A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

April 20, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Study Overview

Status

Recruiting

Conditions

Urothelial Carcinoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

372

Phase

Phase 2

Contacts and Locations

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

Study Contact

Name: Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1118AAT
    - Recruiting
    - Hospital Aleman
  - Buenos Aires, Argentina, C1426ANZ
    - Recruiting
    - Instituto Medico Especializado Alexander Fleming
  - Buenos Aires, Argentina, ZC 1419
    - Recruiting
    - Hospital Sirio Libanes - Buenos Aires
  - CABA, Argentina, C1019ABS
    - Recruiting
    - Centro Medico Austral
  - Caba, Argentina, ZC 1426
    - Recruiting
    - Centro Oncológico Korben
  - Córdoba, Argentina, X5000
    - Recruiting
    - Instituto Oncologico de Cordoba
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, 1113
    - Active, not recruiting
    - Centro de Investigaciones Médicas y Desarrollo LC S.R.L
- Río Negro Province
  - Viedma, Río Negro Province, Argentina, R8500ACE
    - Recruiting
    - Clinica Viedma
Australia
- - Elizabeth Vale, Australia, 5112
    - Recruiting
    - Lyell McEwin Hospital
- New South Wales
  - Alexandria, New South Wales, Australia, 2015
    - Recruiting
    - Cancer Care Research Pty Ltd (trading as GenesisCare)
  - St Leonards, New South Wales, Australia, 2065
    - Recruiting
    - GenesisCare - North Shore
  - Sydney, New South Wales, Australia, 2109
    - Recruiting
    - Macquarie University
- Queensland
  - Brisbane, Queensland, Australia, 4102
    - Recruiting
    - Metro South Hospital and Health Service
  - South Brisbane, Queensland, Australia, QLD 4101
    - Recruiting
    - Mater Cancer Care Centre, Mater Misericordiae Limited
- Victoria
  - Frankston, Victoria, Australia, 3199
    - Recruiting
    - Peninsula & South Eastern Haematology and Oncology Group
Belgium
- - Ghent, Belgium, 9000
    - Active, not recruiting
    - AZ Maria Middelares
  - Namur, Belgium, 5000
    - Active, not recruiting
    - CHU UCL Namur-Site de Saint Elisabeth
Canada
- Alberta
  - Calgary, Alberta, Canada, T3N 4N1
    - Recruiting
    - Arthur J.E. Child Comprehensive Cancer Centre
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Recruiting
    - BC Cancer - Vancouver
  - Vancouver, British Columbia, Canada, V5Z 1H7
    - Recruiting
    - BC Cancer - Vancouver Fairmont Medical Building
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Recruiting
    - CancerCare Manitoba
    - Principal Investigator:
      
      Joel Gingerich
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Jewish General Hospital
    - Principal Investigator:
      
