Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Condition(s) studied
Investigational drug(s) / intervention(s)
Ivosidenib 500mg: Provided as tablets, taken orally as two 250mg tablets once daily.
Placebo: Provided as tablets, taken orally once daily.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants — Up to approximately 31 months
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Trial sites (114)
| Facility | City | Region | Status |
|---|---|---|---|
| Usc Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Sarcoma Oncology Research Center | Santa Monica | California | Recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Mayo Clinic - Jacksonville, Fl | Jacksonville | Florida | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Emory Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | Recruiting |
| University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center | Iowa City | Iowa | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Mayo Clinic - Rochester, Mn | Rochester | Minnesota | Recruiting |
| The Washington University | St Louis | Missouri | Recruiting |
| Nebraska Methodist Hospital | Omaha | Nebraska | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | Recruiting |
| Oregon Health & Science University Knight Cancer Institute | Portland | Oregon | Recruiting |
| University of Pittsburgh Medical Center-Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| The Univeristy of Texas Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Flinders Medical Centre | Bedford Park | Australia | Recruiting |
| Chris O'Brien Lifehouse | Camperdown | Australia | Not Yet Recruiting |
| Chris O'Brien Lifehouse | Camperdown | Australia | Recruiting |
| St Vincent'S Hospital Melbourne | Fitzroy | Australia | Recruiting |
| Sir Charles Gairdner Hospital | Nedlands | Australia | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Australia | Recruiting |
| Cliniques Universitaires St. Luc | Brussels | Belgium | Recruiting |
| U.Z. Gent | Ghent | Belgium | Recruiting |
| Centre Multidisciplinaire de Oncologie Medicale | Liège | Belgium | Recruiting |
| Liga Norte Riograndense Contra O Cancer | Natal | Rio Grande do Norte | Recruiting |
| Hospital de Amor - Barretos | Barretos | Brazil | Recruiting |
| Hospital Das Clínicas Da Ufmg | Belo Horizonte | Brazil | Recruiting |
| CIONC | Curitiba | Brazil | Recruiting |
| Cepon - Centro de Pesquisas Oncologicas | Florianópolis | Brazil | Recruiting |
| Fundação Amaral Carvalho - Jaú/ Sp | Jaú | Brazil | Recruiting |
| Instituto Nacional Do Câncer - Inca | Rio de Janeiro | Brazil | Recruiting |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | Brazil | Recruiting |
| Impar Serviços Hospitalares S.A. - Hospital Nove de Julho | São Paulo | Brazil | Recruiting |
+ 74 more sites — see the full list on the official registry below.
More Servier Bio-Innovation LLC trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06127407 on ClinicalTrials.gov ↗ ← All trials in Spain