Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

April 17, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease.

Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced).

In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Urothelial Carcinoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Berazategui, Argentina, B1884BBF
    - Centro de Oncologia e Investigacion de Buenos Aires (COIBA)
  - Buenos Aire, Argentina, C1019ABS
    - Centro Medico Austral
  - Buenos Aires, Argentina, C1426ANZ
    - Instituto Medico Especializado Alexander Fleming
  - Buenos Aires, Argentina
    - Centro Oncologico Korben
  - CABA, Argentina, 1425
    - Investigaciones Clinicas Moleculares (ICM)
  - CABA, Argentina, C1430EFA
    - Labmedicina
  - Córdoba, Argentina, X5008AAC
    - CEMAIC - Centro Medico Privado
  - Rosario, Argentina, 2000
    - Comité Provincial de Bioética-Rosario
  - Rosario, Argentina, 2000
    - Grupo de Investigación en Oncología Clínica del Santario Parque
  - Salta, Argentina, 4400
    - Consultorio Dr. Miguel Ángel Escudero
  - Salta, Argentina, 4400
    - Oncologia Salta
- Buenos Aires
  - Pergamino, Buenos Aires, Argentina, 2700
    - Centro de Investigación Pergamino SA
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, 1113
    - Centro de Investigaciones Medicas y Desarrollo LC
- Río Negro Province
  - Viedma, Río Negro Province, Argentina, R8500ACE
    - Clínica Viedma
  - Viedma, Río Negro Province, Argentina, 8500
    - Fundación Dr. Ruben Kowalyszyn
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000DSV
    - Sanatorio Parque
Australia
- - Caringbah, Australia, 2229
    - South Eastern Sydney Local Health District
  - Elizabeth Vale, Australia, 5112
    - Lyell McEwin Hospital
  - Frankston, Australia, 3199
    - Peninsula and South East Oncology
  - NSW, Australia, NSW 2450
    - Mid North Coast Local Health District
  - Port Macquarie, Australia, 2444
    - Port Macquarie Base Hospital
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - Concord Cancer Centre Concord Repatriation General Hospital
  - Darlinghurst, New South Wales, Australia, 2010
    - St Vincent's Clinic
  - Darlinghurst, New South Wales, Australia, 2010
    - Saint Vincents Hospital Sydney - Human Research Ethics Committee
  - Macquarie University, New South Wales, Australia, 2109
    - Macquarie University Hospital
  - North Ryde, New South Wales, Australia, 2109
    - Macquarie University
  - Randwick, New South Wales, Australia, 2031
    - Prince of Wales Hospital
- Queensland
  - Brisbane, Queensland, Australia, 4101
    - Mater Misericordiae - Mater Hospital Brisbane
  - Chermside, Queensland, Australia, 4032
    - Icon Cancer Centre Chermside
  - Herston, Queensland, Australia, 4029
    - Icon Cancer Centre Chermside
  - South Bribane, Queensland, Australia, 4101
    - Mater Research
- Victoria
  - Frankston, Victoria, Australia, 3199
    - Peninsula & South Eastern Hematology and Oncology Group (PASO)
  - Malvern, Victoria, Australia, 3144
    - Cabrini Hospital
Belgium
- - Ghent, Belgium, 9000
    - University Hospital Ghent
  - Ghent, Belgium, 9000
    - Algemeen Ziekenhuis Maria Middelares
  - Ghent, Belgium, 9000
    - AZ St. Lucas
Brazil
- - Barretos, Brazil, 14784-400
    - Hospital de Cancer de Barretos - Fundacao Pio XII
  - CuriBba, Brazil, 81520-060
    - Erasto Gaertner Hospital
  - Rio de Janeiro, Brazil, 20230-130
    - Instituto Nacional de Cancer - INCa
  - Rio de Janeiro, Brazil, 20231-050
    - Instituto Nacional de Cancer - INCa