      April Rose, MD, PhD
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Active, not recruiting
    - Centre integre universitaire de sante et de services sociaux de l'Estrie
Chile
- - Providencia, Chile, 8320000
    - Recruiting
    - Oncovida SA
- Coquimbo Region
  - La Serena, Coquimbo Region, Chile, 1720430
    - Recruiting
    - Centro de Estudios Clínicos IC La Serena Research
- Providencia
  - Santiago, Providencia, Chile, 8330032
    - Recruiting
    - Pontificia Universidad Catolica de Chile
Israel
- - Haifa, Israel, 3109601
    - Active, not recruiting
    - Rambam Health Care Campus
  - Petah Tikva, Israel, 4941492
    - Active, not recruiting
    - Rabin Medical Center
  - Ramat Gan, Israel, 52621
    - Active, not recruiting
    - Sheba Medical Center
  - Ramat Gan, Israel, 5265601
    - Active, not recruiting
    - The Chaim Sheba Medical Center
  - Tel Aviv, Israel, 6423906
    - Active, not recruiting
    - Tel Aviv Sourasky Medical Center
Italy
- - Milan, Italy, 20132
    - Active, not recruiting
    - IRCCS Ospedale San Raffaele, U.O. Farmacia Studi Clinici
  - Padova, Italy, 35128
    - Active, not recruiting
    - IOV-Istituto Oncologico Veneto IRCCS-U.O. Oncologia Medica 1-SC Farmacia
  - Pisa, Italy, 56126
    - Active, not recruiting
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00168
    - Active, not recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Terni, Italy, 05100
    - Active, not recruiting
    - Azienda Ospedaliera S. Maria Di Terni
  - Terni, Italy, 05100
    - Active, not recruiting
    - S.C. Farmacia Interna
- Lombardy
  - Milan, Lombardy, Italy, 20132
    - Active, not recruiting
    - Ospedale San Raffaele
- Pordenone
  - Aviano, Pordenone, Italy, 33184
    - Active, not recruiting
    - Centro di Riferimento Oncologico di Aviano
- ROME
  - Roma, ROME, Italy, 00168
    - Active, not recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Japan
- - Osaka, Japan, 541-8567
    - Active, not recruiting
    - Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Active, not recruiting
    - National Cancer Center Hospital East
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8543
    - Active, not recruiting
    - Sapporo Medical University Hospital
- Osaka
  - Suita-shi, Osaka, Japan, 565-0871
    - Active, not recruiting
    - Osaka University Hospital
- Tokushima
  - Tokushima, Tokushima, Japan, 770-8503
    - Active, not recruiting
    - Tokushima University Hospital
- Tokyo
  - Koto-ku, Tokyo, Japan, 135-8550
    - Active, not recruiting
    - The Cancer Institute Hospital of JFCR
Spain
- - Barcelona, Spain, 08035
    - Active, not recruiting
    - Hospital Universitari Vall d'Hebron
  - Madrid, Spain, 28033
    - Active, not recruiting
    - MD Anderson Cancer Center Madrid
  - Madrid, Spain, 28033
    - Active, not recruiting
    - MD Anderson Cancer Center - Madrid
  - Seville, Spain, 41013
    - Active, not recruiting
    - Hospital Universitario Virgen del Rocio
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Active, not recruiting
    - Hospital Universitari Parc Tauli Sabadell
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06620
    - Recruiting
    - Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Arastirma ve Uygulama Hastanesi
  - Edirne, Turkey (Türkiye), 22030
    - Recruiting
    - Trakya Universitesi Tip Fakultesi Hastanesi (Saglik Arastirma ve Uygulama Merkezi)
  - Istanbul, Turkey (Türkiye), 34722
    - Recruiting
    - T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  - Istanbul, Turkey (Türkiye), 34098
    - Not yet recruiting
    - Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi Hastanesi
  - Izmir, Turkey (Türkiye), 35575
    - Recruiting
    - Izmir Ekonomi Universitesi Medical Point Hastanesi
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Cambridge University Hospitals NHS Foundation Trust
  - London, United Kingdom, W6 8RF
    - Recruiting
    - Charing Cross Hospital
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Guy's Hospital
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Barts Health NHS Trust, St Bartholomew's Hospital
  - Manchester, United Kingdom, M20 4BX
    - Not yet recruiting
    - The Christie Nhs Foundation Trust
  - Manchester, United Kingdom, M20 4BX
    - Not yet recruiting
    - The Christie NHS Foundation Trust - Christie Hospital
  - Merseyside, United Kingdom, CH63 4JY
    - Recruiting
    - The Clatterbridge Cancer Centre NHS Foundation Trust, The Clatterbridge Cancer Centre - Wirral
- Scotland
  - Glasgow, Scotland, United Kingdom, G12 0YN
    - Recruiting
    - Beatson West Of Scotland Cancer Centre
United States
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Recruiting
    - Banner MD Anderson Cancer Center
    - Principal Investigator:
      
