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) (ROSETTA GI 204)

September 4, 2026 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

690

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

        • Not yet recruiting
        • Local Institution - 0300
        • Contact:
          • Site 0300
  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
        • Contact:
          • Julieta Grasselli, Site 0054
          • Phone Number: 541158826679
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming
        • Contact:
          • Federico Esteso, Site 0061
          • Phone Number: 01132218900
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1414
        • Recruiting
        • Centro Medico Fleischer
        • Contact:
          • Guillermo Mendez, Site 0069
          • Phone Number: +5491162691673
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Maria Alicia Verzura, Site 0066
          • Phone Number: 54111555960279
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Aflah Roohullah, Site 0176
          • Phone Number: 0472877240
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital
        • Contact:
          • Michael Allen, Site 0080
          • Phone Number: +61752021111
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Recruiting
        • Lyell McEwin Hospital
        • Contact:
          • Anas Alawawdeh, Site 0077
          • Phone Number: 0881829000
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Contact:
          • David Lau, Site 0085
          • Phone Number: (03)95946666
      • Melbourne, Victoria, Australia, 3084
        • Recruiting
        • Warringal Medical Centre
        • Contact:
          • Niall Tebbutt, Site 0400
          • Phone Number: 0410582006
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • St. John of God Murdoch Hospital
        • Contact:
          • Kynan Feeney, Site 0083
          • Phone Number: +61894389599
  • Brazil
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • Faculdade de Medicina de Sao Jose do Rio Preto
        • Contact:
          • Kathia Abdalla, Site 0221
          • Phone Number: +551733216638
    • Ceará
      • Fortaleza, Ceará, Brazil, 60115-281
        • Recruiting
        • Núcleo de Oncologia e Hematologia do Ceará
        • Contact:
          • José Rocha, Site 0208
          • Phone Number: 85999872264
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30140-085
        • Recruiting
        • Centro de Investigação Clínica Ciências Médicas
        • Contact:
          • Gabriela Freitas Chaves, Site 0204
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra O Cancer
        • Contact:
          • Sulene Oliveira, Site 0226
          • Phone Number: 5584991191032
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
          • Sergio Azevedo, Site 0210
          • Phone Number: 351222055700
      • Santa Maria, Rio Grande do Sul, Brazil, 97015-373
        • Recruiting
        • Clinica Viver
        • Contact:
          • Luis Carlos Moreira Antunes, Site 0425
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Not yet recruiting
        • Local Institution - 0088
        • Contact:
          • Site 0088
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Elena Elimova, Site 0121
          • Phone Number: 4169464501ext.2520
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Not yet recruiting
        • Local Institution - 0175
        • Contact:
          • Site 0175
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Santiago, Santiago Metropolitan, Chile, 7710007
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Not yet recruiting
        • Local Institution - 0055
        • Contact:
          • Site 0055
  • China
      • Shanghai, China, 200032
        • Not yet recruiting
        • Local Institution - 0269
        • Contact:
          • Site 0269
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Lin Shen, Site 0418
          • Phone Number: 13911219511
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Yigui Chen, Site 0276
          • Phone Number: 8613509339525
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Yanhong Deng, Site 0280
          • Phone Number: 8613925106525
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Local Institution - 0232
        • Contact:
          • Site 0232
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
          • Yongqiang Li, Site 0231
          • Phone Number: 13457161928
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Local Institution - 0237
        • Contact:
          • Site 0237
    • Henan
      • Weihui, Henan, China, 453100
        • Not yet recruiting
        • Local Institution - 0282
        • Contact:
          • Site 0282
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Local Institution - 0249
        • Contact:
          • Site 0249
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Local Institution - 0279
        • Contact:
          • Site 0279
    • Hunan
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Local Institution - 0292
        • Contact:
          • Site 0292
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Local Institution - 0256
        • Contact:
          • Site 0256
      • Yangzhou, Jiangsu, China, 225001
        • Not yet recruiting
        • Local Institution - 0440
        • Contact:
          • Site 0440
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • Local Institution - 0409
        • Contact:
          • Site 0409
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Not yet recruiting
        • Local Institution - 0244
        • Contact:
          • Site 0244
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Local Institution - 0273
        • Contact:
          • Site 0273
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Yong Gao, Site 0258
          • Phone Number: 8613310167477
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • Local Institution - 0243
        • Contact:
          • Site 0243
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Local Institution - 0260
        • Contact:
          • Site 0260
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Not yet recruiting
        • Local Institution - 0248
        • Contact:
          • Site 0248
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • Local Institution - 0408
        • Contact:
          • Site 0408
      • Hangzhou, Zhejiang, China, 310052
        • Not yet recruiting
        • Local Institution - 0252
        • Contact:
          • Site 0252
  • Colombia
    • Departamento de Nariño
      • Pasto, Departamento de Nariño, Colombia, 520001
        • Not yet recruiting
        • Local Institution - 0399
        • Contact:
          • Site 0399
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Not yet recruiting
        • Local Institution - 0398
        • Contact:
          • Site 0398
  • France
      • Marseille, France, 13385
        • Not yet recruiting
        • Local Institution - 0060
        • Contact:
          • Site 0060
      • Paris, France, 75015
        • Recruiting
        • Hôpital Europeén Georges Pompidou
        • Contact:
          • Aziz Zaanan, Site 0049
          • Phone Number: 33156095064
    • Auvergne-Rhône-Alpes
      • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
        • Recruiting
        • Centre Léon Bérard
        • Contact:
          • Clelia Coutzac, Site 0058
          • Phone Number: +33478785992
    • Finistère
      • Brest, Finistère, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Jean-Philippe Metges, Site 0064
          • Phone Number: 33298223428
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Contact:
          • Anthony Turpin, Site 0051
          • Phone Number: +33320445461
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Contact:
          • Yann Touchefeu, Site 0062
          • Phone Number: 33240083163
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Contact:
          • David Tougeron, Site 0046
          • Phone Number: 33549444951
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
        • Contact:
          • Annika Kurreck, Site 0089
          • Phone Number: +4930450657306
      • Frankfurt, Germany, 60488
        • Recruiting
        • Krankenhaus Nordwest GmbH
        • Contact:
          • Thorsten Goetze, Site 0134
          • Phone Number: 496976014187
      • Hamburg, Germany, 20249
        • Recruiting
        • Facharztzentrum Eppendorf
        • Contact:
          • Alexander Stein, Site 0090
          • Phone Number: 494036035220
      • Heidelberg, Germany, 69120
        • Recruiting
        • Nationales Centrum für Tumorerkrankungen (NCT)
        • Contact:
          • Georg Haag, Site 0100
          • Phone Number: 4962215637630
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
      • Mainz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
        • Contact:
          • Markus Moehler, Site 0105
          • Phone Number: 496131176076
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsmedizin Mannheim
        • Contact:
          • Ralf-Dieter Hofheinz, Site 0101
          • Phone Number: +496213832488
      • Ulm, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Contact:
          • Thomas Seufferlein, Site 0117
          • Phone Number: 4973150044500
  • India
      • Delhi, India, 110029
        • Not yet recruiting
        • Local Institution - 0403
        • Contact:
          • Site 0403
      • Puducherry, India, 605006
        • Not yet recruiting
        • Local Institution - 0302
        • Contact:
          • Site 0302
      • Pune, India, 411001
        • Not yet recruiting
        • Local Institution - 0310
        • Contact:
          • Site 0310
    • Dādra and Nagar Haveli and Damān and Diu
      • Nashik, Dādra and Nagar Haveli and Damān and Diu, India, 422001
        • Not yet recruiting
        • Local Institution - 0306
        • Contact:
          • Site 0306
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Not yet recruiting
        • Local Institution - 0305
        • Contact:
          • Site 0305
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Filippo Pietrantonio, Site 0163
