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RECRUITING Phase 3

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

NCT06127407 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Ivosidenib 500mg

Study Locations (20)

California

  • Usc Norris Comprehensive Cancer Center — Los Angeles
  • Sarcoma Oncology Research Center — Santa Monica

Florida

  • Mayo Clinic - Jacksonville, Fl — Jacksonville
  • University of Miami — Miami

Ohio

  • Cleveland Clinic — Cleveland
  • The Ohio State University Comprehensive Cancer Center — Columbus

Colorado

  • University of Colorado Cancer Center — Aurora

Connecticut

  • Yale Cancer Center — New Haven

Georgia

  • Emory Winship Cancer Institute — Atlanta

Illinois

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago

Iowa

  • University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center — Iowa City

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2024-07-09
Est. Completion 2030-11-26
Phase Phase 3

Sponsor

Servier Bio-Innovation

36 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06127407

The ClinicalTrials.gov registry entry for NCT06127407 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06127407 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06127407 about?

NCT06127407 is a clinical study titled "Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen". 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 advan...

What is the current status of trial NCT06127407?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2024-07-09. Estimated completion is 2030-11-26.

What conditions does trial NCT06127407 study?

This clinical trial studies the following conditions: Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06127407?

The interventions under investigation include: Placebo (DRUG), Ivosidenib 500mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06127407?

This trial is sponsored by Servier Bio-Innovation, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06127407 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial