Clinical trial NCT05911295: Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
Official title: An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Urothelial Carcinoma
Keywords: Urothelial Cancer
LA/mUC
Bladder Cancer
HER2 Overexpression
HER2 Amplification
HER2
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: RemeGen Co., Ltd.
name: Merck Sharp & Dohme LLC
First posted: 2023-06-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
timeFrame: Approximately 3 years
measure: Overall survival (OS)
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Objective response rate (ORR) per RECIST v1.1 by BICR
timeFrame: Approximately 3 years
measure: ORR per RECIST v1.1 by investigator assessment
timeFrame: Approximately 3 years
measure: Duration of Response (DOR) per RECIST v1.1 by BICR
timeFrame: Approximately 3 years
measure: DOR per RECIST v1.1 by investigator assessment
timeFrame: Approximately 3 years
measure: Control Rate (DCR) per RECIST v1.1 by BICR
timeFrame: Approximately 3 years
measure: DCR per RECIST v1.1 by investigator assessment
timeFrame: Approximately 3 years
measure: PFS per RECIST v1.1 by investigator assessment
timeFrame: Approximately 3 years
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30 days after the last study treatment; approximately 2 years
measure: Number of participants with laboratory abnormalities
timeFrame: Through 30 days after the last study treatment; approximately 2 years
measure: Treatment discontinuation rate due to AEs
timeFrame: Approximately 2 years
measure: Number of electrocardiogram (ECG) abnormalities
timeFrame: Through 30 days after the last study treatment; approximately 2 years
measure: Change from baseline of left ventricular ejection fraction (LVEF)
timeFrame: Through 2 years after last study treatment; approximately 4 years
measure: Change from baseline to Week 16 in European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score
timeFrame: Approximately 2 years
measure: Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score
timeFrame: Approximately 2 years
measure: Time to pain progression
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Gateway Medical Center
state: Arizona
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Alhambra
country: United States
facility: UCLA Hematology/Oncology - Alhambra
state: California
city: Arcadia
country: United States
facility: Foothill Cardioology
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Multi-Specialties Practice
state: California
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Burbank
country: United States
facility: UCLA Burbank Cardiology
state: California
city: Burbank
country: United States
facility: UCLA Hematology/Oncology - Burbank
state: California
city: Calabasas
country: United States
facility: UCLA Calabasas Specialty Care
state: California
city: Encino
country: United States
facility: UCLA Encino Specialty Care (Radiology)
state: California
city: Encino
country: United States
facility: UCLA Hematology/Oncology - Encino
state: California
city: Glendale
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Glendora
country: United States
facility: Foothill Cardiology Glendora
state: California
city: Long Beach
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Los Angeles
country: United States
facility: UCLA Downtown Los Angeles Primary & Specialty Care
state: California
city: Los Angeles
country: United States
facility: Administrative Address: UCLA Hematology/Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA Cardiovascular Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology & Oncology Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology / Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA Westwood Specialty Care
state: California
city: Montecito
country: United States
facility: UCLA Montecito Primary & Specialty Care
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Newport Beach
country: United States
facility: Newport Diagnostics
state: California
city: Pasadena
country: United States
facility: Foothill Cardiology Pasadena
state: California
city: Pasadena
country: United States
facility: Southern California Heart Specialists
state: California
city: Porter Ranch
country: United States
facility: UCLA Porter Ranch Primary & Specialty Care
state: California
city: San Francisco
country: United States
facility: UCSF Center at China Basin Imaging
state: California
city: San Francisco
country: United States
facility: Helen Diller Family Comprehensive Cancer Center - Imaging Divisadero
state: California
city: San Francisco
country: United States
facility: Helen Diller Family Comprehensive Cancer Center - Imaging Post
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center MZ Phlebotomy
state: California
city: San Francisco
country: United States
facility: UCSF Mount Zion Phlebotomy
state: California
city: San Francisco
country: United States
facility: Helen Diller Family Comprehensive Cancer Center - Imaging Parnassus
state: California
city: San Francisco
country: United States
facility: UCSF Parnassus Phlebotomy
state: California
city: San Francisco
country: United States
facility: UCSF Parnassus-5 Lab
state: California
city: San Francisco
country: United States
facility: Cardiovascular Care and Prevention Center at Mission Bay
state: California
city: San Francisco
country: United States
facility: UCSF Investigational Drugs Pharmacy
state: California
city: San Francisco
country: United States
facility: UCSF Mission Bay Gateway-2 Lab
state: California
city: San Francisco
country: United States
facility: UCSF Mission Bay PCMB-5 Lab
state: California
city: San Francisco
country: United States
facility: UCSF Mission Bay Pediatric Clinical Research Center
state: California
city: San Francisco
country: United States
facility: UCSF Mission Bay Radiology and Nuclear Medicine
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco | HDFCCC - Hematopoietic malignancies
state: California
city: San Gabriel
country: United States
facility: Diagnostic Medical Group of Southern California, , San Gabriel, CA
state: California
city: San Gabriel
country: United States
facility: Southern California Heart Centers
state: California
city: San Luis Obispo
country: United States
facility: UCLA Hematology/Oncology - San Luis Obispo
state: California
city: San Luis Obispo
country: United States
facility: Sierra Vista Regional Medical Center
state: California
city: Santa Ana
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Santa Barbara
country: United States
facility: UCLA Hematology/Oncology - Santa Barbara
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Simi Valley
country: United States
facility: UCLA Simi Valley Alamo Specialty Care
state: California
city: Templeton
country: United States
facility: Twin Cities Community Hospital
state: California
city: Thousand Oaks
country: United States
facility: UCLA Thousand Oaks Primary & Specialty Care
state: California
city: Torrance
country: United States
facility: UCLA Hematology/Oncology - Torrance
state: California
city: Torrance
country: United States
facility: UCLA Torrance Lomita Specialty Care
state: California
city: Valencia
country: United States
facility: UCLA Santa Clarita Primary & Specialty Care
state: California
city: Ventura
country: United States
facility: UCLA Ventura Cardiology
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology/Oncology - Westlake
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Burnsville
country: United States
facility: M Health Fairview Ridges Cancer Clinic
state: Minnesota
city: Burnsville
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Coon Rapids
country: United States
facility: Allina Health Cancer institute
state: Minnesota
city: Coon Rapids
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Edina
country: United States
facility: M Health Fairview Cancer Clinic-Edina
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology Hematology Pa
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Maple Grove
country: United States
facility: M Health Fairview Maple Grove Cancer Center
state: Minnesota
city: Maplewood
country: United States
facility: M Health Fairview St. John's Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA
state: Minnesota
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute (Virginia Piper Cancer Institute)
state: Minnesota
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute-United(VPCI)
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin Country Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Investigational Drug Services
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Health Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: HealthPartners Institute
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium(MMCORC)
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Allina Health Cancer Institute-United(VPCI)
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Wyoming
country: United States
facility: M Health Fairview Lakes Medical Center
state: Minnesota
city: Bellevue
country: United States
facility: Nebraska Medicine- Bellevue Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine -Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine-Cancer Center at Village Pointe Health Center
state: Nebraska
city: Omaha
country: United States
facility: The University of Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Optum Care Cancer Care at Seven Hills
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer center
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Center Care at Fort Apache
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Ship study drug to: Mount Sinai Hospital- Pharmacy Dept
state: New York
city: Greenville
country: United States
facility: ECU Health Medical Center
state: North Carolina
city: Erie
country: United States
facility: AHN Saint Vincent Hospital
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: AHN Jefferson Hospital
state: Pennsylvania
city: Monroeville
country: United States
facility: AHN Forbes Hospital
state: Pennsylvania
city: Natrona Heights
country: United States
facility: Allegheny Valley Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN Cancer Institute - Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN Cancer Institute Pharmacy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Redbird
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Simmons Cancer Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: UT Southwestern - Simmons Cancer Center - Fort Worth
state: Texas
city: Richardson
country: United States
facility: UT Southwestern - Simmons Cancer Center - Richardson/Plano
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institue Infusion Pharmacy
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center.
