Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
NCT ID: NCT07106762
Last Updated: 2025-11-06
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
470 participants
INTERVENTIONAL
2025-09-30
2033-11-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Iza-bren
Specified dose on specified days
Arm B
Iza-bren
Specified dose on specified days
Arm C
Cisplatin
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Carboplatin
Specified dose on specified days
Arm D
Iza-bren
Specified dose on specified days
Arm E
Cisplatin
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Carboplatin
Specified dose on specified days
Interventions
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Cisplatin
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Carboplatin
Specified dose on specified days
Iza-bren
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be eligible to receive platinum-based chemotherapy.
* Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
* Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
* Participants must have ≥ 1 measurable lesion per RECIST v1.1.
* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion Criteria
* Participants must not have received \>2 prior regimens irrespective of the setting.
* Participants must not have prior ADC therapy targeting EGFR or HER3.
* Participants must not have prior therapy with topoisomerase 1 inhibitor.
* Participants must not have active, untreated brain metastases.
18 Years
ALL
No
Sponsors
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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 - 0167
Gilbert, Arizona, United States
Local Institution - 0162
Fullerton, California, United States
Local Institution - 0163
Sacramento, California, United States
Local Institution - 0139
Sacramento, California, United States
Local Institution - 0245
Dillon, Colorado, United States
Local Institution - 0191
Edwards, Colorado, United States
Local Institution - 0250
Washington D.C., District of Columbia, United States
Local Institution - 0247
Miami, Florida, United States
Local Institution - 0193
Lexington, Kentucky, United States
Local Institution - 0232
Baltimore, Maryland, United States
Local Institution - 0195
Boston, Massachusetts, United States
Local Institution - 0168
Detroit, Michigan, United States
Local Institution - 0192
Cleveland, Ohio, United States
Local Institution - 0161
Columbus, Ohio, United States
Local Institution - 0141
Portland, Oregon, United States
Local Institution - 0186
Nashville, Tennessee, United States
Local Institution - 0084
Nashville, Tennessee, United States
Local Institution - 0249
Abilene, Texas, United States
Local Institution - 0187
Austin, Texas, United States
Local Institution - 0111
Murray, Utah, United States
Local Institution - 0158
Charlottesville, Virginia, United States
Local Institution - 0188
Norfolk, Virginia, United States
Local Institution - 0200
Seattle, Washington, United States
Local Institution - 0028
CABA, Buenos Aires, Argentina
Local Institution - 0023
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0024
ABB, Buenos Aires F.D., Argentina
Local Institution - 0026
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0025
Córdoba, , Argentina
Local Institution - 0027
Mendoza, , Argentina
Macquarie University
Macquarie University, New South Wales, Australia
Local Institution - 0151
St Leonards, New South Wales, Australia
Local Institution - 0150
Heidelberg, Victoria, Australia
Local Institution - 0155
Innsbruck, Tyrol, Austria
Local Institution - 0109
Vienna, Vienna, Austria
Local Institution - 0131
Vienna, Vienna, Austria
Local Institution - 0013
Wilrijk, Antwerpen, Belgium
Local Institution - 0011
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0014
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0012
Liège, , Belgium
Local Institution - 0129
Salvador, Estado de Bahia, Brazil
Local Institution - 0121
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0130
Rio de Janeiro, , Brazil
Local Institution - 0124
São Paulo, , Brazil
Local Institution - 0020
Edmonton, Alberta, Canada
Local Institution - 0021
Ottawa, Ontario, Canada
Local Institution - 0016
Toronto, Ontario, Canada
Local Institution - 0017
Montreal, Quebec, Canada
Local Institution - 0050
Beijing, Beijing Municipality, China
Local Institution - 0224
Beijing, Beijing Municipality, China
Local Institution - 0048
Fuzhou, Fujian, China
Local Institution - 0060
Fuzhou, Fujian, China
Local Institution - 0056
Xiamen, Fujian, China
Local Institution - 0051
Guangzhou, Guangdong, China
Local Institution - 0058
Guangzhou, Guangdong, China
Local Institution - 0226
Guangzhou, Guangdong, China
Local Institution - 0201
Wuhan, Hubei, China
Local Institution - 0059
Changsha, Hunan, China
Local Institution - 0044
Nanjing, Jiangsu, China
Local Institution - 0046
Nanjing, Jiangsu, China
Local Institution - 0114
Nantong, Jiangsu, China
Local Institution - 0206
Nanchang, Jiangxi, China
Local Institution - 0184
Jinan, Shandong, China
Local Institution - 0156
Qingdao, Shandong, China
Local Institution - 0205
Yantai, Shandong, China
Local Institution - 0042
Shanghai, Shanghai Municipality, China
Local Institution - 0225
Chengdu, Sichuan, China
Local Institution - 0052
Tianjin, Tianjin Municipality, China
Local Institution - 0227
Tianjin, Tianjin Municipality, China
Local Institution - 0157
Hangzhou, Zhejiang, China
Local Institution - 0053
Wenzhou, Zhejiang, China
Local Institution - 0064
Zhengzhou, , China
Local Institution - 0146
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0041
Prague, Praha 5, Czechia
Local Institution - 0009
Nice, Alpes-Maritimes, France
Local Institution - 0040
Strasbourg, Alsace, France
Local Institution - 0004
Bordeaux, Aquitaine, France
Local Institution - 0006
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Local Institution - 0223
Suresnes, Hauts-de-Seine, France
Local Institution - 0002
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0005
Marseille, Provence-Alpes-Côte d'Azur Region, France
Local Institution - 0003
Clermont-Ferrand, Puy-de-Dôme, France
Local Institution - 0001
Villejuif, Val-de-Marne, France
Local Institution - 0008
Paris, , France
Local Institution - 0007
Paris, Île-de-France Region, France
Local Institution - 0133
Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0080
Nürtingen, Baden-Wurttemberg, Germany
Local Institution - 0079
Munich, Bavaria, Germany
Local Institution - 0135
Regensburg, Bavaria, Germany
Local Institution - 0144
Hanover, Lower Saxony, Germany
Local Institution - 0075
Kiel, Schleswig-Holstein, Germany
Local Institution - 0147
Jena, Thuringia, Germany
Local Institution - 0154
Berlin, , Germany
Local Institution - 0076
Düsseldorf, , Germany
Local Institution - 0190
Frankfurt, , Germany
Local Institution - 0134
Hamburg, , Germany
Local Institution - 0078
Herne, , Germany
Local Institution - 0132
Ulm, , Germany
Local Institution - 0238
Cork, , Ireland
Local Institution - 0236
Dublin, , Ireland
Local Institution - 0096
Petah Tikva, Central District, Israel
Local Institution - 0106
Ẕerifin, Central District, Israel
Local Institution - 0095
Jerusalem, Jerusalem, Israel
Local Institution - 0094
Haifa, Northern District, Israel
Local Institution - 0097
Bari, Apulia, Italy
Local Institution - 0107
Naples, Campania, Italy
Local Institution - 0099
Genoa, Liguria, Italy
Local Institution - 0102
Rome, Roma, Italy
Local Institution - 0100
Pisa, Tuscany, Italy
Local Institution - 0103
Padua, Veneto, Italy
Local Institution - 0104
Milan, , Italy
Local Institution - 0105
Milan, , Italy
Local Institution - 0098
Parma, , Italy
Local Institution - 0183
Kawasaki, Kanagawa, Japan
Local Institution - 0171
Bunkyo-ku, Tokyo, Japan
Local Institution - 0169
Koto-ku, Tokyo, Japan
Local Institution - 0179
Toyoma, Toyama, Japan
Local Institution - 0036
Breda, North Brabant, Netherlands
Local Institution - 0033
Amsterdam, North Holland, Netherlands
Local Institution - 0031
Leeuwarden, Provincie Friesland, Netherlands
Local Institution - 0239
Lørenskog, Akershus, Norway
Local Institution - 0242
Tønsberg, Vestfold, Norway
Local Institution - 0246
Sarpsborg, Østfold fylke, Norway
Local Institution - 0067
Craiova, Dolj, Romania
Local Institution - 0066
Cluj-Napoca, , Romania
Local Institution - 0072
Iași, , Romania
Local Institution - 0199
Valencia, Valenciana, Comunitat, Spain
Local Institution - 0216
Badajoz, , Spain
Local Institution - 0234
Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0241
Lund, , Sweden
Local Institution - 0235
Stockholm, , Sweden
Local Institution - 0077
Sankt Gallen, Canton of St. Gallen, Switzerland
Local Institution - 0117
Bellinzona, Canton Ticino, Switzerland
Local Institution - 0108
Chur, , Switzerland
Local Institution - 0148
Zurich, , Switzerland
Local Institution - 0243
Glasgow, Glasgow City, United Kingdom
Local Institution - 0237
London, , United Kingdom
Local Institution - 0230
Sheffield, , United Kingdom
Local Institution - 0231
Sutton, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0167
Role: primary
Site 0162
Role: primary
Site 0163
Role: primary
Site 0139
Role: primary
Site 0191
Role: primary
Site 0250
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Site 0247
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Site 0193
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Site 0232
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Site 0195
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Site 0168
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Site 0192
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Site 0161
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Site 0141
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Site 0186
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Site 0084
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Site 0249
Role: primary
Site 0187
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Site 0111
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Site 0158
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Site 0188
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Site 0200
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Site 0028
Role: primary
Site 0023
Role: primary
Site 0024
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Site 0026
Role: primary
Site 0025
Role: primary
Site 0027
Role: primary
Alison Zhang, Site 0149
Role: primary
Site 0151
Role: primary
Site 0150
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Site 0155
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Site 0109
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Site 0131
Role: primary
Site 0013
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Site 0011
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Site 0014
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Site 0012
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Site 0129
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Site 0121
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Site 0130
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Site 0124
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Site 0020
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Site 0021
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Site 0016
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Site 0017
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Site 0050
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Site 0224
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Site 0048
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Site 0060
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Site 0056
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Site 0051
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Site 0058
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Site 0226
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Site 0201
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Site 0059
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Site 0044
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Site 0046
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Site 0114
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Site 0206
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Site 0184
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Site 0156
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Site 0205
Role: primary
Site 0042
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Site 0225
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Site 0052
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Site 0227
Role: primary
Site 0157
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Site 0053
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Site 0064
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Site 0146
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Site 0041
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Site 0009
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Site 0040
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Site 0004
Role: primary
Site 0006
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Site 0223
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Site 0002
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Site 0005
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Site 0003
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Site 0001
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Site 0008
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Site 0007
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Site 0133
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Site 0080
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Site 0079
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Site 0135
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Site 0144
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Site 0075
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Site 0147
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Site 0154
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Site 0076
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Site 0190
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Site 0134
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Site 0078
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Site 0132
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Site 0238
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Site 0236
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Site 0096
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Site 0106
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Site 0095
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Site 0094
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Site 0097
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Site 0107
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Site 0099
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Site 0102
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Site 0100
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Site 0103
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Site 0104
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Site 0105
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Site 0098
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Site 0183
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Site 0171
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Site 0169
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Site 0179
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Site 0036
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Site 0033
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Site 0031
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Site 0239
Role: primary
Site 0242
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Site 0246
Role: primary
Site 0067
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Site 0066
Role: primary
Site 0072
Role: primary
Site 0199
Role: primary
Site 0216
Role: primary
Site 0234
Role: primary
Site 0241
Role: primary
Site 0235
Role: primary
Site 0077
Role: primary
Site 0117
Role: primary
Site 0108
Role: primary
Site 0148
Role: primary
Site 0243
Role: primary
Site 0237
Role: primary
Site 0230
Role: primary
Site 0231
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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EU CTR
Identifier Type: OTHER
Identifier Source: secondary_id
WHO
Identifier Type: OTHER
Identifier Source: secondary_id
CA244-0012
Identifier Type: -
Identifier Source: org_study_id