Clinical trial NCT06136624: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Official title: A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer Metastatic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2023-11-18
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.


Eligibility criteria: Inclusion Criteria:

* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
* Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
* Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
* Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
* If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
* Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom

Exclusion Criteria:

* Has a gastrointestinal disorder that might affect absorption
* Has a history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
* Has a history of clinically significant ventricular arrhythmias
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate) within 4 weeks before the date of randomization
* Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
* Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
* Has received colony-stimulating factors within 28 days before the date of randomization
* Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
* Has a "superscan" bone scan
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has concurrent active HBV or known active HCV infection
* Has a history of long QTc syndrome
* Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
* Is unable to swallow capsules/tablets
* Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
* Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention

Primary outcomes:
measure: Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants
timeFrame: Up to ~54 months
measure: OS in AR LBD Mutation-Negative Participants
timeFrame: Up to ~54 months
measure: Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participant
timeFrame: Up to ~36 months
measure: rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants
timeFrame: Up to ~36 months
Secondary outcomes:
measure: Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
timeFrame: Up to ~54 months
measure: Objective Response (OR)
timeFrame: Up to ~54 months
measure: Duration of Response (DOR)
timeFrame: Up to ~54 months
measure: Time to Pain Progression (TTPP)
timeFrame: Up to ~54 months
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to ~54 months
measure: Time to First Symptomatic Skeletal-related Event (SSRE)
timeFrame: Up to ~54 months
measure: Number of Participants Who Experience an Adverse Event
timeFrame: Up to ~54 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
timeFrame: Up to ~54 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center ( Site 0036)
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center ( Site 0099)
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion ( Site 0046)
state: Colorado
city: Highlands Ranch
country: United States
facility: University of Colorado Health - Highlands Ranch Hospital ( Site 0111)
state: Colorado
city: Lakewood
country: United States
facility: Colorado Clinical Research ( Site 0067)
state: Colorado
city: Lone Tree
country: United States
facility: University of Colorado Health - Lone Tree Medical Center ( Site 0112)
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South ( Site 7003)
state: Florida
city: Miami
country: United States
facility: Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago ( Site 0105)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 0045)
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa ( Site 0047)
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center ( Site 0048)
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation ( Site 0108)
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Veterans Affairs Medical Center ( Site 0069)
state: Maryland
city: Baltimore
country: United States
facility: Greenebaum Comprehensive Cancer Center ( Site 0049)
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0015)
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview Clinics and Surgery Center ( Site 0019)
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro-Minnesota Community Clinical Oncology ( Site 0014)
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062)
state: Missouri
city: Omaha
country: United States
facility: University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095)
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0010)
state: Nevada
city: Morristown
country: United States
facility: Atlantic Health System Morristown Medical Center ( Site 0115)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0033)
state: New Jersey
city: Bronx
country: United States
facility: James J. Peters VA Medical Center ( Site 0088)
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0043)
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University ( Site 0028)
state: Oregon
city: Portland
country: United States
facility: VA Portland Health Care System ( Site 0058)
state: Oregon
city: Pittsburgh
country: United States
facility: AHN Allegheny General Hospital ( Site 0001)
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
state: South Carolina
city: Pierre
country: United States
facility: Avera Cancer Institute - Pierre ( Site 0118)
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute- Research ( Site 0094)
state: South Dakota
city: Yankton
country: United States
facility: Avera Cancer Institute - Yankton ( Site 0117)
state: South Dakota
city: Nashville
country: United States
facility: SCRI Oncology Partners ( Site 7000)
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Central/South Texas ( Site 8003)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - DFW ( Site 8001)
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Gulf Coast ( Site 8002)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System ( Site 0054)
state: Virginia
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0061)
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0004)
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center ( Site 0013)
state: Washington
city: Milwaukee
country: United States
facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
state: Wisconsin
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 0202)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
state: Caba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming-Alexander Fleming ( Site 0206)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0208)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0207)
city: Mendoza
country: Argentina
facility: Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204)
city: Dubbo
country: Australia
facility: Dubbo Hospital ( Site 0235)
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 0234)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0232)
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital-Cancer Care Serices ( Site 0237)
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230)
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276)
state: Oberosterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH ( Site 0279)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280)
state: Steiermark
city: Salvador
country: Brazil
facility: Obras Sociais Irma Dulce ( Site 0302)
state: Bahia
city: Vitoria
country: Brazil
facility: Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320)
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho ( Site 0317)
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Mario Penna ( Site 0309)
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314)
state: Parana
city: Itajai
country: Brazil
facility: Clínica de Neoplasias Litoral ( Site 0305)
state: Santa Catarina
