Brief 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 diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advancedat a late stage, far along or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resectionsurgical removal of tissue or part/all of an organ. 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.
Intervention / Treatment
- Drug: Ivosidenib 500mg
- Drug: Placebo
Inclusion Criteria:
- Have a histopathological diagnosis (fresh or banked tumor biopsyremoval of a section of tissue to analyse for cancer cells 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 therapya treatment that uses controlled doses of radiation to damage or kill cancer cells 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.
- Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as:
- Radiographic progression of disease (local and/or distant) documented by 2 imagingtests that create detailed images of areas inside the body assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.
OR
- Any recurrenceto occur or happen again of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization.
- Radiographic progression of disease (local and/or distant) documented by 2 imagingtests that create detailed images of areas inside the body assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.
- Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissuea group of cells that work together to perform a function available that was sourced from either a primary or metastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutation variants tested)
- Have recovered from any clinically relevant sequelae and toxic effects of any prior surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence, radiotherapy, or other therapy intended for the treatment of cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.