Clinical trial NCT04527991: Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Official title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced or Metastatic Unresectable Urothelial Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 696
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: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).


Eligibility criteria: Key Inclusion Criteria:

1. Individuals with histologically documented metastatic or locally advanced unresectable UC defined as

   * Tumor (T) 4b, any node (N) or
   * Any T, N 2-3 Tumors of upper and lower urinary tract are permitted. Mixed histologic types are allowed if urothelial is the predominant histology.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
3. Individuals with progression or recurrence following receipt of platinum-containing regimen and anti programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) therapy for metastatic or locally advanced unresectable disease will be enrolled.

   * a. Individuals with recurrence or progression ≤12 months following completion of cisplatin-containing chemotherapy given in the neo-adjuvant/adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or platinum therapy, respectively. These individuals must receive anti PD-1/PD-L1 therapy in the metastatic or locally advanced unresectable setting to be eligible.
   * b. Individuals who received either carboplatin or anti PD-1/PD-L1 therapy in the neo- adjuvant/adjuvant setting will not be able to count that line of therapy towards eligibility for the study.
   * c. Cisplatin ineligible individuals who meet one of the below criteria and who were treated with carboplatin in the metastatic or locally advanced unresectable settings may count that line of therapy towards eligibility. They must then have received anti PD-1/PD-L1 therapy in metastatic or locally advanced unresectable setting to be eligible for the study.

     * Cisplatin ineligibility is defined as meeting one of the following criteria:

       * 1. Creatinine Clearance \< 60 mL/min
       * 2. Grade ≥ 2 Audiometric Hearing Loss
       * 3. Grade ≥ 2 Peripheral Neuropathy
       * 4. New York Heart Association (NYHA) Class III heart failure
       * 5. ECOG PS ≥ 2
   * d. Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
   * e. Individuals who have progressed after receiving enfortumab vedotin in prior lines of therapy, and individuals who are either ineligible or unable to tolerate enfortumab vedotin therapy, are eligible to enroll in the study
   * f. Individuals who received only concurrent chemoradiation for bladder preservation without further systemic therapy are not eligible to enroll in the study. The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.
4. Individuals with previously treated brain metastases may participate in the study provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and stabilization of all neurologic symptoms, have no evidence of new or enlarging brain metastases, and are not using steroids \>20 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to first dose of the study drug.
5. Adequate hematologic counts without transfusion or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm\^3, and platelets ≥100,000/µL).
6. Adequate hepatic function (bilirubin ≤1.5x institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin \>3 g/dL).

   Docetaxel will only be option in TPC arm for Individuals with a total bilirubin ≤1 x IULN, and an AST and/or ALT ≤1.5x IULN if alkaline phosphatase is also \>2.5 x IULN.
7. Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation or other validated instruments (e.g. Modification of Diet in Renal Disease (MDRD) equation).
8. Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
9. Females of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study drug. Individuals of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>2 years.
10. Males must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Key Exclusion Criteria:

1. Females who are pregnant or lactating.
2. Have had a prior anti-cancer monoclonal antibody (mAb)/ antibody-drug conjugate (ADC) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible.
3. Have received prior chemotherapy for UC with any available SOC therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an approved therapy, or prior paclitaxel, docetaxel and vinflunine in regions where vinflunine is approved and is commercially available).
4. Have not recovered (i.e., ≤ Grade 1) from AEs due to previously administered chemotherapeutic agent.

   * Note: Individuals with ≤ Grade 2 neuropathy or any grade of alopecia are an exception to this criterion and will qualify for the study.
   * Note: If Individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy.
5. Have previously received topoisomerase 1 inhibitors.
6. Have an active second malignancy.

   • Note: Individuals with a history of malignancy that have been completely treated and with no evidence of active cancer for 3 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll in the study after discussion with the medical monitor.
7. Have active cardiac disease, defined as:

