Condition: Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen · Sponsor: Servier Bio-Innovation LLC
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department · +33 1 55 72 60 00 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| Usc Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| Sarcoma Oncology Research Center | Santa Monica, California, United States | Recruiting |
| University of Colorado Cancer Center | Aurora, Colorado, United States | Recruiting |
| Yale Cancer Center | New Haven, Connecticut, United States | Recruiting |
| Mayo Clinic - Jacksonville, Fl | Jacksonville, Florida, United States | Recruiting |
| University of Miami | Miami, Florida, United States | Recruiting |
| Emory Winship Cancer Institute | Atlanta, Georgia, United States | Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago, Illinois, United States | Recruiting |
| University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center | Iowa City, Iowa, United States | Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Mayo Clinic - Rochester, Mn | Rochester, Minnesota, United States | Recruiting |
+ 102 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06127407