AzTrials
AzTrials

Urothelial CarcinomaPhase 3NCT05911295

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

A Phase 3 study testing disitamab vedotin, pembrolizumab and gemcitabine in people with Urothelial Carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer at 268 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
disitamab vedotin, pembrolizumab and gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
268 sitesin 24 countries
Study dates
22 Sep 2023to 30 Apr 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

268 sites in 24 countries.

268 sites in 24 countries

United States89 sites

  • UCLA Hematology/Oncology - Alhambra

    Alhambra, California, 91801

  • Foothill Cardioology

    Arcadia, California, 91007

  • Beverly Hills Multi-Specialties Practice

    Beverly Hills, California, 90211

  • HealthPartners Institute

    Bloomington, Minnesota, 55425

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • UCLA Burbank Cardiology

    Burbank, California, 91505

  • UCLA Hematology/Oncology - Burbank

    Burbank, California, 91505

  • Minnesota Oncology Hematology, PA

    Burnsville, Minnesota, 55337

  • UCLA Calabasas Specialty Care

    Calabasas, California, 91302

  • Allina Health Cancer Institute

    Coon Rapids, Minnesota, 55433

  • Minnesota Oncology Hematology, PA

    Coon Rapids, Minnesota, 55433

  • M Health Fairview Cancer Clinic-Edina

    Edina, Minnesota, 55435

  • Minnesota Oncology Hematology Pa

    Edina, Minnesota, 55435

  • UCLA Encino Specialty Care (Radiology)

    Encino, California, 91436

  • UCLA Hematology/Oncology - Encino

    Encino, California, 91436

  • AHN Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • Helios Clinical Research

    Fort Worth, Texas, 76104

  • Helios Clinical Research

    Fountain Valley, California, 92708

  • Minnesota Oncology Hematology, PA

    Fridley, Minnesota, 55432

  • Banner Gateway Medical Center

    Gilbert, Arizona, 85234

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Helios Clinical Research

    Glendale, California, 91204

  • Foothill Cardiology Glendora

    Glendora, California, 91741

  • AHN Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

  • Helios Clinical Research

    Long Beach, California, 90805

  • UCLA Downtown Los Angeles Primary & Specialty Care

    Los Angeles, California, 90017

  • UCLA Cardiovascular Center

    Los Angeles, California, 90095

  • UCLA Department of Medicine-Hematology/Oncology

    Los Angeles, California, 90095

  • UCLA Hematology & Oncology Clinic

    Los Angeles, California, 90095

  • UCLA Hematology / Oncology

    Los Angeles, California, 90095

  • UCLA Westwood Specialty Care

    Los Angeles, California, 90095

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA

    Maplewood, Minnesota, 55109

  • Allina Health Cancer Institute-United(VPCI)

    Minneapolis, Minnesota, 55404

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Hennepin Country Medical Center

    Minneapolis, Minnesota, 55415

  • AHN Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • UCLA Montecito Primary & Specialty Care

    Montecito, California, 93108

  • Pacific Cancer Care

    Monterey, California, 93940

  • Allegheny Valley Hospital

    Natrona Heights, Pennsylvania, 15065

  • Newport Diagnostics

    Newport Beach, California, 92660

  • Foothill Cardiology Pasadena

    Pasadena, California, 91105

  • Southern California Heart Specialists

    Pasadena, California, 91105

  • AHN Cancer Institute - Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • AHN Cancer Institute Pharmacy

    Pittsburgh, Pennsylvania, 15212

  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • UCLA Porter Ranch Primary & Specialty Care

    Porter Ranch, California, 91326

  • North Memorial Health Cancer Center

    Robbinsdale, Minnesota, 55422

  • Metro Minnesota Community Oncology Research Consortium(MMCORC)

    Saint Louis Park, Minnesota, 55426

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Allina Health Cancer Institute-United(VPCI)

    Saint Paul, Minnesota, 55102

  • UCSF Center at China Basin Imaging

    San Francisco, California, 94107

  • Helen Diller Family Comprehensive Cancer Center - Imaging Post

    San Francisco, California, 94115

  • UCSF Cancer Center MZ Phlebotomy

    San Francisco, California, 94115

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • UCSF Mount Zion Phlebotomy

