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Ivosidenib for advanced or metastatic chondrosarcoma with IDH1 mutation

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

PHASE3 · Servier · NCT06127407

This study is testing if a new pill called ivosidenib can help people with advanced chondrosarcoma that has an IDH1 mutation live longer and feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment136 (estimated)
Ages18 Years and up
SexAll
SponsorServier (industry)
Drugs / interventionsradiation, prednisone
Locations114 sites (Los Angeles, California and 113 other locations)
Trial IDNCT06127407 on ClinicalTrials.gov

What this trial studies

This Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study evaluates the efficacy of orally administered ivosidenib in participants with locally advanced or metastatic conventional chondrosarcoma that has an IDH1 mutation. Eligible participants must have a histopathological diagnosis and have received 0 to 1 prior systemic treatment regimen. The primary endpoint is progression-free survival in Grades 1 and 2 participants, with secondary endpoints including overall survival. The study aims to determine the effectiveness of ivosidenib in improving patient outcomes compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are individuals with locally advanced or metastatic conventional chondrosarcoma who have an IDH1 mutation and have received no more than one prior systemic treatment.

Not a fit: Patients with curative resection eligibility or those without an IDH1 mutation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve progression-free survival for patients with advanced chondrosarcoma.

How similar studies have performed: While there have been studies on targeted therapies for chondrosarcoma, this specific approach using ivosidenib in IDH1-mutated cases is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Los Angeles, California and 113 other locations

+64 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen, Conventional chondrosarcoma, IDH1, ivosidenib, locally advanced, metastatic

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.