A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Not Applicable

Not yet recruiting

• Conditions: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
• Interventions: Drug: Pumitamig; Drug: Nivolumab; Drug: Folfox; Drug: Capox

• Registration Number: NCT07221149
• 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 Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

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: 2026-03-09
• Primary Completion: 2030-11-08
• Study Completion: 2032-09-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 690

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 B	Nivolumab	-
Arm A1	Folfox	-
Arm C	Pumitamig	-
Arm D	Capox	-
Arm D	Nivolumab	-
Arm A2	Pumitamig	-
Arm B	Folfox	-
Arm A2	Folfox	-
Arm C	Folfox	-
Arm C	Capox	-
Arm D	Folfox	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to approximately 47 months	Phase 3
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 2 years after the last participant is randomized	Phase 2
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)	Up to approximately 33 months	Phase 3

Secondary Outcome Measures

Name	Time	Method
PFS by RECIST v1.1 per investigator assessment	Up to approximately 33 months	Phase 2
Recommended dose of Pumitamig for Phase 3	Up to approximately 33 months	Phase 2
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment	Up to approximately 33 months	Phase 2
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment	Up to approximately 33 months	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 approximately 33 months	Phase 2
Objective response (OR) by RECIST v1.1 per BICR	Up to approximately 33 months	Phase 3
DOR by RECIST v1.1 per BICR	Up to approximately 33 months	Phase 3

Trial Locations

Locations (136)

Local Institution - 0284; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0240; 🇺🇸 Los Angeles, California, United States

Local Institution - 0277; 🇺🇸 Orange, California, United States

Local Institution - 0246; 🇺🇸 Tampa, Florida, United States

Local Institution - 0377; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0379; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0268; 🇺🇸 Iowa City, Iowa, United States

Local Institution - 0386; 🇺🇸 Lake Success, New York, United States

Local Institution - 0242; 🇺🇸 New York, New York, United States

Local Institution - 0222; 🇺🇸 Cleveland, Ohio, United States

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