  - Salvador, Brazil, 41820021
    - Centro de Oncologia da Bahia
  - São Paulo, Brazil, 01327-001
    - Hospital Alemao Oswaldo Cruz
- Ceará
  - Fortaleza, Ceará, Brazil, 60810-180
    - Suporte Nutricional e Quimioterapia - PRONUTRIR
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30380472
    - Associacao Mario Penna - Hospital Luxemburgo - NEPI Nucleo de Ensino Pesquisa e Inovacao
- Rio Grande do Sul
  - Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
    - Hospital São Vicente de Paulo
  - Passo Fundo, Rio Grande do Sul, Brazil, 99010-090
    - Hospital São Vicente de Paulo
  - Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
    - Hospital Mae de Deus
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610000
    - Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
  - Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
    - Hospital Nossa Senhora da Conceicao / Grupo Hospitalar Conceicao
- São Paulo
  - Jaú, São Paulo, Brazil, 17210080
    - Fundação Doutor Amaral Carvalho
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Arthur J.E. Child Comprehensive Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - University of Alberta / Cross Cancer Institute
- Ontario
  - Oshawa, Ontario, Canada, L1G 2B9
    - Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)
  - Toronto, Ontario, Canada, M5G 2C4
    - University Health Network
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Cancer Centre - University Health Network
Chile
- Region Metropolitana Santiago
  - Los Condes, Region Metropolitana Santiago, Chile, 7560908
    - Centro de Oncología de Precisión
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 8420383
    - Centro de Investigacion Clinica Bradford Hill
Czechia
- - Olomouc, Czechia, 779 00
    - Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
- Hradec Králové
  - Hradec Králové, Hradec Králové, Czechia, 500 05
    - Fakultni nemocnice Hradec Kralove
France
- - Bordeaux, France, 33076
    - Institut Bergonié Centre de Lutte Contre le Cancer (CLCC)
  - Strasbourg, France, 67200
    - Institut de cancerologie Strasbourg Europe
  - Strasbourg, France, 67091
    - Unite de Coordination de la Biologie des Essais Cliniques
  - Villejuif, France, 94805
    - Institut Gustave Roussy
- Grand Est
  - Starsbourg, Grand Est, France, 67000
    - Centre Paul Strauss
- Rhône
  - Pierre-Bénite, Rhône, France, 69310
    - Hospices Civils de Lyon - Hopitale Lyon Sud
Greece
- - Cholargós, Greece, 15562
    - Metropolitan General Hospital Healthcare Facilities Operation and Management Single Member S.A.
- Attikí
  - Marousi, Attikí, Greece, 151 25
    - Athens Medical Center
Hungary
- - Budapest, Hungary, 1122
    - Országos Onkológiai Intézet
  - Kecskemét, Hungary, 6000
    - Bacs-Kiskun Varmegyei Oktatokorhaz
Ireland
- - Dublin, Ireland, D07 R2WY
    - Mater Misericordiae University Hospital
  - Dublin, Ireland, D09 AOEA
    - Beaumont Hospital
  - Tallaght, Ireland, D24 NR0A
    - Tallaght University Hospital
Israel
- - Beersheba, Israel, 8410101
    - Soroka Medical Center
  - Hafia, Israel, 3109601
    - Rambam Health Care Campus
  - Jerusalem, Israel, 9112001
    - Hadassah University Hospital at Ein Kerem
  - Kefar Sava, Israel, 4428164
    - Meir Medical Center
  - Petah Tikva, Israel, 4941492
    - Rabin Medical Center
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center
- Other
  - Jerusalem, Other, Israel, 9103102
    - Shaare Zedek Medical Center
  - Ramat Gan, Other, Israel, 52621
    - Sheba Medical Center.
