Cadonilimab for PD-1/PD-L1 Blockade-refractory Microsatellite Instability-high or Mismatch Repair-deficient Advanced Colorectal Cancer: A Phase 1/2 Multicenter Trial

What this Trial Is About

Researchers are studying Cadonilimab, a bispecific anti-PD-1/CTLA-4 antibody, for patients with advanced colorectal cancer that is mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) and resistant to prior PD-1 or PD-L1 blocking treatments. This phase 1 and 2 trial aims to evaluate the objective response rate of Cadonilimab in this difficult-to-treat group. The study builds on previous findings showing resistance to PD-1 inhibitors alone and explores if combining PD-1 and CTLA-4 blockade can improve outcomes. Participants receive Cadonilimab at a dose of 6 mg/kg every two weeks, continuing until disease progression, unacceptable side effects, or a maximum treatment duration of two years. This is a single-group, multicenter trial where all subjects are treated with Cadonilimab. The study is led by Sun Yat-sen University and involves monitoring safety and treatment effects over time. During the study, participants will have regular assessments including laboratory tests for bone marrow, liver, and kidney function, and tumor evaluations based on established criteria. Researchers will measure progression-free survival at 12 months as the primary outcome, and also track overall survival, objective response rate, and treatment-related toxicities over the following years. The study will last up to five years for survival follow-up, ensuring careful monitoring of participants' health and treatment response.

Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer