NCT07284849

A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

Conditions

• CRC (Colorectal Cancer)

Interventions

Type	Name	Description
DRUG	INCA33890	INCA33890 will be administered at protocol defined dose.
DRUG	Placebo	Placebo will be administered at protocol defined dose.
DRUG	Bevacizumab	Bevacizumab will be administered at protocol defined dose.
DRUG	FOLFOX	FOLFOX will be administered at protocol defined dose.

Timeline

• Start date: 2026-03-05
• Primary completion: 2028-12-29
• Completion: 2029-09-28
• First posted: 2025-12-16
• Last updated: 2026-04-16

Locations

272 sites across 21 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Georgia, Germany, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study