A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
NCT ID: NCT07221357
Last Updated: 2026-01-13
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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RECRUITING
PHASE2/PHASE3
990 participants
INTERVENTIONAL
2025-12-31
2034-03-11
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
FOLFIRI
Specified dose on specified days
Arm A2
Pumitamig
Specified dose on specified days
FOLFOX
Specified dose on specified days
FOLFIRI
Specified dose on specified days
Arm B
FOLFOX
Specified dose on specified days
FOLFIRI
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Arm C
Pumitamig
Specified dose on specified days
FOLFOX
Specified dose on specified days
FOLFIRI
Specified dose on specified days
CAPOX
Specified dose on specified days
Arm D
FOLFOX
Specified dose on specified days
FOLFIRI
Specified dose on specified days
Bevacizumab
Specified dose on specified days
CAPOX
Specified dose on specified days
Interventions
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Pumitamig
Specified dose on specified days
FOLFOX
Specified dose on specified days
FOLFIRI
Specified dose on specified days
Bevacizumab
Specified dose on specified days
CAPOX
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
* Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
* Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
* Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
* Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or 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.
* Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
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 - 0263
Los Angeles, California, United States
Local Institution - 0345
Orange, California, United States
Local Institution - 0317
San Francisco, California, United States
Local Institution - 0330
Santa Monica, California, United States
Local Institution - 0293
Stanford, California, United States
Local Institution - 0574
Cape Coral, Florida, United States
Local Institution - 0575
St. Petersburg, Florida, United States
Local Institution - 0269
Tampa, Florida, United States
Local Institution - 0276
Duluth, Georgia, United States
Local Institution - 0369
Marietta, Georgia, United States
Local Institution - 0433
Chicago, Illinois, United States
Local Institution - 0335
Iowa City, Iowa, United States
Local Institution - 0262
Baltimore, Maryland, United States
Local Institution - 0580
Silver Spring, Maryland, United States
Local Institution - 0471
Boston, Massachusetts, United States
Local Institution - 0430
Ann Arbor, Michigan, United States
Local Institution - 0254
Grand Rapids, Michigan, United States
Local Institution - 0572
Maple Grove, Minnesota, United States
Local Institution - 0318
Kansas City, Missouri, United States
Local Institution - 0336
St Louis, Missouri, United States
Local Institution - 0334
Omaha, Nebraska, United States
Local Institution - 0302
Buffalo, New York, United States
Local Institution - 0429
Lake Success, New York, United States
Local Institution - 0270
Mineola, New York, United States
Local Institution - 0526
Fargo, North Dakota, United States
Local Institution - 0339
Columbus, Ohio, United States
Local Institution - 0308
Portland, Oregon, United States
Local Institution - 0348
Allentown, Pennsylvania, United States
Local Institution - 0294
Pittsburgh, Pennsylvania, United States
Local Institution - 0312
Sioux Falls, South Dakota, United States
Local Institution - 0333
Nashville, Tennessee, United States
Sarah Cannon Institute
Nashville, Tennessee, United States
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
Arlington, Texas, United States
Texas Oncology, PA
Austin, Texas, United States
Local Institution - 0252
Houston, Texas, United States
Local Institution - 0576
Longview, Texas, United States
Local Institution - 0426
Salt Lake City, Utah, United States
Local Institution - 0278
Fairfax, Virginia, United States
Local Institution - 0577
Norfolk, Virginia, United States
Local Institution - 0491
Edmonds, Washington, United States
Local Institution - 0253
Seattle, Washington, United States
Local Institution - 0578
Vancouver, Washington, United States
Local Institution - 0071
ABB, Buenos Aires F.D., Argentina
Local Institution - 0174
Buenos Aires, , Argentina
Local Institution - 0073
Buenos Aires, , Argentina
Local Institution - 0069
Buenos Aires, , Argentina
Local Institution - 0172
Buenos Aires, , Argentina
Local Institution - 0277
Liverpool, New South Wales, Australia
Local Institution - 0157
St Leonards, New South Wales, Australia
Local Institution - 0274
Birtinya, Queensland, Australia
Local Institution - 0215
Herston, Queensland, Australia
Local Institution - 0191
Woolloongabba, Queensland, Australia
Local Institution - 0156
Adelaide, South Australia, Australia
Local Institution - 0155
Elizabeth Vale, South Australia, Australia
Local Institution - 0196
Ballarat, Victoria, Australia
Local Institution - 0190
Epping, Victoria, Australia
Local Institution - 0194
Shepparton, Victoria, Australia
Local Institution - 0519
St Albans, Victoria, Australia
Local Institution - 0154
Perth, Western Australia, Australia
Local Institution - 0160
Malvern, , Australia
Local Institution - 0159
Wentworthville, , Australia
Local Institution - 0078
Linz, , Austria
Local Institution - 0178
Salzburg, , Austria
Local Institution - 0082
Vienna, , Austria
Local Institution - 0103
Edegem, Antwerpen, Belgium
Local Institution - 0179
Brussels, MO, Belgium
Local Institution - 0122
Roeselare, West-Vlaanderen, Belgium
Local Institution - 0118
Brussels, , Belgium
Local Institution - 0115
Leuven, , Belgium
Local Institution - 0267
Curitiba, Paraná, Brazil
Local Institution - 0331
Natal/RN, Rio Grande do Norte, Brazil
Local Institution - 0342
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0373
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Local Institution - 0266
Barretos, São Paulo, Brazil
Local Institution - 0268
São Paulo, , Brazil
Local Institution - 0341
São Paulo, , Brazil
Local Institution - 0550
Calgary, Alberta, Canada
