Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal AdenocarcinomaPhase 2/3NCT07221149
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)
A Phase 2/3 study testing Pumitamig, Folfox and Capox in people with Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, run by Bristol-Myers Squibb at 161 sites in 21 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
- What is being tested?
- Pumitamig, Folfox and Capox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 161 sitesin 21 countries
- Study dates
- 13 Mar 2026to 11 Sep 2032
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
161 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
161 sites in 21 countries
United States34 sites, 34 recruiting
- Recruiting
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, 79124
Anton Melnyk, Site 0423, 325-692-0188
- Recruiting
Emory University
Atlanta, Georgia, 30308
Gideon T Dosunmu, Site 0377
- Recruiting
Texas Oncology-Austin Central
Austin, Texas, 78731
Vivian Cline, Site 0416, 512-427-9400
- Recruiting
Texas Oncology
Beaumont, Texas, 77702
Pavel Levin, Site 0424
- Recruiting
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Brent Hanks, Site 0245
- Not yet recruiting
Local Institution - 0379
Chicago, Illinois, 60637
Site 0379
- Not yet recruiting
Local Institution - 0443
Cleveland, Ohio, 44106
Site 0443
- Not yet recruiting
Local Institution - 0222
Cleveland, Ohio, 44195
Site 0222
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
John R. Ogden, Site 0426
- Recruiting
Texas Oncology - Northeast Texas
Denison, Texas, 75020
Amir Faridi, Site 0415, 000-000-0000
- Recruiting
Oncology Associates Of Oregon, Pc
Eugene, Oregon, 97401
Marc Uemura, Site 0432, 541-214-8284
- Recruiting
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Fadi Kayali, Site 0429, 239-274-9930
- Recruiting
Texas Oncology - DFW
Grapevine, Texas, 76051
Ravi Patel, Site 0421
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jaffer Ajani, Site 0233, 713-792-2828
- Not yet recruiting
Local Institution - 0268
Iowa City, Iowa, 52242
Site 0268
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Conor O'Donnell, Site 0433, 904-953-2000
- Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Nicholas Hornstein, Site 0386, 323-533-7275
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Syma Iqbal, Site 0437, 310-994-2096
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Nataliya Uboha, Site 0271, 608-265-9966
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Meredith Pelster, Site 0417, 615-986-4366
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Brian Grieb, Site 0255
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Yelena Janjigian, Site 0242, 646-888-4186
- Not yet recruiting
Local Institution - 0286
Omaha, Nebraska, 68198
Site 0286
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Farshid Dayyani, Site 0277, 714-456-5153
- Recruiting
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
Mohamad Sonbol, Site 0284, 480-301-8000
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Anwaar Saeed, Site 0407, 816-898-9413
- Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213-2982
Spencer Shao, Site 0419, 503-528-5005
- Recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Ben George, Site 0259, 507-284-2511
- Not yet recruiting
Local Institution - 0274
Rochester, New York, 14642
Site 0274
- Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
Salem, Virginia, 24153
Mark Kochenderfer, Site 0413, 540-982-0237
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78240
John R. Ogden, Site 0427
- Not yet recruiting
Local Institution - 0428
San Francisco, California, 94158
Site 0428
- Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, 33701
Muhammad Imam, Site 0430, 000-000-0000
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Allan Lima Pereira, Site 0246, 813-745-4436
China22 sites, 22 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Site 0418, 13911219511
- Not yet recruiting
Local Institution - 0292
Changsha, Hunan, 410031
Site 0292
- Not yet recruiting
Local Institution - 0260
Chengdu, Sichuan, 610041
Site 0260
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yigui Chen, Site 0276, 8613509339525
- Not yet recruiting
Local Institution - 0232
Guangzhou, Guangdong, 510000
Site 0232
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, Site 0280, 8613925106525
- Not yet recruiting
Local Institution - 0408
Hangzhou, Zhejiang, 310003
Site 0408
- Not yet recruiting
Local Institution - 0252
Hangzhou, Zhejiang, 310052
Site 0252
- Not yet recruiting
Local Institution - 0237
Harbin, Heilongjiang, 150081
Site 0237
- Not yet recruiting
Local Institution - 0273
Jinan, Shandong, 250117
Site 0273
- Not yet recruiting
Local Institution - 0409
Nanchang, Jiangxi, 330006
Site 0409
- Not yet recruiting
Local Institution - 0256
Nanjing, Jiangsu, 210009
Site 0256
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530200
Yongqiang Li, Site 0231, 13457161928
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Yong Gao, Site 0258, 8613310167477
- Not yet recruiting
Local Institution - 0269
Shanghai, 200032
Site 0269
- Not yet recruiting
Local Institution - 0244
Shenyang, Liaoning, 110042
Site 0244
- Not yet recruiting
Local Institution - 0243
Taiyuan, Shanxi, 030001
Site 0243
- Not yet recruiting
Local Institution - 0248
Tianjin, Tianjin Municipality, 300060
Site 0248
- Not yet recruiting
Local Institution - 0282
Weihui, Henan, 453100
Site 0282
- Not yet recruiting
Local Institution - 0279
Wuhan, Hubei, 430079
Site 0279
- Not yet recruiting
Local Institution - 0440
Yangzhou, Jiangsu, 225001
Site 0440
- Not yet recruiting
Local Institution - 0249
Zhengzhou, Henan, 450008
Site 0249
Japan15 sites, 15 recruiting
- Not yet recruiting
Local Institution - 0014
Chiba, Chiba, 260-8717
Site 0014
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Hirokazu Shoji, Site 0003, 81335422511
- Recruiting
Gifu University Hospital
Gifu, 501-1194
Akitaka Makiyama, Site 0006, 000-000-0000
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Kohei Shitara, Site 0033, 81471331111
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kensei Yamaguchi, Site 0008, 81335200111
- Not yet recruiting
Local Institution - 0029
Kurashiki, Okayama-ken, 710-8602
Site 0029
- Not yet recruiting
Local Institution - 0012
Matsuyama, Ehime, 791-0280
Site 0012
- Not yet recruiting
Local Institution - 0002
Minami-Ku, Fukuoka, 811-1347
Site 0002
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Takeshi Kawakami, Site 0026, 81559895222
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Yukiya Narita, Site 0013, 81527626111
- Not yet recruiting
Local Institution - 0004
Osaka, Osaka, 5418567
Site 0004
- Not yet recruiting
Local Institution - 0024
Sendai, 980-8574
Site 0024
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
Noriko Wada, Site 0028, 81668795111
- Not yet recruiting
Local Institution - 0376
Takatsuki, Osaka, 569-8686
Site 0376
- Not yet recruiting
Local Institution - 0015
Yokohama, Kanagawa, 2418515
Site 0015
Germany8 sites, 8 recruiting
- Recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
Annika Kurreck, Site 0089, +4930450657306
- Recruiting
Krankenhaus Nordwest GmbH
Frankfurt, 60488
Thorsten Goetze, Site 0134, 496976014187
- Recruiting
Facharztzentrum Eppendorf
Hamburg, 20249
Alexander Stein, Site 0090, 494036035220
- Recruiting
Nationales Centrum Fur Tumorerkrankungen (Nct)
Heidelberg, 69120
Georg Haag, Site 0100, 4962215637630
- Not yet recruiting
Local Institution - 0112
Leipzig, 04103
Site 0112
- Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
Markus Moehler, Site 0105, 496131176076
- Recruiting
Universitätsmedizin Mannheim
Mannheim, 68167
Ralf-Dieter Hofheinz, Site 0101, +496213832488
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Thomas Seufferlein, Site 0117, 4973150044500
Spain8 sites, 8 recruiting
- Not yet recruiting
Local Institution - 0388
Barcelona, Barcelona [Barcelona], 08035
Site 0388
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Pilar Aitana Calvo Ferrandiz, Site 0389, 34914269519
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Javier Sastre Valera, Site 0358, 34620944068
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Ana Custodio Carretero, Site 0360, 34917277516
- Recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
Inmaculada Ales Diaz, Site 0390, 34951291425
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31009
Maria Alsina Maqueda, Site 0391, 0034848422222
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Fernando Rivera Herrero, Site 0350, +34654557483
- Recruiting
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
TANIA FLEITAS, Site 0312, +34961973517
France7 sites, 7 recruiting
- Recruiting
CHRU de Brest
Brest, Finistère, 29609
Jean-Philippe Metges, Site 0064, 33298223428
- Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59000
Anthony Turpin, Site 0051, +33320445461
- Recruiting
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Clelia Coutzac, Site 0058, +33478785992
- Not yet recruiting
Local Institution - 0060
Marseille, 13385
Site 0060
- Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, 44093
Yann Touchefeu, Site 0062, 33240083163
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Aziz Zaanan, Site 0049, 33156095064
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021
David Tougeron, Site 0046, 33549444951
Australia6 sites, 6 recruiting
- Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Michael Allen, Site 0080, +61752021111
- Recruiting
Monash Health
Clayton, Victoria, 3168
David Lau, Site 0085, (03)95946666
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Anas Alawawdeh, Site 0077, 0881829000
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Aflah Roohullah, Site 0176, 0472877240
- Recruiting
Warringal Medical Centre
Melbourne, Victoria, 3084
Niall Tebbutt, Site 0400, 0410582006
- Recruiting
St. John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Kynan Feeney, Site 0083, +61894389599
Brazil6 sites, 6 recruiting
- Recruiting
Centro de Investigação Clínica Ciências Médicas
Belo Horizonte, Minas Gerais, 30140-085
Gabriela Freitas Chaves, Site 0204
- Recruiting
Núcleo de Oncologia e Hematologia do Ceará
Fortaleza, Ceará, 60115-281
José Rocha, Site 0208, 85999872264
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Sulene Oliveira, Site 0226, 5584991191032
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Sergio Azevedo, Site 0210, 351222055700
- Recruiting
Clinica Viver
Santa Maria, Rio Grande do Sul, 97015-373
Luis Carlos Moreira Antunes, Site 0425
- Recruiting
Faculdade de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Kathia Abdalla, Site 0221, +551733216638
Italy6 sites, 6 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Filippo Pietrantonio, Site 0163, 390223903807
- Recruiting
Ospedale San Raffaele
Milan, 20132
Silvia Foti, Site 0171, +390226437615
- Recruiting
AOU della Campania Luigi Vanvitelli
Naples, Campania, 80138
Ferdinando De Vita, Site 0167, 390815666713
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
Sara Lonardi, Site 0168, 390498215910
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Giampaolo Tortora, Site 0170, 390458128116
- Not yet recruiting
Local Institution - 0166
Turin, Piedmont, 10126
Site 0166
Romania6 sites, 6 recruiting
- Recruiting
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj, 400162
Adrian Radu Vidra, Site 0010, +40724251696
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0019, 40745646368
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
Michael Schenker, Site 0011, 40727774974
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
Andrei Ungureanu, Site 0030, 40742206212
- Recruiting
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106
Constantin Volovat, Site 0021, 40746110096
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Bogdan Gafton, Site 0005, 40766307558
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0354
Glasgow, G12 0YN
Site 0354
- Recruiting
St Bartholomew's Hospital
London, London, City of, EC1A 7BE
Marco Gerlinger, Site 0316, 020 7377 7000
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
Elizabeth Cartwright, Site 0357, 020 7811 8460
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Wasat Mansoor, Site 0331, 0161 446 8217
- Recruiting
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LJ
Elizabeth Smyth, Site 0317, +44 300 304 7777
- Recruiting
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
Sutton, Surrey, SM2 5PT
Elizabeth Cartwright, Site 0444, 020 7811 8460
India5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0403
Delhi, 110029
Site 0403
- Not yet recruiting
Local Institution - 0305
Mumbai, Maharashtra, 400012
Site 0305
- Not yet recruiting
Local Institution - 0306
Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001
Site 0306
- Not yet recruiting
Local Institution - 0302
Puducherry, 605006
Site 0302
- Not yet recruiting
Local Institution - 0310
Pune, 411001
Site 0310
South Korea5 sites, 5 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Keun-Wook Lee, Site 0034, 821041671676
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Do-Youn Oh, Site 0027, 82220720701
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Sun Young Rha, Site 0020, 82222288050
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Min-Hee Ryu, Site 0036, 82230105935
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
jeeyun Lee, Site 0001, +82-2-3410-6820
Turkey (Türkiye)5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0111
Ankara, 06230
Site 0111
- Not yet recruiting
Local Institution - 0108
Edirne, 22030
Site 0108
- Not yet recruiting
Local Institution - 0125
Kadiköy/Istanbul, 41380
Site 0125
- Not yet recruiting
Local Institution - 0093
Manisa, 45030
Site 0093
- Not yet recruiting
Local Institution - 0128
Sakarya, 54100
Site 0128
Argentina4 sites, 4 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Maria Alicia Verzura, Site 0066, 54111555960279
- Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO
Julieta Grasselli, Site 0054, 541158826679
- Recruiting
Centro Médico Fleischer
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414
Guillermo Mendez, Site 0069, +5491162691673
- Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Federico Esteso, Site 0061, 01132218900
Canada4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0088
Calgary, Alberta, T2N 5G2
Site 0088
- Not yet recruiting
Local Institution - 0119
Halifax, Nova Scotia, B3H 3A7
Site 0119
- Not yet recruiting
Local Institution - 0175
Sherbrooke, Quebec, J1H 5N4
Site 0175
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Elena Elimova, Site 0121, 4169464501ext.2520
Mexico4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0396
Mexico City, DIF, 03100
Site 0396
- Not yet recruiting
Local Institution - 0395
Mexico City, Mexico City, 14000
Site 0395
- Not yet recruiting
Local Institution - 0397
Mexico City, Mexico City, 14000
Site 0397
- Not yet recruiting
Local Institution - 0394
Oaxaca City, Oaxaca, 68020
Site 0394
Poland4 sites, 4 recruiting
- Recruiting
Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej
Jelenia Góra, 58-506
Katarzyna Wozniak, Site 0336, 48502051990
- Recruiting
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Opole Voivodeship, 45-061
Barbara Radecka, Site 0320, 48502313767
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-034
Lucjan Wyrwicz, Site 0361, 225709223
- Recruiting
Mazowiecki Szpital Onkologiczny
Warsaw, Masovian Voivodeship, 03-411
Joanna Omyla-Staszewska, Site 0339, 48227661500
Chile3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0068
Santiago, Santiago Metropolitan, 7500921
Site 0068
- Not yet recruiting
Local Institution - 0056
Santiago, Santiago Metropolitan, 7710007
Site 0056
- Not yet recruiting
Local Institution - 0055
Santiago, Santiago Metropolitan, 8420383
Site 0055
Colombia2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0398
Cali, Valle del Cauca Department, 760032
Site 0398
- Not yet recruiting
Local Institution - 0399
Pasto, Departamento de Nariño, 520001
Site 0399
Location not given1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0300
Site 0300
About this study
Official 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
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
- Being tested
- Pumitamig, Folfox, Capox, Nivolumab
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BMS-986545, BNT327, PM8002
Specified dose on specified days
FolfoxDrug
Specified dose on specified days
CapoxDrug
Specified dose on specified days
NivolumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | Experimental | Not described Receives: Drug: Pumitamig; Drug: Folfox; Drug: Capox |
| Arm A2 | Experimental | Not described Receives: Drug: Pumitamig; Drug: Folfox; Drug: Capox |
| Arm C | Experimental | Not described Receives: Drug: Pumitamig; Drug: Folfox; Drug: Capox |
| Arm D | Experimental | Not described Receives: Drug: Folfox; Drug: Capox; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to approximately 33 months
Overall survival (OS)
Phase 3
Measured: Up to approximately 47 months
Secondary outcomes (7)
PFS by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to approximately 33 months
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to approximately 33 months
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Measured: 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
Measured: Up to approximately 33 months
Recommended dose of Pumitamig for Phase 3
Phase 2
Measured: Up to approximately 33 months
Objective response (OR) by RECIST v1.1 per BICR
Phase 3
Measured: Up to approximately 33 months
DOR by RECIST v1.1 per BICR
Phase 3
Measured: Up to approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start13 Mar 2026
- Primary completion8 Nov 2030 (estimated)
- Study completion11 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221149
- Sponsor's protocol ID
- CA266-0004
- Other IDs
- 2025-523263-37, U1111-1325-8116, 2025
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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