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NCT Number: NCT07221149

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 (ROSETTA Gastric-204)

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro Médico Fleischer, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
  • Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.
  • Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
  • Participants must have measurable disease as defined by RECIST v1.1.

Exclusion criteria

  • Participants must not have untreated known central nervous system (CNS) metastases.
  • Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
  • Participants must not have evidence of major coagulation disorders (eg, hemophilia).
  • Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.
  • Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
  • Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327, PM8002

FOLFOX

Drug

Specified dose on specified days

Capox

Drug

Specified dose on specified days

Nivolumab

Drug

Specified dose on specified days

Primary outcomes

  1. Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment

    Time frame: Up to 2 years after the last participant is randomized

    Phase 2

  2. Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)

    Time frame: Up to approximately 33 months

    Phase 3

  3. Overall survival (OS)

    Time frame: Up to approximately 47 months

    Phase 3

Secondary outcomes

  1. PFS by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 33 months

    Phase 2

  2. Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 33 months

    Phase 2

  3. Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 33 months

    Phase 2

  4. Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 33 months

    Phase 2

  5. Recommended dose of Pumitamig for Phase 3

    Time frame: Up to approximately 33 months

    Phase 2

  6. Objective response (OR) by RECIST v1.1 per BICR

    Time frame: Up to approximately 33 months

    Phase 3

  7. DOR by RECIST v1.1 per BICR

    Time frame: Up to approximately 33 months

    Phase 3

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • BioNTech SE

Registry information

Official study title

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Oct 27, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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