Local Institution - 0260
Halifax, Nova Scotia, Canada
Local Institution - 0255
Ottawa, Ontario, Canada
Local Institution - 0421
Toronto, Ontario, Canada
Local Institution - 0258
Montreal, Quebec, Canada
Local Institution - 0423
Montreal, Quebec, Canada
Local Institution - 0463
Santiago, Santiago Metropolitan, Chile
Local Institution - 0171
Santiago, Santiago Metropolitan, Chile
Local Institution - 0175
Santiago, Santiago Metropolitan, Chile
Local Institution - 0354
Fuzhou, Fujian, China
Local Institution - 0388
Fuzhou Fujian, Fujian, China
Local Institution - 0130
Guangzhou, Guangdong, China
Local Institution - 0353
Harbin, Heilongjiang, China
Local Institution - 0411
Changsha, Hunan, China
Local Institution - 0355
Shenyang, Liaoning, China
Local Institution - 0378
Shanghai, Shanghai Municipality, China
Local Institution - 0360
Hangzhou, Zhejiang, China
Local Institution - 0457
Hangzhou, , China
Local Institution - 0356
Shanghai, , China
Local Institution - 0248
Prague, Praha 5, Czechia
Local Institution - 0461
Prague, Praha, Hlavní Mesto, Czechia
Local Institution - 0180
Brno, , Czechia
Local Institution - 0188
Hradec Králové, , Czechia
Local Institution - 0182
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0121
Marseille, Provence-Alpes-Côte d'Azur Region, France
Local Institution - 0138
Dijon, , France
Local Institution - 0183
Paris, , France
Local Institution - 0181
Pessac, , France
Local Institution - 0127
Rouen, , France
Local Institution - 0097
Toulose, , France
Local Institution - 0098
Villejuif, , France
Local Institution - 0033
Dresden, Saxony, Germany
Local Institution - 0035
Berlin, , Germany
Local Institution - 0061
Bochum, , Germany
Local Institution - 0057
Düsseldorf, , Germany
Local Institution - 0040
Frankfurt, , Germany
Local Institution - 0058
Göttingen, , Germany
Local Institution - 0039
Hamburg, , Germany
Local Institution - 0041
Leipzig, , Germany
Local Institution - 0060
Mainz, , Germany
Local Institution - 0059
Mannheim, , Germany
Local Institution - 0034
München, , Germany
Local Institution - 0037
Ulm, , Germany
Local Institution - 0010
Nashik, Dādra and Nagar Haveli and Damān and Diu, India
Local Institution - 0036
Mumbai, Maharashtra, India
Local Institution - 0552
Mumbai, Maharashtra, India
Local Institution - 0006
Delhi, , India
Local Institution - 0554
Delhi, , India
Local Institution - 0557
Puducherry, , India
Local Institution - 0038
Pune, , India
Local Institution - 0584
San Giovanni Rotondo, Foggia, Italy
Local Institution - 0231
Milan, Milano, Italy
Local Institution - 0227
Catania, , Italy
Local Institution - 0111
Milan, , Italy
Local Institution - 0236
Napoli, , Italy
Local Institution - 0221
Padua, , Italy
Local Institution - 0226
Pisa, , Italy
Local Institution - 0233
Reggio Emilia, , Italy
Local Institution - 0053
Chiba, Chiba, Japan
Local Institution - 0045
Matsuyama, Ehime, Japan
Local Institution - 0051
Sapporo, Hokkaido, Japan
Local Institution - 0047
Kobe, Hyōgo, Japan
Local Institution - 0056
Yokohama, Kanagawa, Japan
Local Institution - 0066
Suita, Osaka, Japan
Local Institution - 0521
Takatsuki, Osaka, Japan
Local Institution - 0046
Hidaka, Saitama, Japan
Local Institution - 0475
Chuo-ku, Tokyo, Japan
Local Institution - 0044
Koto-ku, Tokyo, Japan
Local Institution - 0473
Chikusa-ku, , Japan
Local Institution - 0052
Fukuoka, , Japan
Local Institution - 0493
Kashiwa, , Japan
Local Institution - 0506
Osaka, , Japan
Local Institution - 0067
Sendai, , Japan
Local Institution - 0054
Sunto-gun, , Japan
Local Institution - 0112
Amsterdam, North Holland, Netherlands
Local Institution - 0170
Groningen, , Netherlands
Local Institution - 0216
Tilburg, , Netherlands
Local Institution - 0167
Utrecht, , Netherlands
Local Institution - 0364
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0452
Jelenia Góra, Lower Silesian Voivodeship, Poland
Local Institution - 0363
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0525
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0359
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0451
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0362
Opole, , Poland
Local Institution - 0282
Cluj-Napoca, Cluj, Romania
Local Institution - 0100
Bucharest, , Romania
Local Institution - 0142
Cluj-Napoca, , Romania
Local Institution - 0189
Craiova, , Romania
Local Institution - 0370
Iași, , Romania
Local Institution - 0143
Iași, , Romania
Local Institution - 0145
Singapore, Central Singapore, Singapore
Local Institution - 0147
Singapore, , Singapore
Local Institution - 0285
Singapore, , Singapore
Local Institution - 0511
Singapore, , Singapore
Local Institution - 0406
Seongnam, Gyeonggido, South Korea
Local Institution - 0404
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0394
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0395
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0492
Seoul, , South Korea
Local Institution - 0405
Seoul, , South Korea
Local Institution - 0163
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0240
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0229
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0225
Pamplona, Navarre, Spain
Local Institution - 0228
Madrid, , Spain
Local Institution - 0232
Málaga, , Spain
Local Institution - 0234
Seville, , Spain
Local Institution - 0074
Stockholm, Stockholm County, Sweden
Local Institution - 0185
Gothenburg, Västra Götaland County, Sweden
Local Institution - 0400
Lund, , Sweden
Local Institution - 0301
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Local Institution - 0289
Kaohsiung City, , Taiwan
Local Institution - 0291
Tainan, Taiana, , Taiwan
Local Institution - 0297
Taipei, , Taiwan
Local Institution - 0300
Taipei, , Taiwan
Local Institution - 0449
Taoyuan District, , Taiwan
Local Institution - 0020
Adana, , Turkey (Türkiye)
Local Institution - 0065
Ankara, , Turkey (Türkiye)
Local Institution - 0018
Erzurum, , Turkey (Türkiye)
Local Institution - 0296
Istanbul, , Turkey (Türkiye)
Local Institution - 0295
Kadiköy/Istanbul, , Turkey (Türkiye)
Local Institution - 0305
Manchester, Lancashire, United Kingdom
Local Institution - 0307
Glasgow, , United Kingdom
Local Institution - 0368
Kent, , United Kingdom
Local Institution - 0596
London, , United Kingdom
Local Institution - 0316
Sutton, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site 0263
Role: primary
Site 0345
Role: primary
Site 0317
Role: primary
Site 0330
Role: primary
Site 0293
Role: primary
Site 0574
Role: primary
Site 0575
Role: primary
Site 0269
Role: primary
Site 0276
Role: primary
Site 0369
Role: primary
Site 0433
Role: primary
Site 0335
Role: primary
Site 0262
Role: primary
Site 0580
Role: primary
Site 0471
Role: primary
Site 0430
Role: primary
Site 0254
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Site 0572
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Site 0318
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Site 0336
Role: primary
Site 0334
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Site 0302
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Site 0429
Role: primary
Site 0270
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Site 0526
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Site 0339
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Site 0308
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Site 0348
Role: primary
Site 0294
Role: primary
Site 0312
Role: primary
Site 0333
Role: primary
Meredith Pelster, Site 0570
Role: primary
Laith Abushahin, Site 0573
Role: primary
Vivian Cline, Site 0571
Role: primary
Site 0252
Role: primary
Site 0576
Role: primary
Site 0426
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Site 0278
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Site 0577
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Site 0491
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Site 0253
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Site 0578
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Site 0071
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Site 0174
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Site 0073
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Site 0069
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Site 0172
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Site 0277
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Site 0157
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Site 0274
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Site 0215
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Site 0191
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Site 0156
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Site 0155
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Site 0196
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Site 0190
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Site 0194
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Site 0519
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Site 0154
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Site 0160
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Site 0159
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Site 0078
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Site 0178
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Site 0082
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Site 0103
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Site 0179
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Site 0122
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Site 0118
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Site 0115
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Site 0267
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Site 0331
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Site 0342
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Site 0373
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Site 0266
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Site 0268
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Site 0341
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Site 0550
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Site 0260
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Site 0255
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Site 0421
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Site 0258
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Site 0423
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Site 0463
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Site 0171
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Site 0175
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Site 0354
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Site 0388
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Site 0130
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Site 0353
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Site 0411
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Site 0355
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Site 0378
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Site 0360
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Site 0457
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Site 0356
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Site 0248
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Site 0461
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Site 0180
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Site 0188
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Site 0182
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Site 0121
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Site 0138
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Site 0183
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Site 0181
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Site 0127
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Site 0097
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Site 0098
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Site 0033