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Viedma
country: Argentina
facility: Clinica Viedma
state: RIO Negro
city: Viedma
country: Argentina
facility: Fundación Dr. Ruben Kowalyszyn
state: RÍO Negro
city: Viedma
country: Argentina
facility: Comisión Provincial de Evaluación de Proyectos de Investigación en Salud Humana (CEEPISH)
state: RÍO Negro
city: San Miguel de Tucumán
country: Argentina
facility: SIPROSA - Sistema Provincial de Salud
state: Tucumán
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion de Buenos Aires (COIBA)
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
city: Buenos Aires
country: Argentina
facility: CEMIC - Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno
city: Buenos Aire
country: Argentina
facility: Centro Medico Austral
city: Buenos Aire
country: Argentina
facility: Centro Oncologico Korben
city: Caba
country: Argentina
facility: Fundacion Cenit
city: Caba
country: Argentina
facility: Investigaciones Clinicas Moleculares (ICM)
city: Cordoba
country: Argentina
facility: CEMAIC - Centro Medico Privado
city: Morón
country: Argentina
facility: Hospital Municipal de Morón. O. B. Lavignolle
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Rosario
country: Argentina
facility: Comité Provincial de Bioética-Rosario
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: Salta
country: Argentina
facility: Consultorio Dr. Miguel Angel Escudero
city: Salta
country: Argentina
facility: Oncologia Salta
city: Tucuman
country: Argentina
facility: Centro para la Atencion Integral del paciente Oncologico
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Saint Vincents Hospital Sydney - Human Research Ethics Committee
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Clinic
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Misericordiae - Mater Hospital Brisbane
state: Queensland
city: Herston
country: Australia
facility: Icon Cancer Centre Chermside
state: Queensland
city: South Bribane
country: Australia
facility: Mater Research
state: Queensland
city: Eastwood
country: Australia
facility: Bellberry Limited
state: South Australia
city: Frankston
country: Australia
facility: Peninsula & South Eastern Hematology and Oncology Group (PASO)
state: Victoria
city: Caringbah
country: Australia
facility: South Eastern Sydney Local Health District
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
city: Frankston
country: Australia
facility: Peninsula And South East Oncology
city: Malvern
country: Australia
facility: Cabrini.
city: NSW
country: Australia
facility: Mid North Coast Local Health District
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Ghent
country: Belgium
facility: AZ St. Lucas
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Namur
country: Belgium
facility: CHU UCL Namur-Site de Saint Elisabeth
city: Wilrijk
country: Belgium
facility: GZA Hospital Sint-Augustinus
city: Salvador
country: Brazil
facility: Centro de Oncologia da Bahia
state: BA
city: Fortaleza
country: Brazil
facility: Suporte Nutricional e Quimioterapia - PRONUTRIR
state: Ceará
city: Belo Horizonte
country: Brazil
facility: Associacao Mario Penna - Hospital Luxemburgo - NEPI Nucleo de Ensino Pesquisa e Inovacao
state: MG
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao / Grupo Hospitalar Conceicao
state: RS
city: Jaú
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
state: SÃO Paulo
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos - Fundacao Pio XII
city: CuriBba
country: Brazil
facility: Erasto Gaertner Hospital
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta / Cross Cancer Institute
state: Alberta
city: Oshawa
country: Canada
facility: Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre - University Health Network
state: Ontario
city: Los Condes
country: Chile
facility: Centro de Oncología de Precisión
state: Region Metropolitana Santiago
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA
city: Vina del mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
city: Besancon
country: France
facility: University Hospital of Besancon
city: Bordeaux Cedex
country: France
facility: Institut Bergonié Centre de Lutte Contre le Cancer (CLCC)
city: Caen Cedex 5
country: France
facility: Centre de Lutte contre le Cancer - François Baclesse
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: MONTPELLIER Cedex 5
country: France
facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
city: MONTPELLIER Cedex 5
country: France
facility: Pharmacy ICM Val d'Aurelle - Bat A - Rez-de-Jardin
city: Nice Cedex 2
country: France
facility: Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon
city: Strasbourg
country: France
facility: Unite de Coordination de la Biologie des Essais Cliniques
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Cholargos
country: Greece
facility: Metropolitan General Hospital
city: Cork
country: Ireland
facility: Cancer Trials Cork
city: Tallaght
country: Ireland
facility: Tallaght University Hospital
city: Wilton
country: Ireland
facility: Cork University Hospital
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Other
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Other
city: Ramat Gan
country: Israel
facility: Sheba Medical Center.
state: Other
city: Afula
country: Israel
facility: Emek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Hafia
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Rambam Health Corp.
city: Kefar Sava
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
state: Apulia
city: Tricase
country: Italy
facility: Azienda Ospedaliera Cardinale Giovanni Panico
state: Apulia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.
state: Campania
city: Ravenna
country: Italy
facility: Oncologia Medica, Ospedale Civile S. Maria delle Croci
state: Emilia-romagna
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: Liguria
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardy
city: Rozzano (Milano)
country: Italy
facility: Istituto Clinico Humanitas-Humanitas Cancer Center
state: Lombardy
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: Milano
city: Milano
country: Italy
facility: IRCCS - Ospedale San Raffaele
state: Milan
city: Giugliano in Campania
country: Italy
facility: Azienda Sanitaria Locale Napoli 2 Nord
state: Naples
city: Pozzuoli (NA)
country: Italy
facility: P.O. "S. Maria Delle Grazie" - Pozzuoli - ASL Napoli Nord 2
state: Other
city: Asti
country: Italy
facility: ASL-AT, Ospedale Cardinal Massaia di Asti
state: Piemonte
city: Aviano
country: Italy
facility: SOSD Farmacia Ospedaliera
state: Pordenone
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico Di Aviano
state: Pordenone
city: Lugo
country: Italy
facility: AUSL Romagna - Presidio Ospedale "Umberto I" di Lugo
state: Ravenna
city: Faenza
country: Italy
facility: AUSL della Romagna - Ospedale degli infermi
state: RA
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
state: Tuscany
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria di Terni
state: Umbria
city: Asti
country: Italy
facility: ASL Asti - Ospedale Cardinal Massaia - S.C. Farmacia Ospedaliera
city: Cremona
country: Italy
facility: ASST Cremona Farmacia Ospedaliera
city: Firenze
country: Italy
facility: U.O. Farmacia Ospedaliera a Politiche del Farmaco Az. Osp. Universitaria Careggi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino Farmacia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana, U.O. Farmacia Ospedaliera
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona Srl
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Ota-Shi
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka-fu
city: Suita-city
country: Japan
facility: Osaka University Hopsital
state: Osaka
city: Tokushima-Shi
country: Japan
facility: Tokushima University Hospital
state: Tokushima
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Iksan-si
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeonlabuk-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - Oncology
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF
state: Akershus
city: Stavanger
country: Norway
facility: Avdeling for blod og kreft sykdommer. Stavanger universitetssykehus
city: Lima
country: Peru
facility: Hospital Militar Central Coronel Luis Arias Schreiber
city: Lima
country: Peru
facility: Hospital Maria Auxiliadora
city: Sao Victor
country: Portugal
facility: Hospital de Braga
state: Braga
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Centro Clinico Champalimaud
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria - Centro Hospitalar Universitario Lisboa Norte
city: Lisbon
country: Portugal
facility: Champalimaud Clinical Center
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National University Cancer Institute
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruna
city: Santiago de Compostela
country: Spain
facility: Farmacia Oncologica - Unidad de Ensayos Clinicos
state: A Coruna
city: Badalona
country: Spain
facility: Institut Catala d' Oncologia de Badalona - Hospital Universitari Germans Trias i Pujos
state: Barcelona
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau- Pharmacy
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: L'Hospitaler De Llobregat
country: Spain
facility: Unitat d'Assajos Clinics Servei de Farmacia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz: Servicio de Farmacia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: HM Centro Integral Oncologico Clara Campal
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense (CHOU)
city: Uppsala
country: Sweden
facility: Uppsala University Hospital (Akademiska Sjukhuset)
state: Uppland
city: Jonkoping
country: Sweden
facility: Ryhov Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital - Pharmacy
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital Clinical Trials Pharmacy
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital liouying
city: Tainan
country: Taiwan
facility: Clinical Trial Pharmacy, Department of Pharmacy, National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Investigational Drug Service
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust Saint Bartholomews Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: