CHONQUER: Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
This is a Phase 3, multicenter study of a chemotherapy medicine called ivosidenib. This study, sponsored by Servier is open to adults ages 18 and older in the United States, Australia, Brazil, Canada, and Japan. Patients must have a diagnosis of locally advanced or metastatic conventional chondrosarcoma (Grades 1, 2, or 3), must not be eligible for curative resection, and must have a confirmed IDH1 mutation.
Patients eligible for this trial will receive an oral medication or a placebo taken as two tablets once a day. Patients receiving the study medication (ivosidenib) will take the medication continuously until their disease progresses or unacceptable side effects occur. Patients receiving the placebo pills will take the medication continuously until their disease progresses, at which point they may be eligible to cross over and receive ivosidenib.
This study will help doctors and scientists understand if the oral medication ivosedinib is an effective treatment option for patients with IDH1-mutated conventional chondrosarcoma. The medication works by inhibiting (blocking the action of) the IDH1 protein that is mutated in several kinds of cancer, including some chondrosarcoma. Ivosedinib is an FDA-approved medication that is already used for the treatment of acute myeloid leukemia and cholangiocarcinoma under the trade name Tibsovo.
There are additional eligibility and exclusion criteria, including minimum organ function requirements, mutation status requirements, and prior therapy considerations. Patients of child-bearing potential will be removed from the study if they become pregnant while enrolled. Patients interested in this study should review these criteria with their doctor. To learn more about this study, patients and/or care partners can talk to their doctor, contact the investigator at the site nearest you or your primary treatment center, or contact the study coordinator.
ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06127407
Sponsor website: https://servier.com/en/research-innovation/our-development-pipeline/