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

Sarcoma
Bone sarcomas
First-Line-Therapy (Metastatic Disease/Hematology)
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind,randomized, placebo-controlled study of orally administered ivosidenib. Participants arerequired 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 determinedduring pre-screening/screening phase. Participant must have radiographicprogression/recurrence of disease according to Response Evaluation Criteria in SolidTumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in theadvanced/metastatic setting for conventional chondrosarcoma. The primary endpoint isprogression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpointsare PFS in all randomized participants, overall survival (OS) in Grades 1 and 2participants, and OS in all randomized participants.Participants who m
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