      Isaac Bowman
  - Gilbert, Arizona, United States, 85234
    - Recruiting
    - Banner Gateway Medical Center
- California
  - Anaheim, California, United States, 92806
    - Recruiting
    - Kaiser Permanente Anaheim Kraemer Medical Offices
  - Arcadia, California, United States, 91007
    - Recruiting
    - Foothill Cardioology
  - Baldwin Park, California, United States, 91706
    - Recruiting
    - Kaiser Permanente Baldwin Park Medical Center
  - Bellflower, California, United States, 90706
    - Recruiting
    - Kaiser Permanente Bellflower Medical Offices
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Beverly Hills Multi-Specialties Practice
  - Burbank, California, United States, 91505
    - Recruiting
    - Providence Saint Joseph Medical Center
  - Burbank, California, United States, 91505
    - Recruiting
    - UCLA Burbank Cardiology
  - Burbank, California, United States, 91505
    - Recruiting
    - UCLA Hematology/Oncology - Burbank
  - Duarte, California, United States, 91010
    - Active, not recruiting
    - City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
  - Encino, California, United States, 91436
    - Recruiting
    - UCLA Encino Specialty Care (Radiology)
  - Encino, California, United States, 91436
    - Recruiting
    - UCLA Hematology/Oncoclogy-Encino
  - Fontana, California, United States, 92335
    - Recruiting
    - Kaiser Permanente Fontana Medical Center
  - Glendora, California, United States, 91741
    - Recruiting
    - Foothill Cardiology Glendora
  - Harbor City, California, United States, 90710
    - Recruiting
    - Kaiser Permanente South Bay Medical center
  - Irvine, California, United States, 92612
    - Recruiting
    - Chao Family Comprehensive Cancer Center and Ambulatory Care
  - Irvine, California, United States, 92618
    - Recruiting
    - Kaiser Permanente Alton/Sand Canyon Medical Offices
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Hematology Oncology
  - Los Angeles, California, United States, 90067
    - Not yet recruiting
    - Valkyrie Clinical Trials
  - Los Angeles, California, United States, 90034
    - Recruiting
    - Kaiser Permanente West Los Angeles Medical Center
  - Los Angeles, California, United States, 90095
    - Recruiting
    - Ronald Reagan UCLA Medical Center, Drug Information Center
  - Los Angeles, California, United States, 90017
    - Recruiting
    - UCLA Downtown Los Angeles Primary & Specialty Care
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Cardiovascular Center
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Westwood Specialty Care
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente Los Angeles Medical Offices
  - Los Angeles, California, United States, 90404
    - Recruiting
    - UCLA Santa Monica Cardiology
  - Montecito, California, United States, 93108
    - Recruiting
    - UCLA Montecito Primary & Specialty Care
  - Newport Beach, California, United States, 92660
    - Recruiting
    - Newport Diagnostics Center (Radiology)
  - Ontario, California, United States, 91761
    - Recruiting
    - Kaiser Permanente Ontario Medical Center
  - Orange, California, United States, 92868
    - Recruiting
    - UC Irvine Health
  - Panorama City, California, United States, 91402
    - Recruiting
    - Kaiser Permanente Panorama City Medical Center, Medical Offices 3
  - Pasadena, California, United States, 91105
    - Recruiting
    - Southern California Heart Specialists
  - Pasadena, California, United States, 91105
    - Recruiting
    - Foothill Cardiology Pasadena
  - Pasadena, California, United States, 91105
    - Recruiting
    - UCLA Hematology/ Oncology- Pasadena
  - Porter Ranch, California, United States, 91326
    - Recruiting
    - UCLA Porter Ranch Primary & Specialty Care
  - Porter Ranch, California, United States, 91326
    - Recruiting
    - UCLA Hematology Oncology - Porter Ranch
  - Riverside, California, United States, 92505
    - Recruiting
    - Kaiser Permanente Riverside Medical Center
  - Riverside, California, United States, 92505
    - Recruiting
    - Southern California Permanente Medical Group (SCPMG)
  - San Diego, California, United States, 92120
    - Recruiting
    - Kaiser Permanente Zion Medical Center
  - San Diego, California, United States, 92108
    - Recruiting
    - Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)
  - San Francisco, California, United States, 94158
    - Recruiting
    - University of California, San Francisco
  - San Francisco, California, United States, 94158
    - Recruiting
    - UCSF Investigational Drugs Pharmacy
  - San Francisco, California, United States, 94158
    - Recruiting
    - University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
    - Principal Investigator:
      
      Vadim Koshkin
  - San Francisco, California, United States, 94115
    - Recruiting
    - UCSF Cancer Center MZ Phlebotomy
  - San Francisco, California, United States, 94115
    - Recruiting
    - UCSF Mount Zion Phlebotomy
  - San Francisco, California, United States, 94143
    - Recruiting
    - UCSF Parnassus Phlebotomy
  - San Gabriel, California, United States, 91776
    - Recruiting
    - Southern California Heart Centers
  - San Gabriel, California, United States, 91776
    - Recruiting
    - Diagnostic Medical Group of Southern California (Radiology)
  - San Luis Obispo, California, United States, 93401
    - Recruiting
    - UCLA Hematology/Oncology - San Luis Obispo
  - San Luis Obispo, California, United States, 93405
    - Recruiting
    - Sierra Vista Regional Medical Center
  - San Marcos, California, United States, 92078
    - Recruiting
    - Kaiser Permanente San Marcos Medical Offices
  - Santa Monica, California, United States, 90404
    - Recruiting
    - UCLA Hematology/Oncology - Santa Monica
  - Simi Valley, California, United States, 93065
    - Recruiting
    - UCLA Simi Valley Alamo Specialty Care
  - Templeton, California, United States, 93465
    - Recruiting
    - Twin Cities Community Hospital
  - Thousand Oaks, California, United States, 91360
    - Recruiting
    - UCLA Thousand Oaks Primary & Specialty Care
  - Torrance, California, United States, 90505
    - Recruiting
    - UCLA Hematology/Oncology - Torrance
  - Torrance, California, United States, 90505
    - Recruiting
    - UCLA Torrance Lomita Specialty Care
  - Valencia, California, United States, 91355
    - Recruiting
    - UCLA Santa Clarita Primary & Specialty Care
  - Valencia, California, United States, 91355
    - Recruiting
    - UCLA Hematology-Oncology Clinic - Santa Clarita
  - Ventura, California, United States, 93003
    - Recruiting
    - UCLA Ventura Cardiology
  - Ventura, California, United States, 93003
    - Recruiting
    - UCLA Hematology/Oncology - Ventura
  - Westlake Village, California, United States, 91361
    - Recruiting
    - UCLA Hematology/Oncology - Westlake
  - Woodland Hills, California, United States, 91367
    - Recruiting
    - Kaiser Permanente Woodland Hills Medical Center
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Not yet recruiting
    - Medstar Washington Hospital Center
- Florida
  - Bonita Springs, Florida, United States, 34135
    - Recruiting
    - Florida Cancer Specialists
  - Bradenton, Florida, United States, 34211
    - Recruiting
    - Florida Cancer Specialists
  - Bradenton, Florida, United States, 34205
    - Recruiting
    - Florida Cancer Specialists
  - Cape Coral, Florida, United States, 33909
    - Recruiting
    - Florida Cancer Specialists
  - Daytona Beach, Florida, United States, 32117
    - Active, not recruiting
    - Florida Cancer Specialists
  - Fleming Island, Florida, United States, 32003
    - Recruiting
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33908
    - Recruiting
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33905
    - Recruiting
    - Florida Cancer Specialists
  - N. Venice, Florida, United States, 34275
    - Recruiting
    - Florida Cancer Specialists
  - Naples, Florida, United States, 34102
    - Recruiting
    - Florida Cancer Specialists
  - Port Charlotte, Florida, United States, 33980
    - Recruiting
    - Florida Cancer Specialists
  - Sarasota, Florida, United States, 34232
    - Recruiting
    - Florida Cancer Specialists
  - Sarasota, Florida, United States, 34239
    - Recruiting
    - Florida Cancer Specialists Sarasota Memorial Hospital (SAD)
  - Stuart, Florida, United States, 34994
    - Active, not recruiting
    - Florida Cancer Specialists
  - Tallahassee, Florida, United States, 32308
    - Recruiting
    - Florida Cancer Specialists
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center McKinley Hospital
  - Venice, Florida, United States, 34292
    - Recruiting
    - Florida Cancer Specialists
  - Venice, Florida, United States, 34285
    - Recruiting
    - Florida Cancer Specialists
  - Vero Beach, Florida, United States, 32960
    - Active, not recruiting
    - Florida Cancer Specialists
  - Wellington, Florida, United States, 33414
    - Active, not recruiting
    - Florida Cancer Specialists
  - West Palm Beach, Florida, United States, 33401
    - Active, not recruiting
    - Florida Cancer Specialists
- Georgia
  - Carrollton, Georgia, United States, 30117
    - Active, not recruiting
    - Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
  - Carrollton, Georgia, United States, 30117
    - Active, not recruiting
    - West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
  - Cartersville, Georgia, United States, 30121
    - Active, not recruiting
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  - Douglasville, Georgia, United States, 30134
    - Active, not recruiting
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  - Hiram, Georgia, United States, 30141
    - Active, not recruiting
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  - Hiram, Georgia, United States, 30141
    - Active, not recruiting
    - WellStar Paulding Hospital
  - Marietta, Georgia, United States, 30060
    - Active, not recruiting
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - University of Chicago Medical Center
    - Principal Investigator:
      