   * Myocardial infarction or unstable angina pectoris within 6 months of C1D1.
   * History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
   * NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of \<40%.
8. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
9. Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
10. Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.
11. Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In individuals with a history of HBV or HCV, individuals with a detectable viral load will be excluded.
12. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
13. Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab govitecan-hziy or unable or unwilling to receive the doses specified in the protocol.
14. Have inability to complete all specified study procedures for any reason.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3.5 years
Secondary outcomes:
measure: Progression-Free Survival (PFS) by Investigator Assessment
timeFrame: Up to 3.5 years
measure: Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
timeFrame: Up to 3.5 years
measure: Objective Response Rate (ORR) by Investigator Assessment
timeFrame: Up to 3.5 years
measure: Objective Response Rate (ORR) by BICR
timeFrame: Up to 3.5 years
measure: Clinical Benefit Rate (CBR) by Investigator Assessment
timeFrame: Up to 3.5 years
measure: Clinical Benefit Rate (CBR) by BICR
timeFrame: Up to 3.5 years
measure: Duration of Objective Tumor Response (DOR) by Investigator Assessment
timeFrame: Up to 3.5 years
measure: Duration of Objective Tumor Response (DOR) by BICR
timeFrame: Up to 3.5 years
measure: Percentage of Participants Experiencing any Treatment Emergent Adverse Events
timeFrame: Up to 3.5 years
measure: Percentage of Participants Experiencing any Serious Treatment Emergent Adverse Events
timeFrame: Up to 3.5 years
measure: Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities
timeFrame: Up to 3.5 years
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score
timeFrame: Up to 3.5 years
measure: European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score
timeFrame: Up to 3.5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/ Oncology
state: California
city: Orange
country: United States
facility: University of California Irvine (UCIMC)
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Plantation
country: United States
facility: Boca Raton Clinical Research Global USA - Plantation
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute (OCSRI)
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Oncology Group - Knoxville Downtown
state: Tennessee
city: Knoxville
country: United States
facility: University Cancer Specialists - Knoxville
state: Tennessee
city: Dallas
country: United States
facility: Harold C. Simmons Comprehensive Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance (SCCA)
state: Washington
city: Spokane
country: United States
facility: Summit Cancer Centers
state: Washington
city: North Ryde
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Centre Wesley
state: Queensland
city: Bedford Park
country: Australia
facility: Southern Adelaide Local Health Network Incorporated
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research - ICON Cancer Centre Adelaide
state: South Australia
city: Hobart
country: Australia
facility: ICON Cancer Centre Hobart
state: Tasmania
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Saint Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Liverpool Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Graz
country: Austria
facility: Universitätsklinik für Innere Medizin Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Wien
country: Austria
facility: Krankenhaus Der Barmherzigen Bruder Wien
city: Charleroi
country: Belgium
facility: Grand Hôpital De Charleroi - Notre Dame
city: Gent
country: Belgium
facility: Az Maria Middelares Ghent
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Pleven
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Halifax
country: Canada
facility: qeii health sciences centre - VG site
city: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Centre
city: London
country: Canada
facility: London Health Sciences Centre
city: Montréal
country: Canada
facility: Jewish General Hospital
city: Montréal
country: Canada
facility: McGill University Health Centre
city: Oshawa
country: Canada
facility: R.S. McLaughlin Durham Regional Cancer Centre
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency-Vancouver Centre
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital - 301 Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Cancer Hospital
city: Changchun
country: China
facility: 1st Hospital Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital - Xiangya Hospital - Central South University
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fujian
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Fuzhou
country: China
facility: Union Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital - Zhaohui
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Urumqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Split
country: Croatia
facility: Clinical Hospital Centre Split
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre "Sestre Milosrdnice"
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Urocentrum Praha
city: Bayonne
country: France
facility: Ramsay Health Clinic Belharra
city: Bordeaux
country: France
facility: CHU Saint Andre
city: Brest
country: France
facility: Centre Hospiltalier Universitaire Brest - Hôpital Morvan
city: Caen Cedex 5
country: France
facility: Centre Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges- Francois Leclerc
city: La Roche-Sur-Yon Cedex
country: France
facility: Centre Hospitalier Departemental Vendee
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier ICM Val d' Aurelle
city: Nice Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nimes
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Rennes Cedex
country: France
facility: Centre Eugene Marquis
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé Saint-Grégoire
city: Strasbourg cedex
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Batumi
country: Georgia
facility: High Technology Hospital MedCenter
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: L. Managadze National Center of Urology
city: Tbilisi
country: Georgia
facility: Evex Medical corporation
city: Tbilisi
country: Georgia
facility: Jerarsi Clinic
city: Dresden
country: Germany
facility: Universitatsklinik Dresden
city: Erlangen
country: Germany
facility: Malteser Waldkrankenhaus Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Centrum fur Hamatologie und Onkologie Bethanien
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Koblenz
country: Germany
facility: Institut Für Versorgungsforschung in Der Onkologie
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Wien
country: Germany
facility: Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
city: Athens
country: Greece
facility: 401 General Military Hospital of Athens
city: Athens
country: Greece
facility: Henry Dunant Hospital
city: Athens
country: Greece
facility: Alexandra General Hospital
city: Chaidari
country: Greece
facility: Attikon Hospital
city: Herakleio
country: Greece
facility: Regional University General Hospital of Herakleio, Crete
city: Ioannina
country: Greece
facility: University Hospital Of Ioannina
city: Larisa
country: Greece
facility: University Hospital of Larissa
city: Maroussi
country: Greece
facility: Athens Medical Center
city: Patra
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Bioclinic - Thessaloniki
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Anassa General Clinic
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Be'er Ya'akov
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Kfar-Sava
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center (Ichilov Hospital)
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Bari
country: Italy
facility: Istituto Tumori Bari Giovanni Paolo II - IRCCS
city: Candiolo (TO)
country: Italy
facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore Della Carita
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Istituto Regina Elena
city: Rome
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Sondrio
country: Italy
facility: Ospedale Civile Di Sondrio
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria di Terni
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
city: Trento
country: Italy
facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Busan-si
country: Korea, Republic of
facility: Pusan National University Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan 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: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul Saint Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea Saint Vincent's Hospital
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guarda
country: Portugal
facility: Unidade Local de Saúde da Guarda - Hospital Sousa Martins
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria - Hospital de Santo André
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Tras-os-Montes e Alto Douro
city: San Juan
country: Puerto Rico
facility: BRCR Medical Center, Inc
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Icon Cancer Centre Farrer Park
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Manresa
country: Spain
facility: Hospital Sant Joan de Déu de Manresa
city: Ourense
country: Spain
facility: Complexo Hospitalario de Ourense (CHOU)
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Vigo
country: Spain
facility: Álvaro Cunqueiro Hospital
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Linköping
country: Sweden
facility: Universitetssjukhuset i Linköping
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset - Solna
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico Della Svizzera Italiana (IOSI)
city: Bern
country: Switzerland
facility: University of Bern
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Zurich
country: Switzerland
facility: Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi General Hospital
city: Puzi
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu
city: Edirne
country: Turkey
facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Acibadem University Maslak Hospital
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
city: İzmir
country: Turkey
facility: Medical Park Izmır Hastanesi
city: Mamak
country: Turkey
facility: Cebeci Hastanesi
city: Şişli
country: Turkey
facility: VKV Amerikan Hastanesi Department of Oncology
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute London
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Middlesex
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Port Talbot
country: United Kingdom
facility: Swansea Bay University Health Board
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Surrey
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: