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)
NCT ID: NCT07221149
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
690 participants
INTERVENTIONAL
2026-03-09
2032-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A1
Pumitamig
Specified dose on specified days
Folfox
Specified dose on specified days
Arm A2
Pumitamig
Specified dose on specified days
Folfox
Specified dose on specified days
Arm B
Folfox
Specified dose on specified days
Nivolumab
Specified dose on specified days
Arm C
Pumitamig
Specified dose on specified days
Folfox
Specified dose on specified days
Capox
Specified dose on specified days
Arm D
Folfox
Specified dose on specified days
Capox
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Pumitamig
Specified dose on specified days
Folfox
Specified dose on specified days
Capox
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
* 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 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 prophylactic 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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0284
Phoenix, Arizona, United States
Local Institution - 0240
Los Angeles, California, United States
Local Institution - 0277
Orange, California, United States
Local Institution - 0428
San Francisco, California, United States
Local Institution - 0429
Fort Myers, Florida, United States
Local Institution - 0433
Jacksonville, Florida, United States
Local Institution - 0430
St. Petersburg, Florida, United States
Local Institution - 0246
Tampa, Florida, United States
Local Institution - 0377
Atlanta, Georgia, United States
Local Institution - 0379
Chicago, Illinois, United States
Local Institution - 0268
Iowa City, Iowa, United States
Local Institution - 0259
Rochester, Minnesota, United States
Local Institution - 0426
Columbia, Missouri, United States
Local Institution - 0286
Omaha, Nebraska, United States
Local Institution - 0386
Lake Success, New York, United States
Local Institution - 0242
New York, New York, United States
Local Institution - 0222
Cleveland, Ohio, United States
Local Institution - 0432
Eugene, Oregon, United States
Local Institution - 0419
Portland, Oregon, United States
Local Institution - 0407
Pittsburgh, Pennsylvania, United States
Local Institution - 0417
Nashville, Tennessee, United States
Local Institution - 0423
Amarillo, Texas, United States
Local Institution - 0416
Austin, Texas, United States
Local Institution - 0424
Beaumont, Texas, United States
Local Institution - 0415
Denison, Texas, United States
Local Institution - 0421
Grapevine, Texas, United States
Local Institution - 0233
Houston, Texas, United States
Local Institution - 0427
San Antonio, Texas, United States
Local Institution - 0413
Salem, Virginia, United States
Local Institution - 0271
Madison, Wisconsin, United States
Local Institution - 0061
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0066
ABB, Buenos Aires F.D., Argentina
Local Institution - 0069
Buenos Aires, , Argentina
Local Institution - 0054
Buenos Aires, , Argentina
Local Institution - 0080
Birtinya, Queensland, Australia
Local Institution - 0077
Elizabeth Vale, South Australia, Australia
Local Institution - 0085
Clayton, Victoria, Australia
Local Institution - 0400
Melbourne, Victoria, Australia
Local Institution - 0083
Perth, Western Australia, Australia
Local Institution - 0208
Fortaleza, Ceará, Brazil
Local Institution - 0204
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0226
Natal/RN, Rio Grande do Norte, Brazil
Local Institution - 0210
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0425
Santa Maria, Rio Grande do Sul, Brazil
Local Institution - 0221
São José do Rio Preto, , Brazil
Local Institution - 0088
Calgary, Alberta, Canada
Local Institution - 0119
Halifax, Nova Scotia, Canada
Local Institution - 0121
Toronto, Ontario, Canada
Local Institution - 0175
Sherbrooke, Quebec, Canada
Local Institution - 0068
Santiago, Santiago Metropolitan, Chile
Local Institution - 0056
Santiago, Santiago Metropolitan, Chile
Local Institution - 0055
Santiago, Santiago Metropolitan, Chile
Local Institution - 0410
Beijing, Beijing Municipality, China
Local Institution - 0418
Beijing, Beijing Municipality, China
Local Institution - 0276
Fuzhou, Fujian, China
Local Institution - 0232
Guangzhou, Guangdong, China
Local Institution - 0280
Guangzhou, Guangdong, China
Local Institution - 0231
Nanning, Guangxi, China
Local Institution - 0237
Harbin, Heilongjiang, China
Local Institution - 0282
Weihui, Henan, China
Local Institution - 0249
Zhengzhou, Henan, China
Local Institution - 0412
Wuhan, Hubei, China
Local Institution - 0279
Wuhan, Hubei, China
Local Institution - 0292
Changsha, Hunan, China
Local Institution - 0409
Nanchang, Jiangxi, China
Local Institution - 0244
Shenyang, Liaoning, China
Local Institution - 0266
Xi'an, Shaanxi, China
Local Institution - 0273
Jinan, Shandong, China
Local Institution - 0258
Shanghai, Shanghai Municipality, China
Local Institution - 0243
Taiyuan, Shanxi, China
Local Institution - 0260
Chengdu, Sichuan, China
Local Institution - 0248
Tianjin, Tianjin Municipality, China
Local Institution - 0408
Hangzhou, Zhejiang, China
Local Institution - 0252
Hangzhou, Zhejiang, China
Local Institution - 0269
Shanghai, , China
Local Institution - 0399
Pasto, Departamento de Nariño, Colombia
Local Institution - 0398
Cali, Valle del Cauca Department, Colombia
Local Institution - 0064
Brest, Finistère, France
Local Institution - 0062
Nantes, Pays de la Loire Region, France
Local Institution - 0051
Lille, , France
Local Institution - 0058
Lyon, , France
Local Institution - 0060
Marseille, , France
Local Institution - 0049
Paris, , France
Local Institution - 0046
Poitiers, , France
Local Institution - 0089
Berlin, , Germany
Local Institution - 0134
Frankfurt, , Germany
Local Institution - 0090
Hamburg, , Germany
Local Institution - 0100
Heidelberg, , Germany
Local Institution - 0112
Leipzig, , Germany
Local Institution - 0105
Mainz, , Germany
Local Institution - 0101
Mannheim, , Germany
Local Institution - 0117
Ulm, , Germany
Local Institution - 0306
Nashik, Dādra and Nagar Haveli and Damān and Diu, India
Local Institution - 0305
Mumbai, Maharashtra, India
Local Institution - 0404
Mumbai, Maharashtra, India
Local Institution - 0303
Delhi, , India
Local Institution - 0403
Delhi, , India
Local Institution - 0302
Puducherry, , India
Local Institution - 0310
Pune, , India
Local Institution - 0167
Napoli, Campania, Italy
Local Institution - 0171
Milan, , Italy
Local Institution - 0163
Milan, , Italy
