drugset / Trial / NCT06948448

A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

NCT06948448

Phase 2 Recruiting 144 enrolled Ono Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.

Timeline

Start
2025-11-18
Primary completion
2028-02-15
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986310 Small molecule
Background Bevacizumab Monoclonal antibody
Background Leucovorin Small molecule
Background Nivolumab Monoclonal antibody
Background Oxaliplatin Small molecule
Background fluorouracil Small molecule

Indications