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

NCT ID: NCT05911295

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2029-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Disitamab vedotin arm

disitamab vedotin + pembrolizumab

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

400mg given by IV every 6 weeks

Standard of care arm

gemcitabine + cisplatin OR carboplatin

Group Type ACTIVE_COMPARATOR

gemcitabine

Intervention Type DRUG

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

cisplatin

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

Interventions

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disitamab vedotin

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

Intervention Type DRUG

pembrolizumab

400mg given by IV every 6 weeks

Intervention Type DRUG

gemcitabine

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

Intervention Type DRUG

cisplatin

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

Intervention Type DRUG

carboplatin

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

Intervention Type DRUG

Other Intervention Names

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RC48, RC48-ADC KEYTRUDA® Gemzar

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
* History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.
* Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.

* CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
* Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.
* History of or active autoimmune disease that has required systemic treatment in the past 2 years.
* Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).
* Prior solid organ or bone marrow transplantation.
* Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
* Estimated life expectancy \<12 week
* Prior treatment with an MMAE agent or anti-HER2 therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RemeGen Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Banner Gateway Medical Center

Gilbert, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

UCLA Hematology/Oncology - Alhambra

Alhambra, California, United States

Site Status RECRUITING

Foothill Cardioology

Arcadia, California, United States

Site Status RECRUITING

Beverly Hills Multi-Specialties Practice

Beverly Hills, California, United States

Site Status RECRUITING

Providence Saint Joseph Medical Center

Burbank, California, United States

Site Status RECRUITING

UCLA Burbank Cardiology

Burbank, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Burbank

Burbank, California, United States

Site Status RECRUITING

UCLA Calabasas Specialty Care

Calabasas, California, United States

Site Status RECRUITING

UCLA Encino Specialty Care (Radiology)

Encino, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Encino

Encino, California, United States

Site Status RECRUITING

Helios Clinical Research

Fountain Valley, California, United States

Site Status RECRUITING

Helios Clinical Research

Glendale, California, United States

Site Status RECRUITING

Foothill Cardiology Glendora

Glendora, California, United States

Site Status RECRUITING

Helios Clinical Research

Long Beach, California, United States

Site Status RECRUITING

UCLA Downtown Los Angeles Primary & Specialty Care

Los Angeles, California, United States

Site Status RECRUITING

UCLA Cardiovascular Center

Los Angeles, California, United States

Site Status RECRUITING

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, United States

Site Status RECRUITING

UCLA Hematology & Oncology Clinic

Los Angeles, California, United States

Site Status RECRUITING

UCLA Hematology / Oncology

Los Angeles, California, United States

Site Status RECRUITING

UCLA Westwood Specialty Care

Los Angeles, California, United States

Site Status RECRUITING

UCLA Montecito Primary & Specialty Care

Montecito, California, United States

Site Status RECRUITING

Pacific Cancer Care

Monterey, California, United States

Site Status ACTIVE_NOT_RECRUITING

Newport Diagnostics

Newport Beach, California, United States

Site Status RECRUITING

Foothill Cardiology Pasadena

Pasadena, California, United States

Site Status RECRUITING

Southern California Heart Specialists

Pasadena, California, United States

Site Status RECRUITING

UCLA Porter Ranch Primary & Specialty Care

Porter Ranch, California, United States

Site Status RECRUITING

UCSF Center at China Basin Imaging

San Francisco, California, United States

Site Status RECRUITING

Helen Diller Family Comprehensive Cancer Center - Imaging Divisadero

San Francisco, California, United States

Site Status RECRUITING

Helen Diller Family Comprehensive Cancer Center - Imaging Post

San Francisco, California, United States

Site Status RECRUITING

UCSF Cancer Center MZ Phlebotomy

San Francisco, California, United States

Site Status RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status RECRUITING

UCSF Mount Zion Phlebotomy

San Francisco, California, United States

Site Status RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status RECRUITING

