Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen (NCT06127407)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Usc Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (114 Sites)
Showing the first 25 of 114 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
- University of Miami — Miami, Florida
- Emory Winship Cancer Institute — Atlanta, Georgia
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois
- University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center — Iowa City, Iowa
- Johns Hopkins University — Baltimore, Maryland
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic - Rochester, Mn — Rochester, Minnesota
- The Washington University — St Louis, Missouri
- Nebraska Methodist Hospital — Omaha, Nebraska
- Memorial Sloan Kettering Cancer Center — New York, New York
- Duke University — Durham, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Oregon Health & Science University Knight Cancer Institute — Portland, Oregon
- University of Pittsburgh Medical Center-Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- The Univeristy of Texas Md Anderson Cancer Center — Houston, Texas
- Flinders Medical Centre — Bedford Park,
- Chris O'Brien Lifehouse — Camperdown,
- Chris O'Brien Lifehouse — Camperdown,
📞 Contact the Study Coordinator
Phone: +33 1 55 72 60 00
Email: scientificinformation@servier.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.