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.
Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1. Participants who have received prior radiation therapy are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
Have received 0 or 1 prior systemic treatment regimen in the advanced/metastatic setting for chondrosarcoma.
Radiographic progression of disease (local and/or distant) documented by 2 imaging assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.
Are unable to swallow oral medication.
Pregnant or lactating women.
Are participating in another interventional study at the same time; participation in noninterventional registries or epidemiological studies is allowed.
Have received prior therapy with an IDH1 inhibitor
Parallel
Ivosidenib 500mg
DrugProvided as tablets, taken orally as two 250mg tablets once daily.
Placebo
DrugProvided as tablets, taken orally once daily.
Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
PFS based on BICR assessment in all randomized participants
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Overall survival (OS) in Grade 1 and Grade 2 participants
From randomization until death
OS in all randomized participants
From randomization until death
PFS based on Investigator assessment in Grade 1 and Grade 2 participants
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
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Servier Bio-Innovation LLC
Lead sponsor
Institut de Recherches Internationales Servier
Collaborator