UCSF Parnassus Phlebotomy

San Francisco, California, United States

Site Status RECRUITING

UCSF Parnassus-5 Lab

San Francisco, California, United States

Site Status RECRUITING

Cardiovascular Care and Prevention Center at Mission Bay

San Francisco, California, United States

Site Status RECRUITING

The Regents of the University of California

San Francisco, California, United States

Site Status RECRUITING

UCSF Investigational Drugs Pharmacy

San Francisco, California, United States

Site Status RECRUITING

UCSF Mission Bay Gateway-2 Lab

San Francisco, California, United States

Site Status RECRUITING

UCSF Mission Bay PCMB-5 Lab

San Francisco, California, United States

Site Status RECRUITING

UCSF Mission Bay Pediatric Clinical Research Center

San Francisco, California, United States

Site Status RECRUITING

UCSF Mission Bay Radiology and Nuclear Medicine

San Francisco, California, United States

Site Status RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

University of California, San Francisco | HDFCCC - Hematopoietic malignancies

San Francisco, California, United States

Site Status RECRUITING

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

San Gabriel, California, United States

Site Status RECRUITING

Southern California Heart Centers

San Gabriel, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - San Luis Obispo

San Luis Obispo, California, United States

Site Status RECRUITING

Sierra Vista Regional Medical Center

San Luis Obispo, California, United States

Site Status RECRUITING

Helios Clinical Research

Santa Ana, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Santa Barbara

Santa Barbara, California, United States

Site Status RECRUITING

UCLA Santa Monica Cardiology

Santa Monica, California, United States

Site Status RECRUITING

UCLA Simi Valley Alamo Specialty Care

Simi Valley, California, United States

Site Status RECRUITING

Twin Cities Community Hospital

Templeton, California, United States

Site Status RECRUITING

UCLA Thousand Oaks Primary & Specialty Care

Thousand Oaks, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Torrance

Torrance, California, United States

Site Status RECRUITING

UCLA Torrance Lomita Specialty Care

Torrance, California, United States

Site Status RECRUITING

UCLA Santa Clarita Primary & Specialty Care

Valencia, California, United States

Site Status RECRUITING

UCLA Ventura Cardiology

Ventura, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Westlake

Westlake Village, California, United States

Site Status RECRUITING

Helios Clinical Research

Whittier, California, United States

Site Status RECRUITING

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

HealthPartners Institute

Bloomington, Minnesota, United States

Site Status RECRUITING

M Health Fairview Ridges Cancer Clinic

Burnsville, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology, PA

Burnsville, Minnesota, United States

Site Status RECRUITING

Allina Health Cancer Institute

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology, PA

Coon Rapids, Minnesota, United States

Site Status RECRUITING

M Health Fairview Cancer Clinic-Edina

Edina, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology Pa

Edina, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology, PA

Fridley, Minnesota, United States

Site Status RECRUITING

M Health Fairview Maple Grove Cancer Center

Maple Grove, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology, PA

Maplewood, Minnesota, United States

Site Status RECRUITING

Allina Health Cancer Institute-United(VPCI)

Minneapolis, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, United States

Site Status RECRUITING

Hennepin Country Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

M Health Fairview University of Minnesota Investigational Drug Services

Minneapolis, Minnesota, United States

Site Status RECRUITING

Metro Minnesota Community Oncology Research Consortium(MMCORC)

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Allina Health Cancer Institute-United(VPCI)

Saint Paul, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology, PA

Woodbury, Minnesota, United States

Site Status RECRUITING

M Health Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status RECRUITING

Nebraska Medicine- Bellevue Medical Center

Bellevue, Nebraska, United States

Site Status RECRUITING

Nebraska Medicine -Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Nebraska Medicine-Cancer Center at Village Pointe Health Center

Omaha, Nebraska, United States

Site Status RECRUITING

The University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Optum Care Cancer Care at Seven Hills

Las Vegas, Nevada, United States

Site Status RECRUITING

OptumCare Cancer center

Las Vegas, Nevada, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Ship study drug to: Mount Sinai Hospital- Pharmacy Dept

New York, New York, United States

Site Status RECRUITING

ECU Health Medical Center

Greenville, North Carolina, United States

Site Status RECRUITING

AHN Saint Vincent Hospital

Erie, Pennsylvania, United States

Site Status RECRUITING

AHN Jefferson Hospital

Jefferson Hills, Pennsylvania, United States

Site Status RECRUITING

AHN Forbes Hospital

Monroeville, Pennsylvania, United States

Site Status RECRUITING

Allegheny Valley Hospital

Natrona Heights, Pennsylvania, United States

Site Status RECRUITING

AHN Cancer Institute - Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

AHN Cancer Institute Pharmacy

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

AHN West Penn Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern Medical Center - Redbird

Dallas, Texas, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy

Dallas, Texas, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern - Simmons Cancer Center - Fort Worth

Fort Worth, Texas, United States

Site Status RECRUITING

UT Southwestern - Simmons Cancer Center - Richardson/Plano

Richardson, Texas, United States

Site Status RECRUITING

Inova Schar Cancer Institue Infusion Pharmacy

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status RECRUITING

Harborview Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center.

Seattle, Washington, United States

Site Status RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Centro de Investigacion Pergamino SA

Pergamino, Buenos Aires, Argentina

Site Status RECRUITING

Centro de Investigaciones Medicas y Desarrollo LC

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Clinica Viedma

Viedma, Río Negro Province, Argentina

Site Status RECRUITING

Fundación Dr. Ruben Kowalyszyn

Viedma, Río Negro Province, Argentina

Site Status RECRUITING

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Centro de Oncologia e Investigacion de Buenos Aires (COIBA)

Berazategui, , Argentina

Site Status RECRUITING

Labmedicina

Buenos Aires, , Argentina

Site Status RECRUITING

Fundacion CENIT para la lnvestigacion en Neurociencias

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto Médico Especializado Alexander Fleming

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Oncologico Korben

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Medico Austral

Buenos Aire, , Argentina

Site Status RECRUITING

Centro Oncologico Korben

Buenos Aire, , Argentina

Site Status RECRUITING

Fundacion Cenit

CABA, , Argentina

Site Status RECRUITING

Investigaciones Clinicas Moleculares (ICM)

CABA, , Argentina

Site Status RECRUITING

Clínica Universitaria Reina Fabiola

Córdoba, , Argentina

Site Status RECRUITING

CEMAIC - Centro Medico Privado

Córdoba, , Argentina

Site Status RECRUITING

Hospital Municipal de Morón. O. B. Lavignolle

Morón, , Argentina

Site Status NOT_YET_RECRUITING

Comité Provincial de Bioética-Rosario

Rosario, , Argentina

Site Status RECRUITING

Grupo de Investigación en Oncología Clínica del Santario Parque

Rosario, , Argentina

Site Status RECRUITING

Consultorio Dr. Miguel Angel Escudero

Salta, , Argentina

Site Status RECRUITING

Oncologia Salta

Salta, , Argentina

Site Status RECRUITING

Centro para la Atencion Integral del paciente Oncologico

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status RECRUITING

Saint Vincents Hospital Sydney - Human Research Ethics Committee

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

St Vincent's Clinic

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

St George Hospital

Kogarah, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Macquarie University Hospital

Macquarie University, New South Wales, Australia

Site Status RECRUITING

Macquarie University

North Ryde, New South Wales, Australia

Site Status RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status RECRUITING

North Shore Private Hospital

St Leonards, New South Wales, Australia

Site Status RECRUITING

Mater Misericordiae - Mater Hospital Brisbane

Brisbane, Queensland, Australia

Site Status RECRUITING

ICON Cancer Centre Chermside

Chermside, Queensland, Australia

Site Status RECRUITING

Icon Cancer Centre Chermside

Herston, Queensland, Australia

Site Status RECRUITING

Mater Research

South Bribane, Queensland, Australia

Site Status RECRUITING

Peninsula & South Eastern Hematology and Oncology Group (PASO)