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 0310)
state: Sao Paulo
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0332)
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0331)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0330)
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 0326)
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329)
state: Quebec
city: La Serena.
country: Chile
facility: IC La Serena Research ( Site 0356)
state: Coquimbo
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA ( Site 0358)
state: Los Rios
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule-Oncology ( Site 0355)
state: Maule
city: Santiago
country: Chile
facility: FALP ( Site 0353)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0351)
state: Region M. De Santiago
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0357)
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408)
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital-Urology ( Site 0390)
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University ( Site 0396)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Urinary Surgery ( Site 0395)
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University ( Site 0427)
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 0416)
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital of Third Military Medical University ( Site 0420)
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital's ( Site 0426)
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-Urology ( Site 0415)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 0412)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413)
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 0407)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital-Urinary surgery ( Site 0406)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0405)
state: Hunan
city: Huaian
country: China
facility: First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436)
state: Jiangsu
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377)
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated hospital of Jiangnan university ( Site 0434)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital ( Site 0386)
state: Jiangxi
city: XI An
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394)
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393)
state: Shaanxi
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital ( Site 0397)
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Urology department ( Site 0376)
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University-Urology Surgery ( Site 0417)
state: Sichuan
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu (CDTPH) ( Site 0428)
state: Sichuan
city: Nanchong
country: China
facility: Nanchong Central Hospital-urology ( Site 0422)
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital ( Site 0437)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0392)
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University ( Site 0391)
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419)
state: Xinjiang
city: Kunming
country: China
facility: The Second Affiliated Hospital Of Kunming Medical University ( Site 0429)
state: Yunnan
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 0418)
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital-Urology ( Site 0378)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0435)
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing-urology ( Site 0380)
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University ( Site 0383)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379)
state: Zhejiang
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502)
state: Cesar
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 0504)
state: Cordoba
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501)
state: Distrito Capital De Bogota
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia ( Site 0503)
state: Santander
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0505)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S ( Site 0509)
state: Valle Del Cauca
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554)
state: Moravskoslezsky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555)
state: Olomoucky Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551)
state: Praha 5
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 0576)
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense Universitetshospital-Department of oncology ( Site 0579)
state: Syddanmark
city: Vejle
country: Denmark
facility: Vejle Sygehus ( Site 0578)
state: Syddanmark
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala ( Site 0604)
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala ( Site 0603)
state: Pohjois-Savo
city: Turku
country: Finland
facility: Turku University Hospital-Department of Oncology ( Site 0601)
state: Varsinais-Suomi
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627)
state: Alsace
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630)
state: Gard
city: Rennes
country: France
facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632)
state: Ille-et-Vilaine
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629)
state: Puy-de-Dome
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque ( Site 0633)
state: Pyrenees-Atlantiques
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0626)
state: Val-de-Marne
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou ( Site 0628)
city: Munich
country: Germany
facility: klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696)
state: Bayern
city: Schwerin
country: Germany
facility: HELIOS Kliniken Schwerin ( Site 0694)
state: Mecklenburg-Vorpommern
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680)
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678)
state: Nordrhein-Westfalen
city: Lubeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691)
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 0727)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 0730)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752)
state: Bacs-Kiskun
city: Salgótarján
country: Hungary
facility: Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761)
state: Nograd
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756)
state: Pest
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758)
city: Dublin 04
country: Ireland
facility: St. Vincent's University Hospital ( Site 0802)
state: Dublin
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0801)
city: Afula
country: Israel
facility: Emek Medical Center ( Site 0830)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0826)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0833)
city: Kfar Saba
country: Israel
facility: Meir Medical Center. ( Site 0832)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0828)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0827)
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879)
state: Emilia-Romagna
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877)
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 0876)
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 0906)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 0918)
state: Ehime
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921)
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0920)
state: Fukuoka
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital ( Site 0901)
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 0902)
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 0931)
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital ( Site 0914)
state: Hyogo
city: Uchinada
country: Japan
