Recruiting
Phase 3

Ivosidenib

Sponsor:

Servier Bio-Innovation LLC

Code:

NCT06127407

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ivosidenib 500mg

Placebo

Study Details

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 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.

Conditions

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

Study ID

NCT06127407

Start date

Jul 9, 2024

Status verified date

Feb, 2026

Completion date

Nov 26, 2030

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. 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
2. 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ivosidenib

Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years).

placebo comparator: Placebo

Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years). Participants randomized to the placebo arm who experience BICR-confirmed disease progression and meet the crossover eligibility criteria will be given the opportunity to cross over and receive ivosidenib.

Interventions

Ivosidenib 500mg

Provided as tablets, taken orally as two 250mg tablets once daily.

Placebo

Provided as tablets, taken orally once daily.

Primary outcome measure

  • Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants [ Time Frame: Up to approximately 31 months ]

Central Contacts and Locations

Central contacts

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

+33 1 55 72 60 00scientificinformation@servier.com

Locations

Usc Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Sarcoma Oncology Research Center

Recruiting

Santa Monica, California, United States, 90403

Contacts

Victoria Chua-Alcala, MD

310-552-9999vchua@sarcomaoncology.com

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Sharon Huie

475-331-5081sharon.huie@yale.edu

Mayo Clinic - Jacksonville, Fl

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Steven Attia, Dr

attia.steven@mayo.edu

University of Miami

Recruiting

Miami, Florida, United States, 33136-1002

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

William Read

william.l.read@emory.edu

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Recruiting

Chicago, Illinois, United States, 60611-5975

University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

DFCI Sarcoma Center

617-632-5204

Mayo Clinic - Rochester, Mn

Recruiting

Rochester, Minnesota, United States, 55905

The Washington University

Recruiting

St Louis, Missouri, United States, 63110

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68118

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

646-888-4163tapw@mskcc.org

Principal Investigator:

William Tap, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Richard Riedel, MD

888-275-3852vivek.bhadri@lh.org.au

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

216-444-7923cancerawareness@ccf.org

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Luiza Stoeva

614-814-1053SarcomaCRCs@osumc.edu

Oregon Health & Science University Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

OHSU Clinical Trials Office

503-494-1080trials@ohsu.edu

University of Pittsburgh Medical Center-Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Clinical Research Coordinator

800-811-8480cip@vumc.org

The Univeristy of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2N-5G2

Contacts

Matthew Young

matthew.young@albertahealthservices.ca

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

4165964200

Principal Investigator:

ABDULAZEEZ SALAWU, MD

Muhc Glen Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

5149341934ramy.saleh.med@ssss.gouv.qc.ca

Principal Investigator:

Ramy Saleh, MD

More Information

Sponsor

Servier Bio-Innovation LLC

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Conventional chondrosarcoma
  • IDH1
  • ivosidenib
  • locally advanced
  • metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Servier Bio-Innovation LLC on 2026-02-06.