Italy
- - Cremona, Italy, 26100
    - ASST Cremona Farmacia Ospedaliera
  - Florence, Italy, 50134
    - U.O. Farmacia Ospedaliera a Politiche del Farmaco Az. Osp. Universitaria Careggi
  - Genova, Italy, 16132
    - Ospedale Policlinico San Martino Farmacia
  - Pisa, Italy, 56126
    - Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
  - Pisa, Italy, 56126
    - Azienda Ospedaliera Universitaria Pisana, U.O. Farmacia Ospedaliera
  - Ravenna, Italy, 48121
    - Unita Operative di Oncologia,Ospedale S.Maria delle Croci
  - Terni, Italy, 05100
    - SC ONCOLOGYA Medica e Traslazionale Azienda Ospedaliera S.Maria di terni
  - Verona, Italy, 37134
    - Centro Ricerche Cliniche Di Verona Srl
  - Verona, Italy, 37124
    - Azienda Ospedaliera Universitaria Integrata di Verona
- Apulia
  - Tricase, Apulia, Italy, 73039
    - Azienda Ospedaliera Cardinale Giovanni Panico
- Liguria
  - Genoa, Liguria, Italy, 16132
    - Ospedale Policlinico San Martino
- Milan
  - Lombardy, Milan, Italy, 20132
    - IRCCS San Raffaele Hospital ,Genitourinary medical Oncology
- Milano
  - Rozzano, Milano, Italy, 20089
    - IRCCS Istituto Clinico Humanitas
- Naples
  - Giugliano in Campania, Naples, Italy, 80014
    - Azienda Sanitaria Locale Napoli 2 Nord
- Other
  - Bari, Other, Italy, 70124
    - Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
  - Pozzuoli (NA), Other, Italy, 80078
    - P.O. "S. Maria Delle Grazie" - Pozzuoli - ASL Napoli Nord 2
- RA
  - Faenza, RA, Italy, 48018
    - AUSL della Romagna - Ospedale degli infermi
- ROMA
  - Rome, ROMA, Italy, 00168
    - Fondazione Policlinico Agostino Gemelli IRCCS
- Ravenna
  - Lugo, Ravenna, Italy, 48022
    - AUSL Romagna - Presidio Ospedale "Umberto I" di Lugo
- Tuscany
  - Florence, Tuscany, Italy, 50134
    - Azienda Ospedaliero Universitaria Careggi-SODc Oncologia Clinica (Padiglione16)
Japan
- - Kumamoto, Japan, 860-0008
    - National Hospital Organization Kumamoto Medical Center
  - Yamagata, Japan, 990-9585
    - Yamagata University Hospital
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center
- Gunma
  - Ota-Shi, Gunma, Japan, 373-8550
    - Gunma Prefectural Cancer Center
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0017
    - Kobe University Hospital
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8576
    - University of Tsukuba Hospital
- Kagawa-ken
  - Kita-gun, Kagawa-ken, Japan, 761-0793
    - Kagawa University Hospital
- Kanagawa
  - Yokohama, Kanagawa, Japan, 232-0024
    - Yokohama City University Medical Center
  - Yokohama, Kanagawa, Japan, 241-8515
    - Kanagawa cancer center
- Tokushima
  - Tokushima, Tokushima, Japan, 770-8503
    - Tokushima University Hospital
- Wakayama
  - Wakayama, Wakayama, Japan, 641-8510
    - Wakayama Medical University Hospital
- Yamaguchi
  - Ube, Yamaguchi, Japan, 755-8505
    - Yamaguchi University Hospital
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Netherlands Cancer Institute/Antoni van Leeuwenhoek
  - Amsterdam, Netherlands, 1066 CX
    - Antoni van Leeuwenhoek, expeditie Apotheek, Afdeling Studiemedicatie
  - Arnhem, Netherlands, 6815 AD
    - Rijnstate Hospital
  - Breda, Netherlands, 4818 CK
    - Amphia Ziekenhuis
  - Nijmegen, Netherlands, 6525GA
    - RadboudUMC medical Oncology
  - The Hague, Netherlands, 2545 AA
    - Stichting HagaZiekenhuis
Peru
- - Lima, Peru, 15828
    - Hospital Maria Auxiliadora
  - Lima, Peru, 15076
    - Hospital Militar Central Coronel Luis Arias Schreiber
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Lisbon, Portugal, 1649-028
    - Hospital de Santa Maria
  - Lisbon, Portugal, 1400-038
    - Champalimaud Clinical Center
  - Lisbon, Portugal, 1400, 038
    - Centro Clinico Champalimaud
  - Lisbon, Portugal, 1649-028
    - Hospital de Santa Maria - Centro Hospitalar Universitario Lisboa Norte
- Braga District
  - Sao Victor, Braga District, Portugal, 4710-243
    - Hospital de Braga
Singapore
- - Singapore, Singapore, 188770
    - Raffles Hospital
  - Singapore, Singapore, 168583
    - National Cancer Centre Singapore
South Korea
