Actively Recruiting
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Led by Bristol-Myers Squibb · Updated on 2026-05-12
470
Participants Needed
162
Research Sites
424 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
CONDITIONS
Official Title
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed advanced urothelial carcinoma.
- 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 2 1 measurable lesion per RECIST v1.1.
- Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
You will not qualify if you...
- Participants must not have platinum-based chemotherapy exposure within 12 months.
- 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.
- Other protocol-defined inclusion/exclusion criteria apply.
AI-Screening
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Trial Site Locations
Total: 162 locations
1
Local Institution - 0167
Gilbert, Arizona, United States, 85234
Not Yet Recruiting
2
Local Institution - 0162
Fullerton, California, United States, 92835
Not Yet Recruiting
3
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94304
Actively Recruiting
4
Sutter Health - Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Actively Recruiting
5
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
6
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
Actively Recruiting
7
Sutter Santa Rosa
Santa Rosa, California, United States, 95403
Actively Recruiting
8
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
Actively Recruiting
9
Local Institution - 0245
Dillon, Colorado, United States, 80435
Withdrawn
10
Shaw Cancer Center
Edwards, Colorado, United States, 81632
Actively Recruiting
11
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
12
Local Institution - 0247
Miami, Florida, United States, 33176
Not Yet Recruiting
13
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
14
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
15
Local Institution - 0195
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
16
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
17
Local Institution - 0248
Buffalo, New York, United States, 14203
Not Yet Recruiting
18
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
19
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
20
Fairview Hospital
Cleveland, Ohio, United States, 44111
Actively Recruiting
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
The James Outpatient Care West Campus
Columbus, Ohio, United States, 43221
Actively Recruiting
23
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
24
Local Institution - 0141
Portland, Oregon, United States, 97239
Not Yet Recruiting
25
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
Local Institution - 0084
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
27
Texas Oncology - West Texas
Abilene, Texas, United States, 79606
Actively Recruiting
28
Local Institution - 0187
Austin, Texas, United States, 78705
Not Yet Recruiting
29
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
30
Local Institution - 0253
St. George, Utah, United States, 84790
Not Yet Recruiting
31
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
32
Local Institution - 0188
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
33
Local Institution - 0200
Seattle, Washington, United States, 98101
Not Yet Recruiting
34
Local Institution - 0255
Seattle, Washington, United States, 98109
Not Yet Recruiting
35
Hospital Británico de Buenos Aires
CABA, Buenos Aires, Argentina, CP1280AEB
Actively Recruiting
36
Asociación de Beneficencia Hospital Sirio Libanés
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1419
Actively Recruiting
37
Local Institution - 0023
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Not Yet Recruiting
38
Local Institution - 0024
ABB, Buenos Aires F.D., Argentina, C1199ABB
Not Yet Recruiting
39
Local Institution - 0025
Córdoba, Argentina, 5000
Not Yet Recruiting
40
Fundacion Centro Oncologico de Integración Regional
Mendoza, Argentina, M5500AYB
Actively Recruiting
41
Macquarie University
Macquarie University, New South Wales, Australia, 2109
Actively Recruiting
42
GenesisCare North Shore
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
43
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
44
Medizinische Universität Wien
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
45
Klinik Ottakring
Vienna, State of Vienna, Austria, 1160
Actively Recruiting
46
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
47
ZAS Augustinus
Wilrijk, Antwerpen, Belgium, 2610
Actively Recruiting
48
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
49
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
50
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
51
Local Institution - 0129
Salvador, Estado de Bahia, Brazil, 41253-190
Not Yet Recruiting
52
Local Institution - 0121
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Not Yet Recruiting
53
Local Institution - 0130
Rio de Janeiro, Brazil, 22451-100
Not Yet Recruiting
54
Local Institution - 0124
São Paulo, Brazil, 01452-000
Not Yet Recruiting
55
Local Institution - 0020
Edmonton, Alberta, Canada, T6G 1Z2
Not Yet Recruiting
56
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
57
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
58
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
59
Local Institution - 0050
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
60
Local Institution - 0224
Beijing, Beijing Municipality, China, 100091
Not Yet Recruiting
61
Local Institution - 0048
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
62
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
63
Local Institution - 0056
Xiamen, Fujian, China, 361003
Not Yet Recruiting
64
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
65
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
66
Zhujiang Hospital
Guangzhou, Guangdong, China, 510280
Actively Recruiting
67
Local Institution - 0064
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
68
Local Institution - 0201
Wuhan, Hubei, China, 430030
Not Yet Recruiting
69
Local Institution - 0059
Changsha, Hunan, China, 410013
Not Yet Recruiting
70
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
Actively Recruiting
71
Local Institution - 0046
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
72
Local Institution - 0114
Nantong, Jiangsu, China, 226361
Not Yet Recruiting
73
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
74
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
75
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Actively Recruiting
76
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Actively Recruiting
77
Local Institution - 0042
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
78
Sichuan Cancer hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
79
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610066
Actively Recruiting
80
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
81
Local Institution - 0227
Tianjin, Tianjin Municipality, China, 300070
Not Yet Recruiting
82
Local Institution - 0157
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
83
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
84
Local Institution - 0115
Brno, Brno-město, Czechia, 656 53
Not Yet Recruiting
85
Local Institution - 0146
Hradec Králové, Hradec Králové, Czechia, 500 05
Not Yet Recruiting
86
Local Institution - 0041
Prague, Praha 5, Czechia, 150 06
Not Yet Recruiting
87
Centre Antoine-Lacassagne
Nice, Alpes-Maritimes, France, 06189
Actively Recruiting
88
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, France, 67098
Actively Recruiting
89
CHU de Bordeaux Hop St ANDRE
Bordeaux, Aquitaine, France, 33075
Actively Recruiting
90
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
Actively Recruiting
91
CHRU de Brest
Brest, Finistère, France, 29200
Actively Recruiting
92
Hôpital Foch
Suresnes, Hauts-de-Seine, France, 92151
Actively Recruiting
93
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, France, 44805
Actively Recruiting
94
Local Institution - 0005
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13273
Withdrawn
95
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, France, 63011
Actively Recruiting
96
Gustave Roussy
Villejuif, Val-de-Marne, France, 94800
Actively Recruiting
97
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
98
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, France, 75014
Actively Recruiting
99
NCT
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
100
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany, 72622
Actively Recruiting
101
TUM Klinikum
Munich, Bavaria, Germany, 81675
Actively Recruiting
102
Klinikum Nürnberg Nord
Nuremberg, Bavaria, Germany, 90419
Actively Recruiting
103
Caritas-Krankenhaus St. Josef
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
104
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
105
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
106
Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747
Actively Recruiting
107
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany, 10117
Actively Recruiting
108
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
109
Krankenhaus Nordwest GmbH
Frankfurt, Germany, 60488
Actively Recruiting
110
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
111
Marienhospital Herne
Herne, Germany, 44625
Actively Recruiting
112
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
113
Local Institution - 0238
Cork, Ireland, T12 DC4A
Not Yet Recruiting
114
Tallaght University Hospital
Dublin, Ireland, D24 NR0A
Actively Recruiting
115
Rabin Medical Center
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
116
Local Institution - 0106
Ẕerifin, Central District, Israel, 70300
Not Yet Recruiting
117
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
118
Rambam Health Care Campus
Haifa, Northern District, Israel, 3109601
Actively Recruiting
119
A.O.U.C. Policlinico di Bari
Bari, Apulia, Italy, 70124
Actively Recruiting
120
Ospedale San Martino
Genoa, Liguria, Italy, 16132
Actively Recruiting
121
Istituto Nazionale Tumori Regina Elena
Rome, Roma, Italy, 00144
Actively Recruiting
122
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56126
Actively Recruiting
123
Istituto Oncologico Veneto IRCCS
Castelfranco Veneto, Veneto, Italy, 31033
Actively Recruiting
124
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
125
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
126
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
127
Azienda Ospedaliero Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
128
Local Institution - 0183
Kawasaki, Kanagawa, Japan, 216-8511
Not Yet Recruiting
129
Local Institution - 0171
Bunkyo-ku, Tokyo, Japan, 1138603
Not Yet Recruiting
130
Local Institution - 0169
Koto-ku, Tokyo, Japan, 135-8550
Not Yet Recruiting
131
Local Institution - 0179
Toyoma, Toyama, Japan, 930-0194
Not Yet Recruiting
132
Local Institution - 0036
Breda, North Brabant, Netherlands, 4818 CK
Not Yet Recruiting
133
Local Institution - 0033
Amsterdam, North Holland, Netherlands, 1066 CX
Not Yet Recruiting
134
Local Institution - 0031
Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
Not Yet Recruiting
135
Akershus Universitetssykehus
Lørenskog, Akershus, Norway, 1478
Actively Recruiting
136
Sykehuset i Vestfold
Tønsberg, Vestfold, Norway, 3103
Actively Recruiting
137
Sykehuset Østfold Kalnes
Sarpsborg, Østfold fylke, Norway, 1714
Actively Recruiting
138
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania, 200542
Actively Recruiting
139
Institutul Oncologic Cluj
Cluj-Napoca, Romania, 400015
Actively Recruiting
140
Institutul Regional de Oncologie
Iași, Romania, 700483
Actively Recruiting
141
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
142
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
143
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
144
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
145
Local Institution - 0199
Valencia, Valenciana, Comunitat, Spain, 46009
Not Yet Recruiting
146
Hospital Infanta Cristina
Badajoz, Spain, 06006
Actively Recruiting
147
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
148
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
149
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
150
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
151
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
152
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01], Sweden, 171 64
Actively Recruiting
153
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
Actively Recruiting
154
Local Institution - 0241
Malmö, Sweden, 205 02
Not Yet Recruiting
155
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
156
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
157
Kantonsspital Graubünden
Chur, Switzerland, 7000
Actively Recruiting
158
UniversitätsSpital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
159
Local Institution - 0243
Glasgow, Glasgow City, United Kingdom, G12 0YN
Not Yet Recruiting
160
St Bartholomew's Hospital
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
161
Royal Marsden Hospital (Sutton)
London, Sutton, United Kingdom, SM2 5PT
Actively Recruiting
162
Local Institution - 0230
Sheffield, United Kingdom, S10 2SJ
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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