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RecruitingLast updated: 30 June 2026

CHONQUER: This study is recruiting people with chondrosarcoma with an IDH1 mutation to evaluate the effectiveness of a targeted therapy drug (called Ivosidenib) compared to placeboA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

Trial purpose

Medical clipboardCancer treatment

Tumor type

Sarcoma Cancers Sarcoma

Age

People18+

Trial acronym

CHONQUER

Clinical summary

Summary

To be eligible for this study, participants are required to have a diagnosis of IDH1 gene-mutated, locally advanced or metastatic conventional chondrosarcoma (Grades 1, 2 or 3) and not be eligible for curative surgery (also called resection). 

IDH1 mutant status will be determined during the pre-screening or screening phase. Participants must have radiographic progression or recurrence of their disease, and have received either none or one prior systemic treatment regimen for their advanced or metastatic disease.

Eligible participants will be randomly allocated (by chance) to one of two arms.

In the Experimental Arm, participants will receive Ivosidenib targeted therapy, which will be given as two oral tablets to be taken daily.

In the Placebo Comparator Arm, participants will receive a placebo tablets, also to be taken daily. Participants randomised 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.

Conditions

This trial is treating people with conventional chondrosarcoma with an IDH1 mutation who have received 0-1 prior systemic treatments in the advanced or metastatic setting

Eligibility

Inclusion

  • 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

  • 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).

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Servier Bio-Innovation LLC

Scientific Title

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

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