A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Not Applicable

Not yet recruiting

• Conditions: Untreated, Unresectable, or Metastatic Colorectal Cancer
• Interventions: Drug: Pumitamig; Drug: FOLFOX; Drug: FOLFIRI; Drug: Bevacizumab; Drug: CAPOX

• Registration Number: NCT07221357
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-23
• Last Update Submitted: 2025-10-23
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-27
• Study Start: 2026-03-04
• Primary Completion: 2030-02-02
• Study Completion: 2034-03-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 990

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A1	Pumitamig	-
Arm A1	FOLFOX	-
Arm A1	FOLFIRI	-
Arm A2	Pumitamig	-
Arm A2	FOLFOX	-
Arm A2	FOLFIRI	-
Arm B	FOLFOX	-
Arm B	FOLFIRI	-
Arm B	Bevacizumab	-
Arm C	Pumitamig	-
Arm C	FOLFOX	-
Arm C	FOLFIRI	-
Arm C	CAPOX	-
Arm D	FOLFOX	-
Arm D	FOLFIRI	-
Arm D	Bevacizumab	-
Arm D	CAPOX	-

Primary Outcome Measures

Name	Time	Method
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment	Up to 5 years	Phase 2
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)	Up to 5 years	Phase 3

Secondary Outcome Measures

Name	Time	Method
PFS by RECIST v1.1 per investigator assessment	Up to 5 years	Phase 2
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment	Up to 5 years	Phase 2
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment	Up to 5 years	Phase 2
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment	Up to 5 years	Phase 2
Recommended dose of Pumitamig for Phase 3	Up to 5 years	Phase 2
Overall Survival (OS)	Up to 5 years	Phase 3
OR by RECIST v1.1 per BICR	Up to 5 years	Phase 3
DOR by RECIST v1.1 per BICR	Up to 5 years	Phase 3

Trial Locations

Locations (183)

Local Institution - 0263; 🇺🇸 Los Angeles, California, United States

Local Institution - 0345; 🇺🇸 Orange, California, United States

Local Institution - 0317; 🇺🇸 Sacramento, California, United States

Local Institution - 0293; 🇺🇸 Stanford, California, United States

Local Institution - 0574; 🇺🇸 Cape Coral, Florida, United States

Local Institution - 0575; 🇺🇸 St. Petersburg, Florida, United States

Local Institution - 0269; 🇺🇸 Tampa, Florida, United States

Local Institution - 0276; 🇺🇸 Duluth, Georgia, United States

Local Institution - 0369; 🇺🇸 Marietta, Georgia, United States

Local Institution - 0433; 🇺🇸 Chicago, Illinois, United States

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