Frankston, Victoria, Australia

Site Status RECRUITING

Cabrini Hospital

Malvern, Victoria, Australia

Site Status RECRUITING

Austin Health

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

South Eastern Sydney Local Health District

Caringbah, , Australia

Site Status RECRUITING

Lyell McEwin Hospital

Elizabeth Vale, , Australia

Site Status RECRUITING

Peninsula And South East Oncology

Frankston, , Australia

Site Status RECRUITING

Mid North Coast Local Health District

NSW, , Australia

Site Status RECRUITING

Port Macquarie Base Hospital

Port Macquarie, , Australia

Site Status RECRUITING

Royal North Shore Hospital

St Leonards, , Australia

Site Status RECRUITING

Algemeen Ziekenhuis Maria Middelares

Ghent, , Belgium

Site Status RECRUITING

AZ St. Lucas

Ghent, , Belgium

Site Status RECRUITING

University Hospital Ghent

Ghent, , Belgium

Site Status RECRUITING

CHU de Liege Service Oncologie Medicale

Liège, , Belgium

Site Status NOT_YET_RECRUITING

CHU UCL Namur-Site de Saint Elisabeth

Namur, , Belgium

Site Status NOT_YET_RECRUITING

Suporte Nutricional e Quimioterapia - PRONUTRIR

Fortaleza, Ceará, Brazil

Site Status RECRUITING

Centro de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Centro de Oncologia Hospital Sírio Libanês

Brasília, Federal District, Brazil

Site Status NOT_YET_RECRUITING

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

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Nossa Senhora da Conceicao / Grupo Hospitalar Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Fundacao Doutor Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status RECRUITING

Instituto de Ensino e Pesquisa - Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos, , Brazil

Site Status RECRUITING

Erasto Gaertner Hospital

CuriBba, , Brazil

Site Status RECRUITING

Instituto Nacional De Cancer - INCA

Rio de Janeiro, , Brazil

Site Status RECRUITING

Instituto Nacional De Cancer - INCA

Rio de Janeiro, , Brazil

Site Status RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

Site Status RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta / Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

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

Oshawa, Ontario, Canada

Site Status RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Centro de Oncologia de Precision

Los Condes, Region Metropolitana Santiago, Chile

Site Status RECRUITING

Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Oncovida - Santiago

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Cesfar

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Centro de Investigacion Clinica Bradford Hill

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Centro de Estudios Clínicos SAGA

Santiago, , Chile

Site Status RECRUITING

Centro de Investigaciones Clinicas Vina del Mar

Viña del Mar, , Chile

Site Status RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, Czechia

Site Status RECRUITING

Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

Olomouc, , Czechia

Site Status RECRUITING

Centre Paul Strauss

Starsbourg, Grand Est, France

Site Status TERMINATED

Hospices Civils de Lyon - Hopitale Lyon Sud

Pierre-Bénite, Rhône, France

Site Status RECRUITING

University Hospital of Besancon

Besançon, , France

Site Status NOT_YET_RECRUITING

Institut Bergonié Centre de Lutte Contre le Cancer (CLCC)

Bordeaux, , France

Site Status RECRUITING

Polyclinique de Limoges Site Chenieux

Limoges, , France

Site Status NOT_YET_RECRUITING

Unite de Coordination de la Biologie des Essais Cliniques

Strasbourg, , France

Site Status TERMINATED

Institut de Cancerologie Strasbourg Europe

Strasbourg, , France

Site Status TERMINATED

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Athens Medical Center

Marousi, Attikí, Greece

Site Status RECRUITING

Bioclinic Thessalonikis Private Clinic Single Member S.A.

Thessaloniki, Kentrikí Makedonía, Greece

Site Status RECRUITING

Metropolitan General Hospital

Cholargós, , Greece

Site Status RECRUITING

Semmelweis Egyetem Urologiai Klinika

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Országos Onkológiai Intézet

Budapest, , Hungary

Site Status RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, , Hungary

Site Status RECRUITING

Cancer Trials Cork

Cork, , Ireland

Site Status NOT_YET_RECRUITING

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status NOT_YET_RECRUITING

Beaumont Hospital

Dublin, , Ireland

Site Status NOT_YET_RECRUITING

Tallaght University Hospital

Tallaght, , Ireland

Site Status NOT_YET_RECRUITING

Cork University Hospital

Wilton, , Ireland

Site Status NOT_YET_RECRUITING

Shaare Zedek Medical Center

Jerusalem, Other, Israel

Site Status ACTIVE_NOT_RECRUITING

Sheba Medical Center.

