OncoMatch/Clinical Trials/NCT06127407
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Is NCT06127407 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Ivosidenib 500mg for locally advanced or metastatic conventional chondrosarcoma with an idh1 mutation, untreated or previously treated with 1 systemic treatment regimen.
Treatment: Ivosidenib 500mg — Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: IDH1 R132C
IDH1 gene-mutated disease ... R132C/L/G/H/S mutation variants tested
Required: IDH1 R132L
IDH1 gene-mutated disease ... R132C/L/G/H/S mutation variants tested
Required: IDH1 R132G
IDH1 gene-mutated disease ... R132C/L/G/H/S mutation variants tested
Required: IDH1 R132H
IDH1 gene-mutated disease ... R132C/L/G/H/S mutation variants tested
Required: IDH1 R132S
IDH1 gene-mutated disease ... R132C/L/G/H/S mutation variants tested
Disease stage
Required: Stage III, IV
Grade: 123
Prior therapy
Cannot have received: idh1 inhibitor
Lab requirements
Cardiac function
Significant active cardiac disease within 6 months prior to randomization, including NYHA Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke. LVEF <40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization. QTcF ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events.
Significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke. LVEF <40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization. QTcF ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Usc Norris Comprehensive Cancer Center · Los Angeles, California
- Sarcoma Oncology Research Center · Santa Monica, California
- University of Colorado Cancer Center · Aurora, Colorado
- Yale Cancer Center · New Haven, Connecticut
- Mayo Clinic - Jacksonville, Fl · Jacksonville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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