in combination with lomustine in patients with recurrent IDH mutant gliomas.

Conditions

Interventions

DRUG

Vorasidenib

Oral targeted therapy for IDH1- or IDH2-mutant grade 2 astrocytoma or oligodendroglioma, approved for use after surgery.

DRUG

Lomustine

An alkylating nitrosourea compound used in chemotherapy. It is highly lipid-soluble thus it crosses the blood-brain barrier. Primarily used in treating brain tumors.

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Megan Mantica

    lead OTHER

Principal Investigators

  • Megan Mantica, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-06-30
Completion
2035-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07629089 on ClinicalTrials.gov