    San Francisco, California, 94115

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • UCSF Parnassus Phlebotomy

    San Francisco, California, 94143

  • UCSF Parnassus-5 Lab

    San Francisco, California, 94143

  • Cardiovascular Care and Prevention Center at Mission Bay

    San Francisco, California, 94158

  • UCSF Investigational Drugs Pharmacy

    San Francisco, California, 94158

  • UCSF Mission Bay Gateway-2 Lab

    San Francisco, California, 94158

  • UCSF Mission Bay PCMB-5 Lab

    San Francisco, California, 94158

  • UCSF Mission Bay Pediatric Clinical Research Center

    San Francisco, California, 94158

  • UCSF Mission Bay Radiology and Nuclear Medicine

    San Francisco, California, 94158

  • University of California San Francisco

    San Francisco, California, 94158

  • University of California, San Francisco | HDFCCC - Hematopoietic malignancies

    San Francisco, California, 94158

  • The Regents of the University of California

    San Francisco, California, 94160

  • Diagnostic Medical Group of Southern California, , San Gabriel, CA

    San Gabriel, California, 91776

  • Southern California Heart Centers

    San Gabriel, California, 91776

  • UCLA Hematology/Oncology - San Luis Obispo

    San Luis Obispo, California, 93401

  • Sierra Vista Regional Medical Center

    San Luis Obispo, California, 93405

  • Helios Clinical Research

    Santa Ana, California, 92705

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California, 93105

  • UCLA Santa Monica Cardiology

    Santa Monica, California, 90404

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center.

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • UCLA Simi Valley Alamo Specialty Care

    Simi Valley, California, 93065

  • Twin Cities Community Hospital

    Templeton, California, 93455

  • UCLA Thousand Oaks Primary & Specialty Care

    Thousand Oaks, California, 91360

  • UCLA Hematology/Oncology - Torrance

    Torrance, California, 90505

  • UCLA Torrance Lomita Specialty Care

    Torrance, California, 90505

  • UCLA Santa Clarita Primary & Specialty Care

    Valencia, California, 91355

  • UCLA Ventura Cardiology

    Ventura, California, 93003

  • UCLA Hematology/Oncology - Westlake

    Westlake Village, California, 91361

  • Helios Clinical Research

    Whittier, California, 90602

  • Minnesota Oncology Hematology, PA

    Woodbury, Minnesota, 55125

Other trials in United States

Spain32 sites

  • HUB-Hospital Universitario Badajoz

    Badajoz, 06080

  • Infanta Cristina Hospital

    Badajoz, 06080

  • Institut Catala d' Oncologia de Badalona - Hospital Universitari Germans Trias i Pujos

    Badalona, Barcelona, 08916

  • Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Cruzes

    Barakaldo, Bizkaia, 48903

  • Hospital del Mar

    Barcelona, 08003

  • Imagen en Ensayos Clinicos S.L.

    Barcelona, 08023

  • ASCIRES CETIR Viladomat

    Barcelona, 08029

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau- Pharmacy

    Barcelona, 08041

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041

  • Unitat d'Assajos Clinics Servei de Farmacia

    L'Hospitaler de Llobregat, 08908

  • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Complejo Hospitalario Universitario Insular Materno-Infantil

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Nuestra Señora del Rosario

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Clinica Fuensanta

    Madrid, 28027

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz: Servicio de Farmacia

    Madrid, 28046

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Ourense (CHOU)

    Ourense, 32005

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Consorcio Hospital General Universitario de Valencia (CHGUV)

    Valencia, 46014

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Australia17 sites

  • Mater Misericordiae - Mater Hospital Brisbane

    Brisbane, Queensland, 4101

  • South Eastern Sydney Local Health District

    Caringbah, 2229

  • ICON Cancer Centre Chermside

    Chermside, Queensland, 4032

  • Concord Cancer Centre Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Saint Vincents Hospital Sydney - Human Research Ethics Committee