- - Busan, South Korea, 48108
    - Inje University Haeundae Paik Hospital
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Seoul, South Korea, 03722
    - Severance Hospital Yonsei University Health System
  - Seoul, South Korea, 02841
    - Korea University Anam Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center - Oncology
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10408
    - National Cancer Center
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seongnam-si, Gyeonggi-do, South Korea, 13496
    - Cha Bundang Medical Center, Cha University
  - Suwon, Gyeonggi-do, South Korea, 16247
    - The Catholic University of Korea, St. Vincent'S Hospital
- Jeollanam-do
  - Hwasun-gun, Jeollanam-do, South Korea, 58128
    - Chonnam National University Hwasun Hospital
- Jeonlabuk-do
  - Iksan-si, Jeonlabuk-do, South Korea, 54538
    - Wonkwang University Hospital
Spain
- - Badajoz, Spain, 06080
    - HUB-Hospital Universitario Badajoz
  - Badajoz, Spain, 06080
    - Infanta Cristina Hospital
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08036
    - Hospital Clinic De Barcelona
  - Barcelona, Spain, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 08041
    - Hospital De La Santa Creu I Sant Pau
  - Barcelona, Spain, 08035
    - Hospital Universitari Vall d Hebron
  - Barcelona, Spain, 08029
    - ASCIRES CETIR Viladomat
  - Barcelona, Spain, 08041
    - Hospital de la Santa Creu i Sant Pau- Pharmacy
  - Barcelona, Spain, 08023
    - Imagen en Ensayos Clinicos S.L.
  - L'Hospitaler de Llobregat, Spain, 08908
    - Unitat d'Assajos Clinics Servei de Farmacia
  - Las Palmas de Gran Canaria, Spain, 35016
    - Complejo Hospitalario Universitario Insular Materno-Infantil
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28006
    - Hospital Universitario de la Princesa
  - Madrid, Spain, 28033
    - MD Anderson Cancer Center Madrid
  - Madrid, Spain, 28009
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28050
    - Hospital Universitario HM Sanchinarro
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz: Servicio de Farmacia
  - Madrid, Spain, 28027
    - Clinica Fuensanta
  - Madrid, Spain, 28006
    - Hospital Universitario Nuestra Señora del Rosario
  - Ourense, Spain, 32005
    - Complejo Hospitalario Universitario de Ourense (CHOU)
  - Oviedo, Spain, 33011
    - Hospital Universitario Central de Asturias
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spain, 46014
    - Consorcio Hospital General Universitario de Valencia (CHGUV)
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Complejo Hospitalario Universitario de Santiago
  - Santiago de Compostela, A Coruna, Spain, Spain
    - Farmacia Oncologica - Unidad de Ensayos Clinicos
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Institut Catala d' Oncologia de Badalona - Hospital Universitari Germans Trias i Pujos
  - Badalona, Barcelona, Spain, 08916
    - Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
- Bizkaia
  - Barakaldo, Bizkaia, Spain, 48903
    - Hospital de Cruzes
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Hospital Universitario Marques de Valdecilla
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Majadahonda
Sweden
- - Jönköping, Sweden, 551 85
    - Ryhov Hospital
  - Stockholm, Sweden, 171 76
    - Karolinska University Hospital
Taiwan
- - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital - Pharmacy
  - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital Clinical Trials Pharmacy
  - Tainan, Taiwan, 704
    - National Cheng-Kung University Hospital
  - Tainan, Taiwan, 704017
    - Clinical Trial Pharmacy, Department of Pharmacy, National Cheng Kung University Hospital
  - Tainan, Taiwan, 73657
    - Chi Mei Hospital Liouying
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital, Investigational Drug Service
  - Taoyuan, Taiwan, 333
    - Linkou Chang Gung Memorial Hospital
  - Taoyuan, Taiwan, 333
    - Linkou Chang Gung Memorial Hospital - Clinical Trial Pharmacy
- Kaohsiung
  - Kaoshiung, Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
- Taiwan (r.o.c.)
  - Taichung, Taiwan (r.o.c.), Taiwan, 40447
    - China Medical University Hospital
United Kingdom
- - London, United Kingdom, E1 1FR
    - Barts Health NHS Trust , The Royal London Hospital
  - London, United Kingdom, EC1A /7BE
    - Barts Health NHS Trust Saint Bartholomews Hospital
United States
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Banner MD Anderson Cancer Center
  - Gilbert, Arizona, United States, 85234
    - Banner Gateway Medical Center
- California
  - Alhambra, California, United States, 91801
    - UCLA Hematology/Oncology - Alhambra
  - Arcadia, California, United States, 91007
    - Foothill Cardioology
  - Beverly Hills, California, United States, 90211
    - Beverly Hills Multi-Specialties Practice
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center
  - Burbank, California, United States, 91505
    - UCLA Hematology/Oncology - Burbank
  - Burbank, California, United States, 91505
    - UCLA Burbank Cardiology
  - Calabasas, California, United States, 91302
    - UCLA Calabasas Specialty Care
  - Encino, California, United States, 91436
    - UCLA Hematology/Oncology - Encino
  - Encino, California, United States, 91436
    - UCLA Encino Specialty Care (Radiology)
  - Fountain Valley, California, United States, 92708
    - Helios Clinical Research
  - Glendale, California, United States, 91204
    - Helios Clinical Research
  - Glendora, California, United States, 91741
    - Foothill Cardiology Glendora
  - Long Beach, California, United States, 90805
    - Helios Clinical Research
  - Los Angeles, California, United States, 90095
    - UCLA Hematology & Oncology Clinic
  - Los Angeles, California, United States, 90095
    - UCLA Department of Medicine-Hematology/Oncology
  - Los Angeles, California, United States, 90095
    - UCLA Cardiovascular Center
  - Los Angeles, California, United States, 90017
    - UCLA Downtown Los Angeles Primary & Specialty Care
  - Los Angeles, California, United States, 90095
    - UCLA Hematology / Oncology
  - Los Angeles, California, United States, 90095
    - UCLA Westwood Specialty Care
  - Montecito, California, United States, 93108
    - UCLA Montecito Primary & Specialty Care
  - Monterey, California, United States, 93940
    - Pacific Cancer Care
  - Newport Beach, California, United States, 92660
    - Newport Diagnostics
  - Pasadena, California, United States, 91105
    - Southern California Heart Specialists
  - Pasadena, California, United States, 91105
    - Foothill Cardiology Pasadena
  - Porter Ranch, California, United States, 91326
    - UCLA Porter Ranch Primary & Specialty Care
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94143
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94158
    - University of California San Francisco
  - San Francisco, California, United States, 94158
    - UCSF Investigational Drugs Pharmacy
  - San Francisco, California, United States, 94158
    - University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
  - San Francisco, California, United States, 94158
    - UCSF Mission Bay Pediatric Clinical Research Center
  - San Francisco, California, United States, 94107
    - UCSF Center at China Basin Imaging
  - San Francisco, California, United States, 94115
    - Helen Diller Family Comprehensive Cancer Center - Imaging Post
  - San Francisco, California, United States, 94115
    - UCSF Cancer Center MZ Phlebotomy
  - San Francisco, California, United States, 94115
    - UCSF Mount Zion Phlebotomy
  - San Francisco, California, United States, 94143
    - UCSF Parnassus Phlebotomy
  - San Francisco, California, United States, 94143
    - UCSF Parnassus-5 Lab
  - San Francisco, California, United States, 94158
    - Cardiovascular Care and Prevention Center at Mission Bay
  - San Francisco, California, United States, 94158
    - UCSF Mission Bay Gateway-2 Lab
  - San Francisco, California, United States, 94158
    - UCSF Mission Bay PCMB-5 Lab
  - San Francisco, California, United States, 94158
    - UCSF Mission Bay Radiology and Nuclear Medicine
  - San Francisco, California, United States, 94160
    - The Regents of the University of California
  - San Gabriel, California, United States, 91776
    - Diagnostic Medical Group of Southern California, , San Gabriel, CA
  - San Gabriel, California, United States, 91776
    - Southern California Heart Centers
  - San Luis Obispo, California, United States, 93405
    - Sierra Vista Regional Medical Center
  - San Luis Obispo, California, United States, 93401
    - UCLA Hematology/Oncology - San Luis Obispo
  - Santa Ana, California, United States, 92705
    - Helios Clinical Research
  - Santa Barbara, California, United States, 93105
    - UCLA Hematology/Oncology - Santa Barbara
  - Santa Monica, California, United States, 90404
    - UCLA Santa Monica Cardiology
  - Simi Valley, California, United States, 93065
    - UCLA Simi Valley Alamo Specialty Care
  - Templeton, California, United States, 93455
    - Twin Cities Community Hospital
  - Thousand Oaks, California, United States, 91360
    - UCLA Thousand Oaks Primary & Specialty Care
  - Torrance, California, United States, 90505
    - UCLA Hematology/Oncology - Torrance
  - Torrance, California, United States, 90505
    - UCLA Torrance Lomita Specialty Care
  - Valencia, California, United States, 91355
    - UCLA Santa Clarita Primary & Specialty Care
  - Ventura, California, United States, 93003
    - UCLA Ventura Cardiology
  - Westlake Village, California, United States, 91361
    - UCLA Hematology/Oncology - Westlake
  - Whittier, California, United States, 90602
    - Helios Clinical Research
- Minnesota
  - Bloomington, Minnesota, United States, 55425
    - HealthPartners Institute
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology Hematology, PA
  - Coon Rapids, Minnesota, United States, 55433
    - Minnesota Oncology Hematology, PA
  - Coon Rapids, Minnesota, United States, 55433
    - Allina Health Cancer institute
  - Edina, Minnesota, United States, 55435
    - M Health Fairview Cancer Clinic-Edina
  - Edina, Minnesota, United States, 55435
    - Minnesota Oncology Hematology PA
  - Fridley, Minnesota, United States, 55432
    - Minnesota Oncology Hematology, PA
  - Maplewood, Minnesota, United States, 55109
    - M Health Fairview St. John's Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, PA
  - Minneapolis, Minnesota, United States, 55404
    - Minnesota Oncology Hematology, PA
  - Minneapolis, Minnesota, United States, 55404
    - Allina Health Cancer Institute-United(VPCI)
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin Country Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Health Cancer Center
  - Saint Louis Park, Minnesota, United States, 55426
    - Park Nicollet Frauenshuh Cancer Center
  - Saint Louis Park, Minnesota, United States, 55426
    - Metro Minnesota Community Oncology Research Consortium(MMCORC)
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - Allina Health Cancer Institute-United(VPCI)
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA
- Pennsylvania
  - Erie, Pennsylvania, United States, 16544
    - AHN Saint Vincent Hospital
  - Jefferson Hills, Pennsylvania, United States, 15025
    - AHN Jefferson Hospital
  - Monroeville, Pennsylvania, United States, 15146
    - AHN Forbes Hospital
  - Natrona Heights, Pennsylvania, United States, 15065
    - Allegheny Valley Hospital
  - Pittsburgh, Pennsylvania, United States, 15224
    - AHN West Penn Hospital
  - Pittsburgh, Pennsylvania, United States, 15212
    - AHN Cancer Institute - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15212
    - AHN Cancer Institute Pharmacy
- Texas
  - Fort Worth, Texas, United States, 76104
    - Helios Clinical Research
- Washington
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Center.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
Measurable disease by investigator assessment per RECIST v1.1.
Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.
Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to treatment initiation. If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.
HER2 expression of 1+ or greater on immunohistochemistry (IHC).
Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.

Exclusion Criteria:

Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.
Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.
- CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
- Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.
History of or active autoimmune disease that has required systemic treatment in the past 2 years.
Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).
Prior solid organ or bone marrow transplantation.
Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
Estimated life expectancy <12 week
Prior treatment with an MMAE agent or anti-HER2 therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disitamab vedotin arm disitamab vedotin + pembrolizumab	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks Other Names: RC48, RC48-ADC Drug: pembrolizumab 400mg given by IV every 6 weeks Other Names: KEYTRUDA®
Active Comparator: Standard of care arm gemcitabine + cisplatin OR carboplatin	Drug: gemcitabine 1000 mg/m^2 given by IV on days 1 and 8 of every 3-week cycle Other Names: Gemzar Drug: cisplatin 70 mg^2 given by IV on day 1 of every 3-week cycle Drug: carboplatin Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) Time Frame: Approximately 3 years	The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.	Approximately 3 years
Overall survival (OS) Time Frame: Approximately 5 years	The time from date of randomization to date of death due to any cause.	Approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) per RECIST v1.1 by BICR Time Frame: Approximately 3 years	The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.	Approximately 3 years
ORR per RECIST v1.1 by investigator assessment Time Frame: Approximately 3 years	The proportion of participants with confirmed CR or PR according to RECIST v1.1.	Approximately 3 years
Duration of Response (DOR) per RECIST v1.1 by BICR Time Frame: Approximately 3 years	The time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause.	Approximately 3 years
DOR per RECIST v1.1 by investigator assessment Time Frame: Approximately 3 years	The time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause.	Approximately 3 years
Control Rate (DCR) per RECIST v1.1 by BICR Time Frame: Approximately 3 years	The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.	Approximately 3 years
DCR per RECIST v1.1 by investigator assessment Time Frame: Approximately 3 years	The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.	Approximately 3 years
PFS per RECIST v1.1 by investigator assessment Time Frame: Approximately 3 years	The time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause.	Approximately 3 years
Number of participants with adverse events (AEs) Time Frame: Through 30 days after the last study treatment; approximately 2 years	Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Through 30 days after the last study treatment; approximately 2 years
Number of participants with laboratory abnormalities Time Frame: Through 30 days after the last study treatment; approximately 2 years		Through 30 days after the last study treatment; approximately 2 years
Treatment discontinuation rate due to AEs Time Frame: Approximately 2 years		Approximately 2 years
Number of electrocardiogram (ECG) abnormalities Time Frame: Through 30 days after the last study treatment; approximately 2 years		Through 30 days after the last study treatment; approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF) Time Frame: Through 2 years after last study treatment; approximately 4 years		Through 2 years after last study treatment; approximately 4 years
Change from baseline to Week 16 in European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score Time Frame: Approximately 2 years	The EORTC QLQ-C30 is used to evaluate health-related quality of life, functioning, disease symptoms, and treatment-related side effects. Scores range from 0-100. For GHS/QoL and functional scales, higher scores represent higher QoL or functioning. For symptom scales, higher scores represent more symptoms/worse status.	Approximately 2 years
Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score Time Frame: Approximately 2 years	The time from the date of randomization to the date of first deterioration (change from baseline ≥10) in GHS/QoL score with no subsequent recovery. The EORTC QLQ-C30 is used to evaluate health-related quality of life, functioning, disease symptoms, and treatment-related side effects. Scores range from 0-100. For GHS/QoL and functional scales, higher scores represent higher QoL or functioning. For symptom scales, higher scores represent more symptoms/worse status.	Approximately 2 years
Time to pain progression Time Frame: Approximately 2 years	The time from the date of randomization to whichever of the following occurs earlier: an increase in Numeric Rating Scale (NRS) for pain intensity of 2 points or more from baseline at 2 consecutive visits, an increase in number of opioid or analgesic use from baseline, or initiation of opioid or analgesic use. NRS for pain intensity asks participants to best describe their pain at its worst in the last 24 hours from 0 to 10. On the NRS, 0 means no pain and 10 means pain as bad as you can imagine.	Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Collaborators

Merck Sharp & Dohme LLC

RemeGen Co., Ltd.

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SGNDV-001
C5731001 (Other Identifier: Alias Study Number)
2022-501105-12-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Urothelial Carcinoma

Clinical Trials on disitamab vedotin

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