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Recruiting Phase 3 Interventional

Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

ClinicalTrials.gov ID: NCT06127407

Public ClinicalTrials.gov record NCT06127407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 4, 2026, 5:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06127407
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Servier Bio-Innovation LLC
Industry
Enrollment
136 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 8, 2024
Primary completion
Jan 31, 2028
Completion
Nov 25, 2030
Last update posted
Feb 5, 2026

2024 – 2030

United States locations

U.S. sites
22
U.S. states
19
U.S. cities
22
Facility City State ZIP Site status
Usc Norris Comprehensive Cancer Center Los Angeles California 90033 Recruiting
Sarcoma Oncology Research Center Santa Monica California 90403 Recruiting
University of Colorado Cancer Center Aurora Colorado 80045 Recruiting
Yale Cancer Center New Haven Connecticut 06511 Recruiting
Mayo Clinic - Jacksonville, Fl Jacksonville Florida 32224 Recruiting
University of Miami Miami Florida 33136-1002 Recruiting
Emory Winship Cancer Institute Atlanta Georgia 30308 Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois 60611-5975 Recruiting
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center Iowa City Iowa 52242 Recruiting
Johns Hopkins University Baltimore Maryland 21287 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Mayo Clinic - Rochester, Mn Rochester Minnesota 55905 Recruiting
The Washington University St Louis Missouri 63110 Recruiting
Nebraska Methodist Hospital Omaha Nebraska 68118 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
Duke University Durham North Carolina 27710 Recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
The Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 Recruiting
Oregon Health & Science University Knight Cancer Institute Portland Oregon 97239 Recruiting
University of Pittsburgh Medical Center-Hillman Cancer Center Pittsburgh Pennsylvania 15232 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37232 Recruiting
The Univeristy of Texas Md Anderson Cancer Center Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 91 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06127407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 5, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06127407 live on ClinicalTrials.gov.

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