Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer

Phase 2

Not yet recruiting

• Conditions: Microsatellite-stable Colorectal Cancer; Standard of Care; Nivolumab; Bevacizumab
• Interventions: Drug: Nivolumab; Drug: Bevacizumab; Drug: BMS-986340; Drug: Trifluridine + Tipiracil

• Registration Number: NCT07011550
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.

Detailed Description

Primary Objectives

* To determine the safety of the combination of BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab.

* To determine the objective response rate (ORR) of the BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab

Secondary Objectives

• To determine the progression-free survival (PFS), overall survival (OS) and duration of response (DOR) in participants with advanced or metastatic MSS-CRC.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-09
• Last Update Posted: 2025-06-09
• Study Start: 2025-11-30
• Primary Completion: 2028-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SLI/Exp	Nivolumab	SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W
SLI/Exp	Bevacizumab	SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W
SLI/Exp	BMS-986340	SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W
SLI/Exp	Trifluridine + Tipiracil	SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States