A Phase 2/3 interventional study of Pumitamig and Folfox in Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, sponsored by Bristol-Myers Squibb. Recruiting at 161 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Bristol-Myers Squibb · Phase 2/3, Interventional, and Treatment
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
Exclusion Criteria
Drug: Pumitamig · Drug: Folfox · Drug: Capox
Drug: Pumitamig · Drug: Folfox · Drug: Capox
Drug: Pumitamig · Drug: Folfox · Drug: Capox
Drug: Folfox · Drug: Capox · Drug: Nivolumab
Specified dose on specified days
Also known as: BMS-986545, BNT327, PM8002
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
Time frame: Up to 2 years after the last participant is randomized
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Time frame: Up to approximately 33 months
Overall survival (OS)
Phase 3
Time frame: Up to approximately 47 months
PFS by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Recommended dose of Pumitamig for Phase 3
Phase 2
Time frame: Up to approximately 33 months
Objective response (OR) by RECIST v1.1 per BICR
Phase 3
Time frame: Up to approximately 33 months
DOR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to approximately 33 months
Showing the first 100 of 161 sites across 20 countries.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
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Bristol-Myers Squibb