ActiveCancerNIHR-supported projectDigestion, Kidneys & Other Organs
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)
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Mar 2031
In plain English
AI plain-English summary
A drug called ivosidenib is being tested against a placebo in people with a rare bone cancer that carries a specific genetic mutation. This trial targets conventional chondrosarcoma, a cancer of the cartilage that does not respond well to standard chemotherapy. About half of these tumours have a mutation in the IDH1 gene, which alters cell metabolism and drives tumour growth. Ivosidenib is designed to block the mutant IDH1 protein, potentially slowing or stopping the cancer. Currently, no approved targeted therapies exist for this disease after initial treatment fails. If the drug proves effective, it would become the first targeted treatment for this subset of chondrosarcoma patients. That could change clinical practice for a cancer that has seen few therapeutic advances in decades. For patients with advanced or metastatic disease, a successful outcome would mean a new option where none existed before, offering the possibility of longer disease control without the toxicity of conventional chemotherapy.
View original technical description
This is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib. This study will include participants ?18 years of age with locally advanced or metastatic conventional chondrosarcoma with an isocitrate dehydrogenase-1 (IDH1) mutation, untreated or previously treated with 1 systemic treatment regimen. Participants will be randomized 1:1 to ivosidenib or a matched placebo control. Participants must have a histopathological diagnosis (fresh or banked tumor biopsy sample, collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma. Participants must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) defined as 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 any recurrence of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization. All screening and on-study disease response assessments (Investigator and Blinded Independent Central Reviewer [BICR]) will be made according to the RECIST version 1.1. Baseline confirmation of measurable disease will be assessed by central reviewer (ie, BICR). The analysis of the primary endpoint will be based on the assessment conducted through a real-time BICR, which will enable the option for unblinding of any randomized participant and crossover for participants randomized to the placebo arm. AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
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