Recruiting

Phase 2

Phase 3

Pumitamig & NivolumabA 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)

Sponsor:

Bristol-Myers Squibb

Code:

NCT07221149

Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Folfox

Capox

Nivolumab

Study Details

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

Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Study ID

NCT07221149

Start date

Mar 13, 2026

Status verified date

Aug, 2026

Completion date

Sep 11, 2032

Anticipated

Primary completion date

Nov 8, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

690 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A1

experimental: Arm A2

experimental: Arm C

experimental: Arm D

Interventions

Pumitamig

Specified dose on specified days

Folfox

Specified dose on specified days

Capox

Specified dose on specified days

Nivolumab

Specified dose on specified days

Primary outcome measure

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 ]
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) [ Time Frame: Up to approximately 33 months ]
Overall survival (OS) [ Time Frame: Up to approximately 47 months ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

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

Recruiting

Orange, California, United States, 92868

Contacts

Farshid Dayyani, Site 0277

714-456-5153

Florida Cancer Specialists - South

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Fadi Kayali, Site 0429

239-274-9930

Florida Cancer Specialists - North

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Muhammad Imam, Site 0430

000-000-0000

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Allan Lima Pereira, Site 0246

813-745-4436

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Northwell Health/ RJ Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Nicholas Hornstein, Site 0386

323-533-7275

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Yelena Janjigian, Site 0242

646-888-4186

Oncology Associates Of Oregon, Pc

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Marc Uemura, Site 0432

541-214-8284

Northwest Cancer Specialists, P.C.

Recruiting

Portland, Oregon, United States, 97213-2982

Contacts

Spencer Shao, Site 0419

503-528-5005

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Anwaar Saeed, Site 0407

816-898-9413

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Meredith Pelster, Site 0417

615-986-4366

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Amarillo Cancer Center

Recruiting

Amarillo, Texas, United States, 79124

Contacts

Anton Melnyk, Site 0423

325-692-0188

Texas Oncology-Austin Central

Recruiting

Austin, Texas, United States, 78731

Contacts

Vivian Cline, Site 0416

512-427-9400

Texas Oncology

Recruiting

Beaumont, Texas, United States, 77702

Texas Oncology - Northeast Texas

Recruiting

Denison, Texas, United States, 75020

Contacts

Amir Faridi, Site 0415

000-000-0000

Texas Oncology - DFW

Recruiting

Grapevine, Texas, United States, 76051

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jaffer Ajani, Site 0233

713-792-2828

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

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

Recruiting

Salem, Virginia, United States, 24153

Contacts

Mark Kochenderfer, Site 0413

540-982-0237

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Nataliya Uboha, Site 0271

608-265-9966

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Elena Elimova, Site 0121

4169464501ext.2520

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

Gastric Cancer
Gastroesophageal Junction Cancer
Esophageal Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-12.