      Peter H O'Donnell
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - UChicago Medicine - River East
  - Deerfield, Illinois, United States, 60015
    - Recruiting
    - Accellacare - Deerfield
  - Flossmoor, Illinois, United States, 60422
    - Recruiting
    - UChicago Medicine at Ingalls - Flossmoor
  - Harvey, Illinois, United States, 60426
    - Recruiting
    - UChicago Medicine Ingalls Memorial
  - New Lenox, Illinois, United States, 60451
    - Recruiting
    - University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  - Orland Park, Illinois, United States, 60462
    - Recruiting
    - The University of Chicago Medicine Center for Advanced Care Orland Park
  - Tinley Park, Illinois, United States, 60477
    - Recruiting
    - UChicago Medicine at Ingalls - Tinley Park
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - University of Massachusetts Chan Medical School
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - UMass Memorial Medical Center
- Michigan
  - Big Rapids, Michigan, United States, 49307
    - Recruiting
    - The Cancer & Hematology Centers
  - Detroit, Michigan, United States, 48201
    - Recruiting
    - Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Karmanos Cancer Institute Weisberg Cancer Treatment Center
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - The Cancer & Hematology Centers
  - Grand Rapids, Michigan, United States, 49546
    - Recruiting
    - Cancer & Hematology Centers of Western Michigan, PC- Kit Storage
  - Grand Rapids, Michigan, United States, 49546
    - Recruiting
    - The Cancer & Hematology Centers
  - Holland, Michigan, United States, 49424
    - Recruiting
    - The Cancer & Hematology Centers
  - Lansing, Michigan, United States, 48910
    - Recruiting
    - Karmanos Cancer Institute at McLaren Greater Lansing
  - Norton Shores, Michigan, United States, 49444
    - Recruiting
    - The Cancer & Hematology Centers
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Recruiting
    - MSK Basking Ridge
  - Middletown, New Jersey, United States, 07748
    - Recruiting
    - MSK Monmouth
  - Montvale, New Jersey, United States, 07645
    - Recruiting
    - MSK Bergen
- New York
  - Commack, New York, United States, 11725
    - Recruiting
    - MSK Commack
  - Harrison, New York, United States, 10604
    - Recruiting
    - MSK Wesrchester
  - Lake Success, New York, United States, 11042
    - Active, not recruiting
    - Northwell Health
  - Long Island City, New York, United States, 11101
    - Recruiting
    - Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, United States, 10065
    - Recruiting
    - Memorial Sloan Kettering Cancer Center - Main Campus
  - New York, New York, United States, 10021
    - Recruiting
    - Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
  - New York, New York, United States, 10065
    - Recruiting
    - Evelyn H. Lauder Breast and Imaging Centre (BAIC)
  - New York, New York, United States, 10065
    - Recruiting
    - Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
  - Syracuse, New York, United States, 13210
    - Active, not recruiting
    - SUNY Upstate Medical University
  - Uniondale, New York, United States, 11553
    - Recruiting
    - MSK Nassau
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Not yet recruiting
    - UNC Hospitals, The University of North Carolina at Chapel Hill
  - Chapel Hill, North Carolina, United States, 27599
    - Not yet recruiting
    - UNC Lineberger Comprehensive Cancer Center / University of North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Levine Cancer Institute
    - Principal Investigator:
      
