Full Title: Ivosidenib in Participants with Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated with 1 Systemic Treatment Regimen
Status: Active, Recruiting
Age Range: 18 years and older
Locations:
- Royal Marsden NHS Foundation Trust, London
- The Christie NHS Foundation Trust, Manchester
Registry Number: NCT06127407
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.
If you would like any more information on clinical trials in general, please contact us at The Bone Cancer Research Trust. For more information on this trial and to understand if you are eligible, please talk to your clinical team.
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