          • Phone Number: 390223903807
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Silvia Foti, Site 0171
          • Phone Number: +390226437615
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
        • Contact:
          • Giampaolo Tortora, Site 0170
          • Phone Number: 390458128116
    • Campania
      • Naples, Campania, Italy, 80138
        • Recruiting
        • AOU della Campania Luigi Vanvitelli
        • Contact:
          • Ferdinando De Vita, Site 0167
          • Phone Number: 390815666713
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Not yet recruiting
        • Local Institution - 0166
        • Contact:
          • Site 0166
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
          • Sara Lonardi, Site 0168
          • Phone Number: 390498215910
  • Japan
      • Gifu, Japan, 501-1194
        • Recruiting
        • Gifu University Hospital
        • Contact:
          • Akitaka Makiyama, Site 0006
          • Phone Number: 000-000-0000
      • Minami-Ku, Fukuoka, Japan, 811-1347
        • Not yet recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Sendai, Japan, 980-8574
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
          • Yukiya Narita, Site 0013
          • Phone Number: 81527626111
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • Kohei Shitara, Site 0033
          • Phone Number: 81471331111
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Not yet recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2418515
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 710-8602
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Osaka
      • Osaka, Osaka, Japan, 5418567
        • Not yet recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital
        • Contact:
          • Noriko Wada, Site 0028
          • Phone Number: 81668795111
      • Takatsuki, Osaka, Japan, 569-8686
        • Not yet recruiting
        • Local Institution - 0376
        • Contact:
          • Site 0376
    • Shizuoka
      • Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
          • Hirokazu Shoji, Site 0003
          • Phone Number: 81335422511
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of JFCR
        • Contact:
          • Kensei Yamaguchi, Site 0008
          • Phone Number: 81335200111
  • Mexico
    • DIF
      • Mexico City, DIF, Mexico, 03100
        • Not yet recruiting
        • Local Institution - 0396
        • Contact:
          • Site 0396
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14000
        • Not yet recruiting
        • Local Institution - 0395
        • Contact:
          • Site 0395
      • Mexico City, Mexico City, Mexico, 14000
        • Not yet recruiting
        • Local Institution - 0397
        • Contact:
          • Site 0397
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Not yet recruiting
        • Local Institution - 0394
        • Contact:
          • Site 0394
  • Poland
      • Jelenia Góra, Poland, 58-506
        • Recruiting
        • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
        • Contact:
          • Katarzyna Wozniak, Site 0336
          • Phone Number: 48502051990
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 03-411
        • Recruiting
        • Mazowiecki Szpital Onkologiczny
        • Contact:
          • Joanna Omyla-Staszewska, Site 0339
          • Phone Number: 48227661500
      • Warsaw, Masovian Voivodeship, Poland, 02-034
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
        • Contact:
          • Lucjan Wyrwicz, Site 0361
          • Phone Number: 225709223
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-061
        • Recruiting
        • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
        • Contact:
          • Barbara Radecka, Site 0320
          • Phone Number: 48502313767
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj
        • Contact:
          • Tudor Ciuleanu, Site 0019
          • Phone Number: 40745646368
      • Iași, Romania, 700106
        • Recruiting
        • S.C. Centrul de Oncologie Euroclinic S.R.L.
        • Contact:
          • Constantin Volovat, Site 0021
          • Phone Number: 40746110096
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie
        • Contact:
          • Bogdan Gafton, Site 0005
          • Phone Number: 40766307558
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400162
        • Recruiting
        • Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
        • Contact:
          • Adrian Radu Vidra, Site 0010
          • Phone Number: +40724251696
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL
        • Contact:
          • Andrei Ungureanu, Site 0030
          • Phone Number: 40742206212
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"
        • Contact:
          • Michael Schenker, Site 0011
          • Phone Number: 40727774974
  • South Korea
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Keun-Wook Lee, Site 0034
          • Phone Number: 821041671676
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Do-Youn Oh, Site 0027
