What question did this study set out to answer?

To evaluate the effectiveness of nivolumab in patients with carcinosarcoma and identify predictors of response.

March 12, 2026Open Access

152P Precision immunotherapy in carcinosarcoma: Immune-active molecular subtype identifies responders in a multicenter phase II nivolumab trial

KYK-H. YunYonsei University MKM. KimSeoul National University Hospital JLJ. LeeSamsung Medical Center

Key Points

To evaluate the effectiveness of nivolumab in patients with carcinosarcoma and identify predictors of response.
Conducted a multicenter phase II trial
Included patients with histopathologically confirmed carcinosarcoma
Assessed mutation status and clinical factors through pre-screening
Randomized patients to receive either nivolumab or placebo
Of 234 patients tested for mIDH1, 39% were positive.
7% of tests were invalid due to technical issues.
Clinical factors like age and tumor site will help analyze mIDH1 status.

Abstract

mutation frequency differed depending on several factors, including sex, histological grade, and tumor site (Meijer et al).CHONQUER (NCT06127407) is an ongoing, phase 3, double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of ivosidenib in pts with locally advanced or metastatic mIDH1 cCS.The associations with clinical factors will be analyzed and reported. Methods:The CHONQUER study key eligibility criteria include a histopathological diagnosis of cCS (all grades), locally-advanced or metastatic disease not eligible for curative resection; received 0 or 1 prior systemic treatment regimen; RECIST v1.1 progression/recurrence of disease; and mIDH1 confirmed by central testing with the Ion Torrent Oncomine Dx Express Test.Patients are tested during pre-screening phase during which age, sex, primary tumor location and tumor grade are collected.Eligible pts will be randomized to receive ivosidenib 500 mg once daily or placebo.The primary endpoint is progression-free survival.Results: As of 28 November 2025, 253 pts had undergone mIDH1 central testing.Of the 234 pts with a valid central testing, 91 (39%) pts were positive for mIDH1 and 143 (61%) were IDH1 wildtype.18/253 (7%) pts had an invalid test.Age, sex, primary tumor location and tumor grade clinical factors will be analyzed and reported by mIDH1 status. Conclusions:The pre-screening for mIDH1 expression of patients in the CHONQUER study might allow us to identify subgroups of conventional chondrosarcoma patients based on demographic and tumor specific clinical factors.Clinical trial identification: NCT06127407.

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