      Earle Burgess
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Carolinas Medical Center Investigational Drug Services
  - Charlotte, North Carolina, United States, 28203
    - Recruiting
    - Carolinas Medical Center (biopsy only)
  - Charlotte, North Carolina, United States, 28207
    - Recruiting
    - Atrium Health Mercy (biopsy only)
  - Charlotte, North Carolina, United States, 28262
    - Recruiting
    - Atrium Health University City (biopsy only)
  - Charlotte, North Carolina, United States, 28262
    - Recruiting
    - Levine Cancer Institute University
  - Charlotte, North Carolina, United States, 28277
    - Recruiting
    - Levine Cancer Institute - Ballantyne
  - Concord, North Carolina, United States, 28025
    - Recruiting
    - Atrium Health Cabarrus (biopsy only)
  - Concord, North Carolina, United States, 28025
    - Recruiting
    - Levine Cancer Institute Concord
  - Gastonia, North Carolina, United States, 28054
    - Recruiting
    - Levine Cancer Institute- Gaston
  - Monroe, North Carolina, United States, 28112
    - Recruiting
    - Atrium Health Union (biopsy only)
- Ohio
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals Cleveland Medical Center
    - Principal Investigator:
      
      Jason Robert Brown
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Ohio State University
    - Principal Investigator:
      
      Peng Wang
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Ohio State University Hospital
  - Columbus, Ohio, United States, 43221
    - Recruiting
    - The James Outpatient Care West Campus
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - OSU Wexner Medical Center & James Cancer Hospital
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - OSU Wexner Medical Center, Investigational Drug Services
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The James Cancer Hospital & Solove Research Institute at The OSU Comprehensive Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - OU Health Stephenson Cancer Center
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - OU Medical Center
- Tennessee
  - Knoxville, Tennessee, United States, 37920
    - Recruiting
    - University of Tennessee Medical Center
- Texas
  - Dallas, Texas, United States, 75204
    - Not yet recruiting
    - Baylor Scott and White Research Institute
  - Houston, Texas, United States, 77030
    - Recruiting
    - The University of Texas MD Anderson Cancer Center
  - Temple, Texas, United States, 76508
    - Not yet recruiting
    - Baylor Scott & White Medical Center - Temple
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Inova Schar Cancer Institute
    - Principal Investigator:
      
      Jeanny B Aragon-Ching, MD, F.A.C.P.
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98109
    - Recruiting
    - Fred Hutchinson Cancer Center
  - Seattle, Washington, United States, 98104
    - Recruiting
    - Harborview Medical Center
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Froedtert Hospital/Medical College of Wisconsin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Cohorts A and B

Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
At least one measurable lesion by investigator assessment based on RECIST version 1.1.
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Cohort C

Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
No prior systemic therapy for LA/mUC
- Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy
At least one measurable lesion by investigator assessment based on RECIST v1.1.
Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample
ECOG performance status of 0, 1, or 2

Cohort D

Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:
- a. One prior line of platinum-containing chemotherapy.
- b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.
- c. Prior enfortumab vedotin therapy.
At least one measurable lesion by investigator assessment based on RECIST v1.1.
ECOG performance status of 0 or 1

Cohort E

Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
No prior systemic therapy for LA/mUC
- Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.
At least one measurable lesion by investigator assessment based on RECIST v1.1.
Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
ECOG performance status of 0 or 1

Cohort G

Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab
- The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin.
At least one measurable lesion by investigator assessment based on RECIST version 1.1.
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

Cohorts A and B

Known hypersensitivity to disitamab vedotin or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

Cohort C

Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Participants who have previously received any 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) are excluded.

Cohort D

Known hypersensitivity to disitamab vedotin or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Prior HER2-directed therapy
Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline

Cohort E

Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug

Cohort G

Known hypersensitivity to disitamab vedotin or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Prior HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

