Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Phase 2 Unknown 48 enrolled Sun Yat-sen University

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305(bevacizumab) in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

Timeline

Start: 2021-03-11
Primary completion: 2022-07-26
Completion: 2023-12

Outcome

Met primary endpoint

paper The primary endpoint of progression-free survival (PFS) rate at 18 weeks (18wPFS rate) was met with a rate of 43.8% (21 of 48) for the entire study population. PMID 38438735 ↗

Publications

Wang F, Jin Y, Wang M, Luo HY, Fang WJ, Wang YN, Chen YX, Huang RJ, Guan WL, Li JB, Li YH, Wang FH, Hu XH, Zhang YQ, Qiu MZ, Liu LL, Wang ZX, Ren C, Wang DS, Zhang DS, Wang ZQ, Liao WT, Tian L, Zhao Q, Xu RH. Combined anti-PD-1, HDAC inhibitor and anti-VEGF for MSS/pMMR colorectal cancer: a randomized phase 2 trial. Nat Med. 2024 Apr;30(4):1035-1043. doi: 10.1038/s41591-024-02813-1. Epub 2024 Mar 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous
Subject	Tucidinostat	Small molecule	30 mg	Oral