Local Institution - 0168
Padua, , Italy
Local Institution - 0170
Roma, , Italy
Local Institution - 0166
Torino, , Italy
Local Institution - 0014
Chiba, Chiba, Japan
Local Institution - 0012
Matsuyama, Ehime, Japan
Local Institution - 0029
Kurashiki, Okayama-ken, Japan
Local Institution - 0004
Osaka, Osaka, Japan
Local Institution - 0028
Suita, Osaka, Japan
Local Institution - 0376
Takatsuki, Osaka, Japan
Local Institution - 0026
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Local Institution - 0003
Chuo-ku, Tokyo, Japan
Local Institution - 0008
Koto-ku, Tokyo, Japan
Local Institution - 0013
Chikusa-ku, , Japan
Local Institution - 0006
Gifu, , Japan
Local Institution - 0033
Kashiwa, , Japan
Local Institution - 0002
Minami-Ku, Fukuoka, , Japan
Local Institution - 0024
Sendai, , Japan
Local Institution - 0015
Yokohama, , Japan
Local Institution - 0396
Mexico City, DIF, Mexico
Local Institution - 0395
Mexico City, Mexico City, Mexico
Local Institution - 0397
Mexico City, Mexico City, Mexico
Local Institution - 0394
Oaxaca City, Oaxaca, Mexico
Local Institution - 0336
Jelenia Góra, Lower Silesian Voivodeship, Poland
Local Institution - 0339
Wieliszew, Masovian Voivodeship, Poland
Local Institution - 0342
Krakow, , Poland
Local Institution - 0361
Krakow, , Poland
Local Institution - 0320
Opole, , Poland
Local Institution - 0010
Cluj-Napoca, Cluj, Romania
Local Institution - 0019
Cluj-Napoca, , Romania
Local Institution - 0011
Craiova, , Romania
Local Institution - 0030
Floresti/ Cluj, , Romania
Local Institution - 0021
Iași, , Romania
Local Institution - 0005
Iași, , Romania
Local Institution - 0034
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0027
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0020
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0001
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0036
Seoul, Seoul-teukbyeolsi, South Korea
Local Institution - 0350
Santander, Cantabria, Spain
Local Institution - 0391
Pamplona, Navarre, Spain
Local Institution - 0312
Valencia, Valenciana, Comunitat, Spain
Local Institution - 0389
Madrid, , Spain
Local Institution - 0358
Madrid, , Spain
Local Institution - 0360
Madrid, , Spain
Local Institution - 0390
Málaga, , Spain
Local Institution - 0111
Ankara, , Turkey (Türkiye)
Local Institution - 0108
Edirne, , Turkey (Türkiye)
Local Institution - 0125
Kadiköy/Istanbul, , Turkey (Türkiye)
Local Institution - 0093
Manisa, , Turkey (Türkiye)
Local Institution - 0128
Sakarya, , Turkey (Türkiye)
Local Institution - 0176
Southampton, Hampshire, United Kingdom
Local Institution - 0331
Manchester, Lancashire, United Kingdom
Local Institution - 0316
London, London, City of, United Kingdom
Local Institution - 0317
Oxford, Oxfordshire, United Kingdom
Local Institution - 0354
Glasgow, , United Kingdom
Local Institution - 0357
Sutton, , United Kingdom
Countries
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Central Contacts
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First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0284
Role: primary
Site 0240
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Site 0277
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Site 0428
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Site 0429
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Site 0433
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Site 0430
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Site 0246
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Site 0377
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Site 0379
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Site 0268
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Site 0259
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Site 0426
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Site 0286
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Site 0386
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Site 0242
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Site 0222
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Site 0432
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Site 0419
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Site 0407
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Site 0417
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Site 0423
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Site 0416
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Site 0424
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Site 0415
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Site 0421
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Site 0233
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Site 0427
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Site 0413
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Site 0271
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Site 0061
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Site 0066
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Site 0069
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Site 0054
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Site 0080
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Site 0077
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Site 0085
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Site 0400
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Site 0083
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Site 0208
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Site 0204
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Site 0226
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Site 0210
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Site 0425
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Site 0221
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Site 0088
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Site 0119
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Site 0121
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Site 0175
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Site 0068
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Site 0056
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Site 0055
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Site 0410
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Site 0418
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Site 0276
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Site 0232
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Site 0280
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Site 0231