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: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A - DV monotherapy for HER2-positive tumor types Disitamab vedotin monotherapy	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC
Experimental: Cohort B - DV monotherapy for HER2-low tumor types Disitamab vedotin monotherapy	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC
Experimental: Cohort C - Non-randomized combination therapy Disitamab vedotin + pembrolizumab	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC Drug: pembrolizumab Given by IV on Day 1 of each 6-week cycle. Other Names: KEYTRUDA®
Experimental: Cohort C - Randomized combination therapy Disitamab vedotin + pembrolizumab	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC Drug: pembrolizumab Given by IV on Day 1 of each 6-week cycle. Other Names: KEYTRUDA®
Experimental: Cohort C - Randomized monotherapy Disitamab vedotin monotherapy	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC
Experimental: Cohort D - DV monotherapy (Japan only) Disitamab vedotin monotherapy	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC
Experimental: Cohort E - DV combination therapy (Japan only) Disitamab vedotin + pembrolizumab	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC Drug: pembrolizumab Given by IV on Day 1 of each 6-week cycle. Other Names: KEYTRUDA®
Experimental: Cohort G - DV monotherapy Disitamab vedotin	Drug: disitamab vedotin Given into the vein (IV; intravenous) every 2 weeks. Other Names: RC48-ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) (Cohorts D and E) Time Frame: Approximately 2 years	Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	Approximately 2 years
Incidence of dose alterations (Cohorts D and E) Time Frame: Approximately 2 years		Approximately 2 years
Incidence of laboratory abnormalities (Cohorts D and E) Time Frame: Approximately 2 years	To be summarized using descriptive statistics.	Approximately 2 years
Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E) Time Frame: Approximately 2 years		Approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E) Time Frame: Approximately 2 years		Approximately 2 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Maximum concentration (Cmax) (Cohorts D and E) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Trough concentration (Ctrough) (Cohorts D and E) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G) Time Frame: Duration of treatment; approximately 2 years	The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1	Duration of treatment; approximately 2 years

Secondary Outcome Measures

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

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)

May 3, 2022

Primary Completion (Estimated)

December 11, 2026

Study Completion (Estimated)

April 14, 2029

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RC48G001
C5731002 (Other Identifier: Alias Study Number)
2022-500030-28-01 (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.

Clinical Trials on Urothelial Carcinoma

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Active, not recruiting

Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy (IMAGINE)

Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditions

United States
University of Utah
National Cancer Institute (NCI)

Active, not recruiting

Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma (RESOLVE)

Metastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Urothelial Carcinoma, Sarcomatoid Variant

United States
National Cancer Institute (NCI)

Active, not recruiting

Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction

Metastatic Urothelial Carcinoma | Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 | Stage IV Bladder Urothelial Carcinoma AJCC v7 | Locally Advanced Urothelial Carcinoma | Recurrent Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Advanced Urothelial Carcinoma

United States
Roswell Park Cancer Institute
Iovance Biotherapeutics, Inc.

Withdrawn

Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy

Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial Carcinoma

United States
Pfizer

Completed

A Real-world Study of the First Treatment and Outcomes of Patients With Advanced or Metastatic Bladder Cancer

Urothelial Carcinoma | Urothelial Cancer | Metastatic Urothelial Carcinoma | Locally Advanced or Metastatic Urothelial Carcinoma

United States
Mamta Parikh
National Cancer Institute (NCI); Karyopharm Therapeutics Inc

Terminated

Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma

Metastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial Carcinoma

United States
National Cancer Institute (NCI)

Recruiting

A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer

Metastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Pemetrexed and Avelumab in Treating Patients With MTAP-Deficient Metastatic Urothelial Cancer

Metastatic Urothelial Carcinoma | Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant | Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant | Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation | Infiltrating Bladder Urothelial Carcinoma With Squamous... and other conditions

United States
Vadim S Koshkin
ImmunityBio, Inc.

Withdrawn

N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer

Urothelial Carcinoma | Urothelial Cancer | Metastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma

United States
Emory University
National Cancer Institute (NCI); Exelixis

Recruiting

Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

Metastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation

United States

Clinical Trials on disitamab vedotin

RenJi Hospital

Not yet recruiting

HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC (HERO-UTUC)

Upper Urinary Tract Urothelial Carcinoma

China
RenJi Hospital

Recruiting

RC48-ADC in HER2-low Advanced Breast Cancer

Advanced Breast Cancer

China
Tianjin Medical University Second Hospital

Recruiting

Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

China
Sun Yat-sen University
RemeGen Co., Ltd.; Shanghai Kechow Pharma, Inc.; BeOne Medicines

Not yet recruiting

A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer (DTP-HER2)

Gastric Adenocarcinoma

China
West China Hospital
Chengdu First People's Hospital; Jiangsu Taizhou People's Hospital

Not yet recruiting

A Real-World, Single-Arm Study Protocol of Disitamab Vedotin in Combination With Immunotherapy and Multimodal Radiation Therapy for HER2-Positive Advanced Gastric Cancer: After Second-Line Treatment Failure

HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Peking Union Medical College Hospital

Not yet recruiting

Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

Biliary Tract Cancer | Immune Checkpoint Inhibitors | Lenvatinib | Disitamab Vedotin

China
RemeGen Co., Ltd.

Recruiting

A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer

Cervical Cancer

China
West China Hospital

Not yet recruiting

Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer

Breast Cancer

China
Wuhan Union Hospital, China

Recruiting

The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

Breast Cancer | Neoadjuvant Therapy

China
The Affiliated Nanjing Drum Tower Hospital of Nanjing...

Not yet recruiting

A Clinical Study of RC48-ADC Combined With Triplizumab For Treatment of Myometrial Invasive Bladder Cancer

Bladder Cancer

China

Outcome Measure	Measure Description	Time Frame
PK parameter of pembrolizumab - Cmax (Cohort E) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin (All Cohorts) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) against pembrolizumab (Cohorts C and E) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
Incidence of neutralizing antibodies (NABs) against disitamab vedotin (All Cohorts) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
cORR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G) Time Frame: Duration of treatment; approximately 2 years	The proportion of participants with confirmed CR or PR according to RECIST v1.1	Duration of treatment; approximately 2 years
Confirmed Duration of Response (DOR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G) Time Frame: From start of treatment to completion of response assessment; approximately 2 years	The time from first documentation of objective tumor response (confirmed CR or PR) to the first documentation of tumor progression per RECIST v1.1 or death due to any cause.	From start of treatment to completion of response assessment; approximately 2 years
Confirmed DOR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G) Time Frame: From start of treatment to completion of response assessment; approximately 2 years	The time from first documentation of objective tumor response (confirmed CR or PR) to the first documentation of tumor progression per RECIST v1.1 or death due to any cause.	From start of treatment to completion of response assessment; approximately 2 years
Progression-free survival (PFS) per RECIST v1.1 by BICR (Cohorts A, B, C, and G) Time Frame: From start of treatment to completion of response assessment; approximately 2 years	The time from the start of study treatment or randomization (if applicable) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.	From start of treatment to completion of response assessment; approximately 2 years
PFS per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G) Time Frame: From start of treatment to completion of response assessment; approximately 2 years	The time from the start of study treatment or randomization (if applicable) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.	From start of treatment to completion of response assessment; approximately 2 years
Disease control rate (DCR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G) Time Frame: From start of treatment to completion of response assessment; approximately 2 years	The proportion of participants who have achieved objective response (confirmed CR or PR as per RECIST v1.1 criteria) or stable disease (SD) lasting at least 5 weeks.	From start of treatment to completion of response assessment; approximately 2 years
DCR per RECIST v1.1 by investigator (Cohorts A, B, C, and G) Time Frame: From start of treatment to completion of response assessment; approximately 2 years	The proportion of participants who have achieved objective response (confirmed CR or PR as per RECIST v 1.1 criteria) or SD lasting at least 5 weeks.	From start of treatment to completion of response assessment; approximately 2 years
Overall survival (OS) (Cohorts A, B, C, and G) Time Frame: Duration of study; approximately 3 years	The time from start of study treatment or randomization (if applicable) to the date of death due to any cause.	Duration of study; approximately 3 years
Incidence of adverse events (AEs) (Cohorts A, B, C, and G) Time Frame: Approximately 2 years	Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	Approximately 2 years
Incidence of dose alterations (Cohorts A, B, C, and G) Time Frame: Approximately 2 years	To be summarized using descriptive statistics.	Approximately 2 years
Incidence of laboratory abnormalities (Cohorts A, B, C, and G) Time Frame: Approximately 2 years	To be summarized using descriptive statistics.	Approximately 2 years
Incidence of ECG abnormalities (Cohorts A, B, C, and G) Time Frame: Approximately 2 years		Approximately 2 years
Change from baseline of LVEF (Cohorts A, B, C, and G) Time Frame: Approximately 2 years		Approximately 2 years
PK parameter - AUC (Cohorts A, B, C, and G) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Cmax (Cohorts A, B, C, and G) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Tmax (Cohorts A, B, C, and G) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Ctrough (Cohorts A, B, C, and G) Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years	To be summarized using descriptive statistics.	Through 30-37 days following the last dose of DV; up to approximately 2 years

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations