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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

In brief

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.

Key facts

Study ID

NCT06127407

Run by

Servier Bio-Innovation LLC

People needed

136

Starts

2024-07-09

Expected to finish

2030-11-26

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as:
• 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.
• OR
• Any recurrence of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization.
• Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue 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 surgery, radiotherapy, or other therapy intended for the treatment of cancer.

You may not qualify if…

• 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
• Have received systemic anticancer therapy <2 weeks prior to randomization (for investigational or immune-based anticancer therapy <4 weeks).
• Have received radiotherapy <2 weeks prior to randomization.
• Have known symptomatic brain metastases requiring steroids >10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment <=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization.
• Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c) pT1-2 prostatic cancer Gleason score <6 or d) participant is free of other primary solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the opinion of the Investigator, the disease will not affect participant's outcome in the setting of current chondrosarcoma diagnosis.
• Have had major surgery within 4 weeks prior to randomization.
• Have significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke.
• Have LVEF <40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization.
• Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Participants with a bundle branch block combined with a prolonged QTcF interval may be permitted based on local cardiology assessment.
• Have known medical history of progressive multifocal leukoencephalopathy (PML).

Where it is running

• Sarcoma Oncology Research Center — Santa Monica, California, United States (enrolling)
• Usc Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Mayo Clinic - Jacksonville, Fl — Jacksonville, Florida, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Emory Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• The Washington University — St Louis, Missouri, United States (enrolling)
• Nebraska Methodist Hospital — Omaha, Nebraska, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Oregon Health & Science University Knight Cancer Institute — Portland, Oregon, United States (enrolling)
• University of Pittsburgh Medical Center-Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• The Univeristy of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Flinders Medical Centre — Bedford Park, Australia (enrolling)
• Mayo Clinic - Rochester, Mn — Rochester, Minnesota, United States (enrolling)
• Chris O'Brien Lifehouse — Camperdown, Australia (enrolling)
• St Vincent'S Hospital Melbourne — Fitzroy, Australia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.