          • Phone Number: 82220720701
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • jeeyun Lee, Site 0001
          • Phone Number: +82-2-3410-6820
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Sun Young Rha, Site 0020
          • Phone Number: 82222288050
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Min-Hee Ryu, Site 0036
          • Phone Number: 82230105935
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Ana Custodio Carretero, Site 0360
          • Phone Number: 34917277516
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Javier Sastre Valera, Site 0358
          • Phone Number: 34620944068
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
          • Pilar Aitana Calvo Ferrandiz, Site 0389
          • Phone Number: 34914269519
      • Málaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General
        • Contact:
          • Inmaculada Ales Diaz, Site 0390
          • Phone Number: 34951291425
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0388
        • Contact:
          • Site 0388
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Fernando Rivera Herrero, Site 0350
          • Phone Number: +34654557483
    • Navarre
      • Pamplona, Navarre, Spain, 31009
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Maria Alsina Maqueda, Site 0391
          • Phone Number: 0034848422222
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hospital Clínico de Valencia
        • Contact:
          • TANIA FLEITAS, Site 0312
          • Phone Number: +34961973517
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Not yet recruiting
        • Local Institution - 0111
        • Contact:
          • Site 0111
      • Edirne, Turkey (Türkiye), 22030
        • Not yet recruiting
        • Local Institution - 0108
        • Contact:
          • Site 0108
      • Kadiköy/Istanbul, Turkey (Türkiye), 41380
        • Not yet recruiting
        • Local Institution - 0125
        • Contact:
          • Site 0125
      • Manisa, Turkey (Türkiye), 45030
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
      • Sakarya, Turkey (Türkiye), 54100
        • Not yet recruiting
        • Local Institution - 0128
        • Contact:
          • Site 0128
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Not yet recruiting
        • Local Institution - 0354
        • Contact:
          • Site 0354
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
          • Elizabeth Cartwright, Site 0357
          • Phone Number: 020 7811 8460
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Wasat Mansoor, Site 0331
          • Phone Number: 0161 446 8217
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Marco Gerlinger, Site 0316
          • Phone Number: 020 7377 7000
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Recruiting
        • Oxford University Hospitals NHS Trust
        • Contact:
          • Elizabeth Smyth, Site 0317
          • Phone Number: +44 300 304 7777
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
        • Contact:
          • Elizabeth Cartwright, Site 0444
          • Phone Number: 020 7811 8460
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Not yet recruiting
        • Local Institution - 0284
        • Contact:
          • Site 0284
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Contact:
          • Syma Iqbal, Site 0437
          • Phone Number: 310-994-2096
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center
        • Contact:
          • Farshid Dayyani, Site 0277
          • Phone Number: 714-456-5153
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • Local Institution - 0428
        • Contact:
          • Site 0428
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South
        • Contact:
          • Fadi Kayali, Site 0429
          • Phone Number: 239-274-9930
      • Jacksonville, Florida, United States, 32224
        • Not yet recruiting
        • Local Institution - 0433
        • Contact:
          • Site 0433
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Florida Cancer Specialists - North
        • Contact:
          • Muhammad Imam, Site 0430
          • Phone Number: 000-000-0000
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Allan Lima Pereira, Site 0246
          • Phone Number: 813-745-4436
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Contact:
          • Gideon T Dosunmu, Site 0377
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • Local Institution - 0379
        • Contact:
          • Site 0379
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • Local Institution - 0268
        • Contact:
          • Site 0268
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0259
        • Contact:
          • Site 0259
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • Missouri Cancer Associates
        • Contact:
          • John R. Ogden, Site 0426
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • Local Institution - 0286
        • Contact:
          • Site 0286
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/ RJ Zuckerberg Cancer Center
        • Contact:
          • Nicholas Hornstein, Site 0386
          • Phone Number: 323-533-7275
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Yelena Janjigian, Site 0242
          • Phone Number: 646-888-4186
      • Rochester, New York, United States, 14642
        • Not yet recruiting
        • Local Institution - 0274
        • Contact:
          • Site 0274
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • Local Institution - 0245
        • Contact:
          • Site 0245
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Local Institution - 0222
        • Contact:
          • Site 0222
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • Local Institution - 0443
        • Contact:
          • Site 0443
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates Of Oregon, Pc
        • Contact:
          • Marc Uemura, Site 0432
          • Phone Number: 541-214-8284
      • Portland, Oregon, United States, 97213-2982
        • Recruiting
        • Northwest Cancer Specialists, P.C.
        • Contact:
          • Spencer Shao, Site 0419
          • Phone Number: 503-528-5005
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
          • Anwaar Saeed, Site 0407
          • Phone Number: 816-898-9413
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Contact:
          • Brian Grieb, Site 0255
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Contact:
          • Meredith Pelster, Site 0417
          • Phone Number: 615-986-4366
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Texas Oncology - Amarillo Cancer Center
        • Contact:
          • Anton Melnyk, Site 0423
          • Phone Number: 325-692-0188
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology-Austin Central
        • Contact:
          • Vivian Cline, Site 0416
          • Phone Number: 512-427-9400
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Texas Oncology
        • Contact:
          • Pavel Levin, Site 0424
      • Denison, Texas, United States, 75020
        • Recruiting
        • Texas Oncology - Northeast Texas
        • Contact:
          • Amir Faridi, Site 0415
          • Phone Number: 000-000-0000
      • Grapevine, Texas, United States, 76051
        • Recruiting
        • Texas Oncology - DFW
        • Contact:
          • Ravi Patel, Site 0421
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Jaffer Ajani, Site 0233
          • Phone Number: 713-792-2828
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio
        • Contact:
          • John R. Ogden, Site 0427
    • Virginia
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
        • Contact:
          • Mark Kochenderfer, Site 0413
          • Phone Number: 540-982-0237
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
          • Nataliya Uboha, Site 0271
          • Phone Number: 608-265-9966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm C
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Folfox
Specified dose on specified days
Drug: Capox
Specified dose on specified days
Experimental: Arm D
Drug: Nivolumab
Specified dose on specified days
Drug: Folfox
Specified dose on specified days
Drug: Capox
Specified dose on specified days
Experimental: Arm A1
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Folfox
Specified dose on specified days
Drug: Capox
Specified dose on specified days
Experimental: Arm A2
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Folfox
Specified dose on specified days
Drug: Capox
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Phase 3
Up to approximately 33 months
Overall survival (OS)
Time Frame: Up to approximately 47 months
Phase 3
Up to approximately 47 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS by RECIST v1.1 per investigator assessment
Time Frame: Up to approximately 33 months
Phase 2
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
Phase 2
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
Phase 2
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
Phase 2
Up to approximately 33 months
Recommended dose of Pumitamig for Phase 3
Time Frame: Up to approximately 33 months
Phase 2
Up to approximately 33 months
Objective response (OR) by RECIST v1.1 per BICR
Time Frame: Up to approximately 33 months
Phase 3
Up to approximately 33 months
DOR by RECIST v1.1 per BICR
Time Frame: Up to approximately 33 months
Phase 3
Up to approximately 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

BioNTech SE

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2026

Primary Completion (Estimated)

November 8, 2030

Study Completion (Estimated)

September 11, 2032

Study Registration Dates

First Submitted

October 23, 2025

First Submitted That Met QC Criteria

October 23, 2025

First Posted (Actual)

October 27, 2025

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA266-0004
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523263-37 (Other Identifier: EU CTR)
  • U1111-1325-8116 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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