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Site 0035
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Site 0061
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Site 0057
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Site 0040
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Site 0058
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Site 0039
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Site 0041
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Site 0060
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Site 0059
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Site 0034
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Site 0037
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Site 0010
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Site 0036
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Site 0552
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Site 0006
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Site 0554
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Site 0557
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Site 0038
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Site 0584
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Site 0231
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Site 0227
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Site 0111
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Site 0236
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Site 0221
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Site 0226
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Site 0233
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Site 0053
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Site 0045
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Site 0051
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Site 0047
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Site 0056
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Site 0066
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Site 0521
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Site 0046
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Site 0475
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Site 0044
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Site 0473
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Site 0052
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Site 0493
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Site 0506
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Site 0067
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Site 0054
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Site 0112
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Site 0170
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Site 0216
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Site 0167
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Site 0364
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Site 0452
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Site 0363
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Site 0525
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Site 0359
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Site 0451
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Site 0362
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Site 0282
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Site 0100
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Site 0142
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Site 0189
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Site 0370
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Site 0143
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Site 0145
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Site 0147
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Site 0285
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Site 0511
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Site 0406
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Site 0394
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Site 0395
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Site 0492
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Site 0405
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Site 0163
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Site 0240
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Site 0229
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Site 0225
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Site 0228
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Site 0232
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Site 0234
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Site 0074
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Site 0185
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Site 0400
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Site 0301
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Site 0289
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Site 0291
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Site 0297
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Site 0300
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Site 0449
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Site 0020
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Site 0065
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Site 0018
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Site 0296
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Site 0295
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Site 0305
Role: primary
Site 0307
Role: primary
Site 0368
Role: primary
Site 0596
Role: primary
Site 0316
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-523224-45
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1325-6505
Identifier Type: OTHER
Identifier Source: secondary_id
CA266-0003
Identifier Type: -
Identifier Source: org_study_id
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