Skip to content

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 (CHONQUER study)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508507-20-00
Acronym
CL3-95031-007
Enrollment
91
Registered
2024-06-10
Start date
2025-04-03
Completion date
Unknown
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 systemic treatment regimen

Brief summary

Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants

Detailed description

PFS based on BICR assessment in all randomized participants, Overall survival (OS) in Grade 1 and Grade 2 participants, OS in all randomized participants, PFS based on Investigator assessment in Grade 1 and Grade 2 participants and in all randomised participants, Objective response (OR) (complete response(CR) or partial response (PR)) of anti-tumor activity (using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of response (DOR) in Grade 1 and Grade 2 participants and in all randomised participants, Time to response (TTR) in Grade 1 and Grade 2 participants and in all randomised participants, Disease control (DC) CR, PR, or stable disease (SD)) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of disease control (DoDC) in Grade 1 and Grade 2 participants and in all randomised participants, Number of Adverse Events (AEs), Number of Serious Adverse Events (SAEs), Number of Adverse Events of Special Interest (AESIs), Number of Adverse Events (AEs) leading to discontinuation, treatment interruption, and dose reduction, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) score, European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score, Patient-Reported Outcomes Measurement Information System (PROMIS) score, Ivosidenib and 2-hydroxyglutarate (2-HG) concentration in plasma

Interventions

Sponsors

Institut De Recherches Internationales Servier IRIS
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants

Secondary

MeasureTime frame
PFS based on BICR assessment in all randomized participants, Overall survival (OS) in Grade 1 and Grade 2 participants, OS in all randomized participants, PFS based on Investigator assessment in Grade 1 and Grade 2 participants and in all randomised participants, Objective response (OR) (complete response(CR) or partial response (PR)) of anti-tumor activity (using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of response (DOR) in Grade 1 and Grade 2 participants and in all randomised participants, Time to response (TTR) in Grade 1 and Grade 2 participants and in all randomised participants, Disease control (DC) CR, PR, or stable disease (SD)) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of disease control (DoDC) in Grade 1 and Grade 2 participants and in all randomised participants, Number of Adverse Events (AEs), Number of Serious Adverse Events (SAEs), Nu

Countries

Belgium, Denmark, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026