NCT06792695

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

Detailed description

This is a Phase II, platform, open-label, multi-drug, multicenter, global study. This is a modular study, that includes a master protocol and substudies. Partcipants will be randomised to one of the following intervention groups: * Volrustomig + FOLFIRI + bevacizumab group (Arm A) * FOLFIRI + bevacizumab group (Arm B) The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Volrustomig	Volrustomig will be administered as intravenous (IV) infusion.
DRUG	FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)	FOLFIRI will be administered as IV infusion.
DRUG	Bevacizumab	Bevacizumab will be administered as IV infusion.

Timeline

• Start date: 2025-03-12
• Primary completion: 2027-05-31
• Completion: 2028-06-07
• First posted: 2025-01-27
• Last updated: 2026-01-20

Locations

76 sites across 12 countries: United States, Australia, Canada, China, France, Germany, Italy, Netherlands, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study