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Site 0237
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Site 0282
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Site 0249
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Site 0412
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Site 0279
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Site 0292
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Site 0409
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Site 0244
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Site 0266
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Site 0273
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Site 0258
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Site 0243
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Site 0260
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Site 0248
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Site 0408
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Site 0252
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Site 0269
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Site 0399
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Site 0398
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Site 0064
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Site 0062
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Site 0051
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Site 0058
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Site 0060
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Site 0049
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Site 0046
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Site 0089
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Site 0134
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Site 0090
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Site 0100
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Site 0112
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Site 0105
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Site 0101
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Site 0117
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Site 0306
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Site 0305
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Site 0404
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Site 0303
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Site 0403
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Site 0302
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Site 0310
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Site 0167
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Site 0171
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Site 0163
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Site 0168
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Site 0170
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Site 0166
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Site 0014
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Site 0012
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Site 0029
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Site 0004
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Site 0028
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Site 0376
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Site 0026
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Site 0003
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Site 0008
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Site 0013
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Site 0006
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Site 0033
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Site 0002
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Site 0024
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Site 0015
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Site 0396
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Site 0395
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Site 0397
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Site 0394
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Site 0336
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Site 0339
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Site 0342
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Site 0361
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Site 0320
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Site 0010
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Site 0019
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Site 0011
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Site 0030
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Site 0021
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Site 0005
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Site 0034
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Site 0027
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Site 0020
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Site 0001
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Site 0036
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Site 0350
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Site 0391
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Site 0312
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Site 0389
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Site 0358
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Site 0360
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Site 0390
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Site 0111
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Site 0108
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Site 0125
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Site 0093
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Site 0128
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Site 0176
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Site 0331
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Site 0316
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Site 0317
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Site 0354
Role: primary
Site 0357
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-523263-37
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1325-8116
Identifier Type: OTHER
Identifier Source: secondary_id
CA266-0004
Identifier Type: -
Identifier Source: org_study_id
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