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

Active:	Yes
Cancer Type:	Sarcoma	NCT ID:	NCT06127407
Trial Phases:	Phase III	Protocol IDs:	CL3-95031-007 (primary) NCI-2024-03271
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Servier Bio-Innovation LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT06127407

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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