    Darlinghurst, New South Wales, 2010

  • St Vincent's Clinic

    Darlinghurst, New South Wales, 2010

  • Lyell McEwin Hospital

    Elizabeth Vale, 5112

  • Peninsula & South Eastern Hematology and Oncology Group (PASO)

    Frankston, Victoria, 3199

  • Peninsula And South East Oncology

    Frankston, 3199

  • Icon Cancer Centre Chermside

    Herston, Queensland, 4029

  • Macquarie University Hospital

    Macquarie University, New South Wales, 2109

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Macquarie University

    North Ryde, New South Wales, 2109

  • Mid North Coast Local Health District

    NSW, NSW 2450

  • Port Macquarie Base Hospital

    Port Macquarie, 2444

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Mater Research

    South Bribane, Queensland, 4101

Other trials in Australia

Italy17 sites

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    Bari, Other, 70124

  • ASST Cremona Farmacia Ospedaliera

    Cremona, 26100

  • AUSL della Romagna - Ospedale degli infermi

    Faenza, RA, 48018

  • Azienda Ospedaliero Universitaria Careggi-SODc Oncologia Clinica (Padiglione16)

    Florence, Tuscany, 50134

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • Azienda Sanitaria Locale Napoli 2 Nord

    Giugliano in Campania, Naples, 80014

  • IRCCS San Raffaele Hospital ,Genitourinary medical Oncology

    Lombardy, Milan, 20132

  • AUSL Romagna - Presidio Ospedale "Umberto I" di Lugo

    Lugo, Ravenna, 48022

  • Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

    Pisa, 56126

  • P.O. "S. Maria Delle Grazie" - Pozzuoli - ASL Napoli Nord 2

    Pozzuoli (NA), Other, 80078

  • Unita Operative di Oncologia,Ospedale S.Maria delle Croci

    Ravenna, 48121

  • Fondazione Policlinico Agostino Gemelli IRCCS

    Rome, ROMA, 00168

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • SC ONCOLOGYA Medica e Traslazionale Azienda Ospedaliera S.Maria di terni

    Terni, 05100

  • Azienda Ospedaliera Cardinale Giovanni Panico

    Tricase, Apulia, 73039

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37124

  • Centro Ricerche Cliniche Di Verona Srl

    Verona, 37134

Other trials in Italy

Argentina16 sites

  • Centro de Oncologia e Investigacion de Buenos Aires (COIBA)

    Berazategui, B1884BBF

  • Centro Medico Austral

    Buenos Aire, C1019ABS

  • Centro de Investigaciones Medicas y Desarrollo LC

    Buenos Aires, Buenos Aires F.D., 1113

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires, C1426ANZ

  • Centro Oncologico Korben

    Buenos Aires

  • Investigaciones Clinicas Moleculares (ICM)

    CABA, 1425

  • Labmedicina

    CABA, C1430EFA

  • CEMAIC - Centro Medico Privado

    Córdoba, X5008AAC

  • Centro de Investigacion Pergamino SA

    Pergamino, Buenos Aires, 2700

  • Sanatorio Parque

    Rosario, Santa Fe Province, S2000DSV

  • Comité Provincial de Bioética-Rosario

    Rosario, 2000

  • Grupo de Investigación en Oncología Clínica del Santario Parque

    Rosario, 2000

  • Consultorio Dr. Miguel Angel Escudero

    Salta, 4400

  • Oncologia Salta

    Salta, 4400

  • Fundación Dr. Ruben Kowalyszyn

    Viedma, Río Negro Province, 8500

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Brazil14 sites

  • Hospital de Cancer de Barretos - Fundacao Pio XII

    Barretos, 14784-400

  • Associacao Mario Penna - Hospital Luxemburgo - NEPI Nucleo de Ensino Pesquisa e Inovacao

    Belo Horizonte, Minas Gerais, 30380472

  • Erasto Gaertner Hospital

    Curitiba, Paraná, 81520-060

  • Suporte Nutricional e Quimioterapia - PRONUTRIR

    Fortaleza, Ceará, 60810-180

  • Fundacao Doutor Amaral Carvalho

    Jaú, São Paulo, 17210080

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-090

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610000

  • Hospital Nossa Senhora da Conceicao / Grupo Hospitalar Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional De Cancer - INCA

    Rio de Janeiro, 20230-130

  • Instituto Nacional De Cancer - INCA

    Rio de Janeiro, 20231-050

  • Centro de Oncologia da Bahia

    Salvador, 41820021

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327-001

Other trials in Brazil

Japan12 sites

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Gunma Prefectural Cancer Center

    Ota-Shi, Gunma, 373-8550

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Taiwan12 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaoshiung, Kaohsiung, 807

  • China Medical University Hospital

    Taichung, Taiwan (r.o.c.), 40447

  • China Medical University Hospital - Pharmacy

    Taichung, 40447

  • Taichung Veterans General Hospital Clinical Trials Pharmacy

    Taichung, 40705

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Clinical Trial Pharmacy, Department of Pharmacy, National Cheng Kung University Hospital

    Tainan, 704017

  • National Cheng-Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital liouying

    Tainan, 73657

  • National Taiwan University Hospital, Investigational Drug Service

    Taipei, 100

  • National Taiwan University Hospital

    Taipei, 100

  • Linkou Chang Gung Memorial Hospital - Clinical Trial Pharmacy

    Taoyuan City, 333

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333

Other trials in Taiwan

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128

  • Wonkwang University Hospital

    Iksan-si, Jeonlabuk-do, 54538

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center - Oncology

    Seoul, 05505

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

Other trials in South Korea

Israel8 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Hafia, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, Other, 9103102

  • Hadassah University Hospital at Ein Kerem

    Jerusalem, 9112001

  • Meir Medical Center

    Kefar Sava, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center.

    Ramat Gan, Other, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Netherlands7 sites

  • Antoni van Leeuwenhoek Apotheek,I-2

    Amsterdam, 1066 CX

  • Antoni van Leeuwenhoek, expeditie Apotheek, Afdeling Studiemedicatie

    Amsterdam, 1066 CX

  • Netherlands Cancer Institute/Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • RadboudUMC medical Oncology

    Nijmegen, 6525GA

  • Stichting HagaZiekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

Canada5 sites

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • University of Alberta / Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)

    Oshawa, Ontario, L1G 2B9

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France5 sites

  • Institut Bergonié Centre de Lutte Contre le Cancer (CLCC)

    Bordeaux, 33076

  • Hospices Civils de Lyon - Hopitale Lyon Sud

    Pierre-Bénite, Rhône, 69310

  • Unite de Coordination de la Biologie des Essais Cliniques

    Strasbourg, 67091

  • Institut de Cancerologie Strasbourg Europe

    Strasbourg, 67200

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Portugal4 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Clinico Champalimaud

    Lisbon, 1400, 038

  • Champalimaud Clinical Center

    Lisbon, 1400-038

  • Hospital de Santa Maria

    Lisbon, 1649-035

Other trials in Portugal

Belgium3 sites

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, 9000

  • AZ St. Lucas

    Ghent, 9000

  • University Hospital Ghent

    Ghent, 9000

Other trials in Belgium

Chile3 sites

  • Centro de Oncologia de Precision

    Los Condes, Region Metropolitana Santiago, 7560908

  • Fundacion Arturo Lopez Perez

    Providencia, Santiago Metropolitan, 7500921

  • Centro de Investigacion Clinica Bradford Hill

    Santiago, Santiago Metropolitan, 8420383

Other trials in Chile

Czechia2 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05

  • Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

    Olomouc, 779 00

Other trials in Czechia

Hungary2 sites

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemét, 6000

Other trials in Hungary

Peru2 sites

  • Hospital Militar Central Coronel Luis Arias Schreiber

    Lima, 15076

  • Hospital Maria Auxiliadora

    Lima, 15828

Other trials in Peru

Sweden2 sites

  • Ryhov Hospital

    Jönköping, 551 85

  • Karolinska University Hospital

    Stockholm, 171 76

Other trials in Sweden

United Kingdom2 sites

  • Barts Health NHS Trust , The Royal London Hospital

    London, E1 1FR

  • Barts Health NHS Trust Saint Bartholomews Hospital

    London, EC1A /7BE

Other trials in United Kingdom

Greece1 site

  • Athens Medical Center

    Marousi, Attikí, 151 25

Other trials in Greece

Ireland1 site

  • Tallaght University Hospital

    Tallaght, D24 NR0A

Other trials in Ireland

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

About this study

Official title: 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.

Being tested
disitamab vedotin, pembrolizumab, gemcitabine, cisplatin, carboplatin
Keywords
Urothelial Cancer, LA/mUC, Bladder Cancer, HER2 Overexpression, HER2 Amplification, HER2, Seattle Genetics
Medical subject headings
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • disitamab vedotinDrug

    Also called RC48, RC48-ADC

    Given into the vein (IV; intravenous) every 2 weeks

  • pembrolizumabDrug

    Also called KEYTRUDA®

    400mg given by IV every 6 weeks

  • gemcitabineDrug

    Also called Gemzar

    1000 mg/m^2 given by IV on days 1 and 8 of every 3-week cycle

  • cisplatinDrug

    70 mg^2 given by IV on day 1 of every 3-week cycle

  • carboplatinDrug

    Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle

Study groups in NCT05911295
Study groupRoleWhat they receive
Disitamab vedotin armExperimentaldisitamab vedotin + pembrolizumab
Receives: Drug: disitamab vedotin; Drug: pembrolizumab
Standard of care armActive comparatorgemcitabine + cisplatin OR carboplatin
Receives: Drug: gemcitabine; Drug: cisplatin; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)

    The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.

    Measured: Approximately 3 years

  2. Overall survival (OS)

    The time from date of randomization to date of death due to any cause.

    Measured: Approximately 5 years

Secondary outcomes (15)

  1. Objective response rate (ORR) per RECIST v1.1 by BICR

    The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.

    Measured: Approximately 3 years

  2. ORR per RECIST v1.1 by investigator assessment

    The proportion of participants with confirmed CR or PR according to RECIST v1.1.

    Measured: Approximately 3 years

  3. Duration of Response (DOR) per RECIST v1.1 by BICR

    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.

    Measured: Approximately 3 years

  4. DOR per RECIST v1.1 by investigator assessment

    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.

    Measured: Approximately 3 years

  5. Control Rate (DCR) per RECIST v1.1 by BICR

    The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.

    Measured: Approximately 3 years

  6. DCR per RECIST v1.1 by investigator assessment

    The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.

    Measured: Approximately 3 years

  7. PFS per RECIST v1.1 by investigator assessment

    The time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause.

    Measured: Approximately 3 years

  8. Number of participants with adverse events (AEs)

    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.

    Measured: Through 30 days after the last study treatment; approximately 2 years

  9. Number of participants with laboratory abnormalities

    Measured: Through 30 days after the last study treatment; approximately 2 years

  10. Treatment discontinuation rate due to AEs

    Measured: Approximately 2 years

  11. Number of electrocardiogram (ECG) abnormalities

    Measured: Through 30 days after the last study treatment; approximately 2 years

  12. Change from baseline of left ventricular ejection fraction (LVEF)

    Measured: Through 2 years after last study treatment; approximately 4 years

  13. 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

    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.

    Measured: Approximately 2 years

  14. Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score

    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.

    Measured: Approximately 2 years

  15. Time to pain progression

    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.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start22 Sep 2023
  3. Primary completion29 Jan 2027 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05911295
Sponsor's protocol ID
SGNDV-001
Other IDs
C5731001, 2022-501105-12-00
Status last verified
Jul 2026
First submitted
9 Jun 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing disitamab vedotin, pembrolizumab and gemcitabine in people with Urothelial Carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer at 268 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Spain, Australia, Italy, Argentina and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05911295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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