facility: Kanazawa Medical University Hospital ( Site 0909)
state: Ishikawa
city: Kita
country: Japan
facility: Kagawa University Hospital ( Site 0917)
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0908)
state: Kanagawa
city: Ōmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center ( Site 0923)
state: Nagasaki
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0915)
state: Nara
city: Shimajiri
country: Japan
facility: Nanbu Tokushukai Hospital ( Site 0930)
state: Okinawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0912)
state: Osaka
city: Sakai
country: Japan
facility: Bell Land General Hospital ( Site 0913)
state: Osaka
city: Suita
country: Japan
facility: The University of Osaka Hospital ( Site 0911)
state: Osaka
city: Saga-shi
country: Japan
facility: Saga-Ken Medical Centre Koseikan ( Site 0922)
state: Saga
city: Minato
country: Japan
facility: The Jikei University Hospital ( Site 0907)
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital ( Site 0904)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0919)
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 0933)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 0910)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0916)
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital ( Site 0929)
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center ( Site 0924)
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital ( Site 0927)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 0926)
city: Nagano
country: Japan
facility: Nagano Municipal Hospital ( Site 0932)
city: Oita
country: Japan
facility: National Hospital Organization Oita Medical Center ( Site 0925)
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center-Oncology ( Site 1402)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Oncology ( Site 1401)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1405)
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail ( Site 1081)
state: Johor
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 1077)
state: Kuala Lumpur
city: Kuching
country: Malaysia
facility: Sarawak General Hospital-Radiotherapy Unit ( Site 1076)
state: Sarawak
city: Putrajaya
country: Malaysia
facility: National Cancer Institute ( Site 1079)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078)
city: Mexico City
country: Mexico
facility: Quemex Medical and Research ( Site 1112)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103)
state: Jalisco
city: Monterrey
country: Mexico
facility: Filios Alta Medicina ( Site 1106)
state: Nuevo Leon
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV ( Site 1108)
state: Yucatan
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 1109)
city: Leeuwarden
country: Netherlands
facility: Medische Centrum Leeuwarden ( Site 1172)
state: Fryslan
city: Nijmegen
country: Netherlands
facility: Radboudumc-Medical Oncology ( Site 1152)
state: Gelderland
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163)
state: Limburg
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum ( Site 1173)
state: Limburg
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth-Internal Medicine ( Site 1160)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153)
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc ( Site 1156)
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170)
state: Noord-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum ( Site 1157)
state: Utrecht
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164)
state: Zuid-Holland
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151)
state: Zuid-Holland
city: Tauranga
country: New Zealand
facility: Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201)
state: Bay Of Plenty
city: Dunedin
country: New Zealand
facility: Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203)
state: Otago
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227)
state: Akershus
city: Sarpsborg
country: Norway
facility: Sykehuset Østfold Kalnes ( Site 1228)
state: Ostfold
city: Trondheim
country: Norway
facility: St. Olavs Hospital-Kreftklinikken ( Site 1231)
state: Sor-Trondelag
city: Concepcion
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258)
state: Junin
city: Trujillo
country: Peru
facility: Clínica Sánchez Ferrer ( Site 1261)
state: La Libertad
city: Lima
country: Peru
facility: Aliada-Oncologìa ( Site 1257)
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254)
city: Lima
country: Peru
facility: Oncosalud-Clinical Research ( Site 1260)
city: Lima
country: Peru
facility: INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302)
state: Kujawsko-pomorskie
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316)
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304)
state: Kujawsko-pomorskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)
state: Mazowieckie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318)
state: Swietokrzyskie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii ( Site 1311)
state: Zachodniopomorskie
city: Hato Rey
country: Puerto Rico
facility: Puerto Rico Medical Research Center LLC ( Site 1354)
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research-Research ( Site 1353)
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials - Ciudadela ( Site 1351)
city: Singapore
country: Singapore
facility: National University Hospital ( Site 1376)
state: Central Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 1377)
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital-Medical Oncology ( Site 1378)
state: Central Singapore
city: Jerez de la Frontera
country: Spain
facility: Hospital Jerez de la Frontera ( Site 1427)
state: Cadiz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433)
state: Madrid, Comunidad De
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense ( Site 1426)
state: Orense
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430)
state: Valenciana, Comunitat
city: Lugo
country: Spain
facility: Hospital Lucus Augusti-Oncology ( Site 1432)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1478)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477)
state: Uppsala Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset ( Site 1479)
state: Vastra Gotalands Lan
city: Taichung
country: Taiwan
facility: China Medical University Hospital-Department of Urology ( Site 1503)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Urology ( Site 1502)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Urology ( Site 1506)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1505)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504)
city: Muang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University ( Site 1526)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 1530)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 1531)
state: Krung Thep Maha Nakhon
city: Hatyai
country: Thailand
facility: Songklanagarind hospital ( Site 1527)
state: Songkhla
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554)
city: Ankara
country: Turkey
facility: Gulhane Egitim Arastirma Hastanesi ( Site 1558)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 1557)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 1605)
state: Cambridgeshire
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 1610)
state: England
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 1603)
state: Glasgow City
city: London
country: United Kingdom
facility: Charing Cross Hospital-Oncology Research ( Site 1606)
state: Hammersmith And Fulham
city: London
country: United Kingdom
facility: University College London Hospital ( Site 1612)
state: London, City Of
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1608)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: