Actively Recruiting
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)
Led by Bristol-Myers Squibb · Updated on 2026-05-14
690
Participants Needed
162
Research Sites
339 weeks
Total Duration
On this page
Sponsors
B
Bristol-Myers Squibb
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated with systemic treatment for advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
- Histologically or cytologically confirmed advanced or metastatic gastric cancer, gastroesophageal junction adenocarcinoma, or distal esophageal adenocarcinoma
- Documented PD-L1 status (≥ 1 or < 1) for Phase 2, PD-L1 ≥ 1 for Phase 3
- Documented HER2-negative cancer as per local guidelines
- Measurable disease by RECIST v1.1
You will not qualify if you...
- Untreated known central nervous system metastases
- Significant cardiovascular disease within 6 months, including myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident, uncontrolled hypertension, or congenital long QT syndrome
- Major coagulation disorders such as hemophilia
- History of deep vein thrombosis, pulmonary embolism, or significant thromboembolism within 3 months unless fully treated and stabilized
- History of abdominal fistula or gastrointestinal perforation within 6 months
- Major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipated major surgery during study
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 162 locations
1
Local Institution - 0284
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Local Institution - 0437
Los Angeles, California, United States, 90033
Not Yet Recruiting
3
Local Institution - 0277
Orange, California, United States, 92868
Not Yet Recruiting
4
Local Institution - 0428
San Francisco, California, United States, 94158
Not Yet Recruiting
5
Florida Cancer Specialists - South
Fort Myers, Florida, United States, 33901
Actively Recruiting
6
Local Institution - 0433
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
7
Florida Cancer Specialists - North
St. Petersburg, Florida, United States, 33701
Actively Recruiting
8
Local Institution - 0246
Tampa, Florida, United States, 33612
Not Yet Recruiting
9
Local Institution - 0377
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
10
Local Institution - 0379
Chicago, Illinois, United States, 60637
Not Yet Recruiting
11
Local Institution - 0268
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
12
Local Institution - 0259
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
13
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
14
Local Institution - 0286
Omaha, Nebraska, United States, 68198
Not Yet Recruiting
15
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States, 11042
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
Local Institution - 0274
Rochester, New York, United States, 14642
Not Yet Recruiting
18
Local Institution - 0245
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
19
Local Institution - 0443
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
20
Local Institution - 0222
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
21
Oncology Associates Of Oregon, Pc
Eugene, Oregon, United States, 97401
Actively Recruiting
22
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97213-2982
Actively Recruiting
23
Local Institution - 0407
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
24
Local Institution - 0255
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
25
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, United States, 79124
Actively Recruiting
27
Texas Oncology-Austin Central
Austin, Texas, United States, 78731
Actively Recruiting
28
Texas Oncology
Beaumont, Texas, United States, 77702
Actively Recruiting
29
Texas Oncology - Northeast Texas
Denison, Texas, United States, 75020
Actively Recruiting
30
Texas Oncology - DFW
Grapevine, Texas, United States, 76051
Actively Recruiting
31
Local Institution - 0233
Houston, Texas, United States, 77030
Not Yet Recruiting
32
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
33
Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
Salem, Virginia, United States, 24153
Actively Recruiting
34
Local Institution - 0271
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
35
Local Institution - 0061
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Not Yet Recruiting
36
Local Institution - 0066
ABB, Buenos Aires F.D., Argentina, C1199ABB
Not Yet Recruiting
37
Local Institution - 0069
Buenos Aires, Argentina, 1039
Not Yet Recruiting
38
Local Institution - 0054
Buenos Aires, Argentina, C1431FWO
Not Yet Recruiting
39
Local Institution - 0176
Liverpool, New South Wales, Australia, 2170
Not Yet Recruiting
40
Local Institution - 0080
Birtinya, Queensland, Australia, 4575
Not Yet Recruiting
41
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Actively Recruiting
42
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
43
Warringal Medical Centre
Melbourne, Victoria, Australia, 3084
Actively Recruiting
44
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
45
Local Institution - 0208
Fortaleza, Ceará, Brazil, 60115-280
Not Yet Recruiting
46
Local Institution - 0204
Belo Horizonte, Minas Gerais, Brazil, 30140-073
Not Yet Recruiting
47
Local Institution - 0226
Natal/RN, Rio Grande do Norte, Brazil, 59062-000
Not Yet Recruiting
48
Local Institution - 0210
Porto Alegre, Rio Grande do Sul, Brazil, 80035-903
Not Yet Recruiting
49
Local Institution - 0425
Santa Maria, Rio Grande do Sul, Brazil, 97015-373
Not Yet Recruiting
50
Local Institution - 0221
São José do Rio Preto, Brazil, 15090-000
Not Yet Recruiting
51
Local Institution - 0088
Calgary, Alberta, Canada, T2N 5G2
Not Yet Recruiting
52
Local Institution - 0119
Halifax, Nova Scotia, Canada, B3H 3A7
Not Yet Recruiting
53
Local Institution - 0121
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
54
Local Institution - 0175
Sherbrooke, Quebec, Canada, J1H 5N4
Not Yet Recruiting
55
Local Institution - 0068
Santiago, Santiago Metropolitan, Chile, 7500921
Not Yet Recruiting
56
Local Institution - 0056
Santiago, Santiago Metropolitan, Chile, 7710007
Not Yet Recruiting
57
Local Institution - 0055
Santiago, Santiago Metropolitan, Chile, 8420383
Not Yet Recruiting
58
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
59
Local Institution - 0276
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
60
Local Institution - 0232
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
61
Local Institution - 0280
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
62
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China, 530200
Actively Recruiting
63
Local Institution - 0237
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
64
Local Institution - 0282
Weihui, Henan, China, 453100
Not Yet Recruiting
65
Local Institution - 0249
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
66
Local Institution - 0279
Wuhan, Hubei, China, 430079
Not Yet Recruiting
67
Local Institution - 0292
Changsha, Hunan, China, 410031
Not Yet Recruiting
68
Local Institution - 0256
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
69
Local Institution - 0440
Yangzhou, Jiangsu, China, 225001
Not Yet Recruiting
70
Local Institution - 0409
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
71
Local Institution - 0244
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
72
Local Institution - 0273
Jinan, Shandong, China, 250117
Not Yet Recruiting
73
Local Institution - 0258
Shanghai, Shanghai Municipality, China, 200120
Not Yet Recruiting
74
Local Institution - 0243
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
75
Local Institution - 0260
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
76
Local Institution - 0248
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
77
Local Institution - 0408
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
78
Local Institution - 0252
Hangzhou, Zhejiang, China, 310052
Not Yet Recruiting
79
Local Institution - 0269
Shanghai, China, 200032
Not Yet Recruiting
80
Local Institution - 0399
Pasto, Departamento de Nariño, Colombia, 520001
Not Yet Recruiting
81
Local Institution - 0398
Cali, Valle del Cauca Department, Colombia, 760032
Not Yet Recruiting
82
Local Institution - 0058
Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
Not Yet Recruiting
83
CHRU de Brest
Brest, Finistère, France, 29609
Actively Recruiting
84
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France, 59000
Actively Recruiting
85
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
86
Local Institution - 0046
Poitiers, Vienne, France, 86021
Not Yet Recruiting
87
Local Institution - 0060
Marseille, France, 13385
Not Yet Recruiting
88
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
89
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany, 10117
Actively Recruiting
90
Krankenhaus Nordwest GmbH
Frankfurt, Germany, 60488
Actively Recruiting
91
Facharztzentrum Eppendorf
Hamburg, Germany, 20249
Actively Recruiting
92
Nationales Centrum Fur Tumorerkrankungen (Nct)
Heidelberg, Germany, 69120
Actively Recruiting
93
Local Institution - 0112
Leipzig, Germany, 04103
Not Yet Recruiting
94
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany, 55131
Actively Recruiting
95
Local Institution - 0101
Mannheim, Germany, 68167
Not Yet Recruiting
96
Local Institution - 0117
Ulm, Germany, 89081
Not Yet Recruiting
97
Local Institution - 0306
Nashik, Dādra and Nagar Haveli and Damān and Diu, India, 422001
Not Yet Recruiting
98
Local Institution - 0305
Mumbai, Maharashtra, India, 400012
Not Yet Recruiting
99
Local Institution - 0303
Delhi, India, 110029
Not Yet Recruiting
100
Local Institution - 0403
Delhi, India, 110029
Not Yet Recruiting
101
Local Institution - 0302
Puducherry, India, 605006
Not Yet Recruiting
102
Local Institution - 0310
Pune, India, 411001
Not Yet Recruiting
103
Local Institution - 0167
Naples, Campania, Italy, 80138
Not Yet Recruiting
104
Local Institution - 0166
Turin, Piedmont, Italy, 10126
Not Yet Recruiting
105
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
106
Local Institution - 0163
Milan, Italy, 20133
Not Yet Recruiting
107
Local Institution - 0168
Padova, Italy, 35128
Not Yet Recruiting
108
Local Institution - 0170
Roma, Italy, 00168
Not Yet Recruiting
109
Local Institution - 0014
Chiba, Chiba, Japan, 260-8717
Not Yet Recruiting
110
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
111
Local Institution - 0012
Matsuyama, Ehime, Japan, 791-0280
Not Yet Recruiting
112
Local Institution - 0015
Yokohama, Kanagawa, Japan, 2418515
Not Yet Recruiting
113
Local Institution - 0029
Kurashiki, Okayama-ken, Japan, 710-8602
Not Yet Recruiting
114
Local Institution - 0004
Osaka, Osaka, Japan, 5418567
Not Yet Recruiting
115
The University of Osaka Hospital
Suita, Osaka, Japan, 565-0871
Actively Recruiting
116
Local Institution - 0376
Takatsuki, Osaka, Japan, 569-8686
Not Yet Recruiting
117
Local Institution - 0026
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Not Yet Recruiting
118
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
119
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
120
Local Institution - 0013
Chikusa-ku, Japan, 464-8681
Not Yet Recruiting
121
Local Institution - 0006
Gifu, Japan, 501-1194
Not Yet Recruiting
122
Local Institution - 0002
Minami-Ku, Fukuoka, Japan, 811-1347
Not Yet Recruiting
123
Local Institution - 0024
Sendai, Japan, 980-8574
Not Yet Recruiting
124
Local Institution - 0396
Mexico City, DIF, Mexico, 03100
Not Yet Recruiting
125
Local Institution - 0395
Mexico City, Mexico City, Mexico, 14000
Not Yet Recruiting
126
Local Institution - 0397
Mexico City, Mexico City, Mexico, 14000
Not Yet Recruiting
127
Local Institution - 0394
Oaxaca City, Oaxaca, Mexico, 68020
Not Yet Recruiting
128
Local Institution - 0336
Jelenia Góra, Lower Silesian Voivodeship, Poland, 58-506
Not Yet Recruiting
129
Local Institution - 0339
Wieliszew, Masovian Voivodeship, Poland, 05-135
Not Yet Recruiting
130
Local Institution - 0342
Gliwice, Silesian Voivodeship, Poland, 44-101
Not Yet Recruiting
131
Local Institution - 0361
Krakow, Poland, 31-115
Not Yet Recruiting
132
Local Institution - 0320
Opole, Poland, 45-372
Not Yet Recruiting
133
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj, Romania, 400162
Actively Recruiting
134
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania, 407280
Actively Recruiting
135
Institutul Oncologic Cluj
Cluj-Napoca, Romania, 400015
Actively Recruiting
136
Local Institution - 0011
Craiova, Romania, 200347
Not Yet Recruiting
137
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, Romania, 700106
Actively Recruiting
138
Institutul Regional de Oncologie
Iași, Romania, 700483
Actively Recruiting
139
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea, 13620
Actively Recruiting
140
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
Actively Recruiting
141
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
Actively Recruiting
142
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
Actively Recruiting
143
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Actively Recruiting
144
Local Institution - 0388
Barcelona, Barcelona [Barcelona], Spain, 08035
Not Yet Recruiting
145
Local Institution - 0350
Santander, Cantabria, Spain, 39008
Not Yet Recruiting
146
Local Institution - 0391
Pamplona, Navarre, Spain, 31009
Not Yet Recruiting
147
Local Institution - 0312
Valencia, Valenciana, Comunitat, Spain, 46010
Not Yet Recruiting
148
Local Institution - 0389
Madrid, Spain, 28028
Not Yet Recruiting
149
Local Institution - 0358
Madrid, Spain, 28040
Not Yet Recruiting
150
Local Institution - 0360
Madrid, Spain, 28046
Not Yet Recruiting
151
H.R.U Málaga - Hospital General
Málaga, Spain, 29011
Actively Recruiting
152
Local Institution - 0111
Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
153
Local Institution - 0108
Edirne, Turkey (Türkiye), 22030
Not Yet Recruiting
154
Local Institution - 0125
Kadiköy/Istanbul, Turkey (Türkiye), 41380
Not Yet Recruiting
155
Local Institution - 0093
Manisa, Turkey (Türkiye), 45030
Not Yet Recruiting
156
Local Institution - 0128
Sakarya, Turkey (Türkiye), 54100
Not Yet Recruiting
157
St Bartholomew's Hospital
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
158
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Actively Recruiting
159
Local Institution - 0354
Glasgow, United Kingdom, G12 0YN
Not Yet Recruiting
160
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
161
Local Institution - 0357
Sutton, United Kingdom, SM2 5PT
Not Yet Recruiting
162
Local Institution - 0300
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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