Ramat Gan, Other, Israel

Site Status ACTIVE_NOT_RECRUITING

Emek Medical Center

Afula, , Israel

Site Status RECRUITING

Soroka Medical Center

Beersheba, , Israel

Site Status ACTIVE_NOT_RECRUITING

Rambam Health Care Campus

Hafia, , Israel

Site Status ACTIVE_NOT_RECRUITING

Hadassah University Hospital at Ein Kerem

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Meir Medical Center

Kefar Sava, , Israel

Site Status ACTIVE_NOT_RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status ACTIVE_NOT_RECRUITING

IRCCS Istituto Tumori Giovanni Paolo II

Bari, Apulia, Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, Apulia, Italy

Site Status RECRUITING

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

Meldola (Fc), Emilia-Romagna, Italy

Site Status NOT_YET_RECRUITING

Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status RECRUITING

IRCCS San Raffaele Hospital ,Genitourinary medical Oncology

Lombardy, Milan, Italy

Site Status RECRUITING

Azienda Sanitaria Locale Napoli 2 Nord

Giugliano in Campania, Naples, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, Other, Italy

Site Status RECRUITING

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

Pozzuoli (NA), Other, Italy

Site Status RECRUITING

SOSD Farmacia Ospedaliera

Aviano, Pordenone, Italy

Site Status RECRUITING

Centro di Riferimento Oncologico Di Aviano

Aviano, Pordenone, Italy

Site Status RECRUITING

AUSL Romagna - Presidio Ospedale "Umberto I" di Lugo

Lugo, Ravenna, Italy

Site Status RECRUITING

AUSL della Romagna - Ospedale degli infermi

Faenza, RA, Italy

Site Status RECRUITING

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, ROMA, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Careggi-SODc Oncologia Clinica (Padiglione16)

Florence, Tuscany, Italy

Site Status RECRUITING

ASST Cremona Farmacia Ospedaliera

Cremona, , Italy

Site Status RECRUITING

U.O. Farmacia Ospedaliera a Politiche del Farmaco Az. Osp. Universitaria Careggi

Florence, , Italy

Site Status RECRUITING

Ospedale Policlinico San Martino Farmacia

Genova, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G.Pascale Napoli Pascale

Napoli, , Italy

Site Status NOT_YET_RECRUITING

SC Farmacia Ospedaliera C/O Istituto Nazionale Tumori IRCCS Fondazione G.Pascale Napoli Pascale

Napoli, , Italy

Site Status NOT_YET_RECRUITING

Istituto Oncologico Veneto - IRCCS

Padua, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

Pisa, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Pisana, U.O. Farmacia Ospedaliera

Pisa, , Italy

Site Status RECRUITING

Unita Operative di Oncologia,Ospedale S.Maria delle Croci

Ravenna, , Italy

Site Status RECRUITING

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

Terni, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , Italy

Site Status RECRUITING

Centro Ricerche Cliniche Di Verona Srl

Verona, , Italy

Site Status RECRUITING

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Site Status NOT_YET_RECRUITING

Ehime University Hospital

Tōon, Ehime, Japan

Site Status NOT_YET_RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Gunma Prefectural Cancer Center

Ota-Shi, Gunma, Japan

Site Status NOT_YET_RECRUITING

Kobe University Hospital

Kobe, Hyōgo, Japan

Site Status RECRUITING

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Site Status NOT_YET_RECRUITING

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Site Status RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Site Status NOT_YET_RECRUITING

Nara Medical University Hospital

Kashihara, Nara, Japan

Site Status NOT_YET_RECRUITING

Kindai University Hospital

Osakasayama-Shi, Osaka, Japan

Site Status NOT_YET_RECRUITING

Osaka University Hopsital

Suita, Osaka, Japan

Site Status NOT_YET_RECRUITING

Tokushima University Hospital

Tokushima, Tokushima, Japan

Site Status RECRUITING

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status NOT_YET_RECRUITING

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Site Status RECRUITING

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Site Status NOT_YET_RECRUITING

Chiba Cancer Center

Chiba, , Japan

Site Status NOT_YET_RECRUITING

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

Site Status RECRUITING

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, , Japan

Site Status NOT_YET_RECRUITING

Yamagata University Hospital

Yamagata, , Japan

Site Status NOT_YET_RECRUITING

Antoni van Leeuwenhoek Apotheek,I-2

Amsterdam, , Netherlands

Site Status RECRUITING

Netherlands Cancer Institute/Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Site Status RECRUITING

Rijnstate Hospital

Arnhem, , Netherlands

Site Status RECRUITING

Amphia Ziekenhuis

Breda, , Netherlands

Site Status RECRUITING

Maastricht Universitair Medisch Centrum+

Maastricht, , Netherlands

Site Status NOT_YET_RECRUITING

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status RECRUITING

Stichting HagaZiekenhuis

The Hague, , Netherlands

Site Status RECRUITING

Hospital Militar Central Coronel Luis Arias Schreiber

Lima, , Peru

Site Status RECRUITING

Hospital Maria Auxiliadora

Lima, , Peru

Site Status RECRUITING

Hospital de Braga

Sao Victor, Braga District, Portugal

Site Status RECRUITING

Hospital de Braga

Braga, , Portugal

Site Status RECRUITING

Centro Clinico Champalimaud

Lisbon, , Portugal

Site Status RECRUITING

Champalimaud Clinical Center

Lisbon, , Portugal

Site Status RECRUITING

Hospital de Santa Maria - Centro Hospitalar Universitario Lisboa Norte

Lisbon, , Portugal

Site Status RECRUITING

Centro Hospitalar Universitário de São João

Porto, , Portugal

Site Status RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Raffles Hospital

Singapore, , Singapore

Site Status RECRUITING

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

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

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Site Status RECRUITING

Wonkwang University Hospital

Iksan-si, Jeonlabuk-do, South Korea

Site Status RECRUITING

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status RECRUITING

Kosin University Gospel Hospital

Busan, , South Korea

Site Status NOT_YET_RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center - Oncology

Seoul, , South Korea

Site Status RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruna, Spain

Site Status NOT_YET_RECRUITING

Farmacia Oncologica - Unidad de Ensayos Clinicos

Santiago de Compostela, A Coruna, Spain

Site Status NOT_YET_RECRUITING

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

Badalona, Barcelona, Spain

Site Status RECRUITING

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

Badalona, Barcelona, Spain

Site Status RECRUITING

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

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital de Cruzes

Barakaldo, Bizkaia, Spain

Site Status RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Site Status RECRUITING

HUB-Hospital Universitario Badajoz

Badajoz, , Spain

Site Status RECRUITING

Infanta Cristina Hospital

Badajoz, , Spain

Site Status RECRUITING

Hospital Del Mar

Barcelona, , Spain

Site Status RECRUITING

ASCIRES CETIR Viladomat

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau- Pharmacy

Barcelona, , Spain

Site Status RECRUITING

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Unitat d'Assajos Clinics Servei de Farmacia

L'Hospitaler de Llobregat, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, , Spain

Site Status RECRUITING

Hospital Universitario Nuestra Señora del Rosario

Madrid, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status RECRUITING

Clinica Fuensanta

Madrid, , Spain

Site Status RECRUITING

MD Anderson Cancer Center Madrid

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz: Servicio de Farmacia

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Ourense (CHOU)

Ourense, , Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Consorcio Hospital General Universitario de Valencia (CHGUV)

Valencia, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status RECRUITING

Ryhov Hospital

Jönköping, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

China Medical University Hospital

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

Site Status RECRUITING

Chiayi Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status NOT_YET_RECRUITING

Chiayi Chang Gung Memorial Hospital

Chiayi County, , Taiwan

Site Status NOT_YET_RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

Chang Gung Memorial Hospital Kaohsiung Branch

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

China Medical University Hospital - Pharmacy

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital Clinical Trials Pharmacy

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

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

Tainan, , Taiwan

Site Status RECRUITING

National Cheng-Kung University Hospital

Tainan, , Taiwan

Site Status RECRUITING

Chi Mei Hospital liouying

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital, Investigational Drug Service

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital - Clinical Trial Pharmacy

Taoyuan, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Barts Health NHS Trust , The Royal London Hospital

London, , United Kingdom

Site Status RECRUITING

Barts Health NHS Trust Saint Bartholomews Hospital

London, , United Kingdom

Site Status RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Guy's and St Thomas' NHS Foundation

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Canada Chile Czechia France Greece Hungary Ireland Israel Italy Japan Netherlands Peru Portugal Singapore South Korea Spain Sweden Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seagen Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=SGNDV-001

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C5731001

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501105-12-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

SGNDV-001

Identifier Type: -

Identifier Source: org_study_id

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