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RecruitingInterventionalPhase 2/Phase 3

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

NCT ID: NCT07221149Sponsor: Bristol-Myers SquibbLast updated: 2026-06-04

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

Arms & interventions

  • DrugPumitamig

    Specified dose on specified days

  • DrugFolfox

    Specified dose on specified days

  • DrugCapox

    Specified dose on specified days

  • DrugNivolumab

    Specified dose on specified days

Outcome measures

Primary

  • 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

Secondary

  • PFS by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 33 months

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

    Time frame: Up to approximately 33 months

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

    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

    Time frame: Up to approximately 33 months

  • Recommended dose of Pumitamig for Phase 3

    Time frame: Up to approximately 33 months

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

    Time frame: Up to approximately 33 months

  • DOR by RECIST v1.1 per BICR

    Time frame: Up to approximately 33 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (34)

Local Institution - 0284

Phoenix, Arizona, 85054

Not Yet Recruiting
Site 0284 · Contact

Local Institution - 0437

Los Angeles, California, 90033

Not Yet Recruiting
Site 0437 · Contact

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Orange, California, 92868

Recruiting
Farshid Dayyani, Site 0277 · Contact

Local Institution - 0428

San Francisco, California, 94158

Not Yet Recruiting
Site 0428 · Contact

Florida Cancer Specialists - South

Fort Myers, Florida, 33901

Recruiting
Fadi Kayali, Site 0429 · Contact

Local Institution - 0433

Jacksonville, Florida, 32224

Not Yet Recruiting
Site 0433 · Contact

Florida Cancer Specialists - North

St. Petersburg, Florida, 33701

Recruiting
Muhammad Imam, Site 0430 · Contact

Local Institution - 0246

Tampa, Florida, 33612

Not Yet Recruiting
Site 0246 · Contact

Local Institution - 0377

Atlanta, Georgia, 30308

Not Yet Recruiting
Site 0377 · Contact

Local Institution - 0379

Chicago, Illinois, 60637

Not Yet Recruiting
Site 0379 · Contact

Local Institution - 0268

Iowa City, Iowa, 52242

Not Yet Recruiting
Site 0268 · Contact

Local Institution - 0259

Rochester, Minnesota, 55905

Not Yet Recruiting
Site 0259 · Contact

Missouri Cancer Associates

Columbia, Missouri, 65201

Recruiting
Caleb Smith, Site 0426 · Contact

Local Institution - 0286

Omaha, Nebraska, 68198

Not Yet Recruiting
Site 0286 · Contact

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, 11042

Recruiting
Nicholas Hornstein, Site 0386 · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Yelena Janjigian, Site 0242 · Contact

Local Institution - 0274

Rochester, New York, 14642

Not Yet Recruiting
Site 0274 · Contact

Local Institution - 0245

Chapel Hill, North Carolina, 27599

Not Yet Recruiting
Site 0245 · Contact

Local Institution - 0443

Cleveland, Ohio, 44106

Not Yet Recruiting
Site 0443 · Contact

Local Institution - 0222

Cleveland, Ohio, 44195

Not Yet Recruiting
Site 0222 · Contact

Oncology Associates Of Oregon, Pc

Eugene, Oregon, 97401

Recruiting
Marc Uemura, Site 0432 · Contact

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97213-2982

Recruiting
Spencer Shao, Site 0419 · Contact

Local Institution - 0407

Pittsburgh, Pennsylvania, 15213

Not Yet Recruiting
Site 0407 · Contact

Local Institution - 0255

Nashville, Tennessee, 37203

Not Yet Recruiting
Site 0255 · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Meredith Pelster, Site 0417 · Contact

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas, 79124

Recruiting
Anton Melnyk, Site 0423 · Contact

Texas Oncology-Austin Central

Austin, Texas, 78731

Recruiting
Vivian Cline, Site 0416 · Contact

Texas Oncology

Beaumont, Texas, 77702

Recruiting
Pavel Levin, Site 0424 · Contact

Texas Oncology - Northeast Texas

Denison, Texas, 75020

Recruiting
Amir Faridi, Site 0415 · Contact

Texas Oncology - DFW

Grapevine, Texas, 76051

Recruiting
Ravi Patel, Site 0421 · Contact

Local Institution - 0233

Houston, Texas, 77030

Not Yet Recruiting
Site 0233 · Contact

Texas Oncology - San Antonio

San Antonio, Texas, 78240

Recruiting
John R. Ogden, Site 0427 · Contact

Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem

Salem, Virginia, 24153

Recruiting
Mark Kochenderfer, Site 0413 · Contact

Local Institution - 0271

Madison, Wisconsin, 53792

Not Yet Recruiting
Site 0271 · Contact