Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
NCT ID: NCT06136624
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1310 participants
INTERVENTIONAL
2023-12-31
2028-08-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abiraterone Acetate or Enzalutamide
Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.
Abiraterone acetate
Administered orally
Enzalutamide
Administered orally
Prednisone
Administered orally
Opevesostat
Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.
Opevesostat
Administered orally
Hydrocortisone
Administered orally or IM as a rescue medication
Fludrocortisone acetate
Administered orally
Dexamethasone
Administered orally as rescue medication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Opevesostat
Administered orally
Abiraterone acetate
Administered orally
Enzalutamide
Administered orally
Hydrocortisone
Administered orally or IM as a rescue medication
Fludrocortisone acetate
Administered orally
Prednisone
Administered orally
Dexamethasone
Administered orally as rescue medication
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
* Has current evidence of distant metastatic disease (M1 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 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, citrus pectin polysaccharide) 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Orion Corporation, Orion Pharma
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
Orange, California, United States
Stanford Cancer Center ( Site 0036)
Palo Alto, California, United States
Kaiser Permanente Riverside Medical Center ( Site 0099)
Riverside, California, United States
Anschutz Cancer Pavilion ( Site 0046)
Aurora, Colorado, United States
University of Colorado Health - Highlands Ranch Hospital ( Site 0111)
Highlands Ranch, Colorado, United States
Colorado Clinical Research ( Site 0067)
Lakewood, Colorado, United States
University of Colorado Health - Lone Tree Medical Center ( Site 0112)
Lone Tree, Colorado, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
New Haven, Connecticut, United States
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, United States
Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)
Miami, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)
Miami, Florida, United States
University of Illinois at Chicago ( Site 0105)
Chicago, Illinois, United States
University of Chicago Medical Center ( Site 0045)
Chicago, Illinois, United States
University of Iowa ( Site 0047)
Iowa City, Iowa, United States
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, United States
Ochsner Clinic Foundation ( Site 0108)
New Orleans, Louisiana, United States
Baltimore Veterans Affairs Medical Center ( Site 0069)
Baltimore, Maryland, United States
Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland, United States
Henry Ford Hospital ( Site 0015)
Detroit, Michigan, United States
M Health Fairview Clinics and Surgery Center ( Site 0019)
Minneapolis, Minnesota, United States
Metro-Minnesota Community Clinical Oncology ( Site 0014)
Saint Louis Park, Minnesota, United States
Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062)
St Louis, Missouri, United States
University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095)
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada ( Site 0010)
Las Vegas, Nevada, United States
Atlantic Health System Morristown Medical Center ( Site 0115)
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, New Jersey, United States
James J. Peters VA Medical Center ( Site 0088)
The Bronx, New York, United States
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, Ohio, United States
Oregon Health and Science University ( Site 0028)
Portland, Oregon, United States
VA Portland Health Care System ( Site 0058)
Portland, Oregon, United States
AHN Allegheny General Hospital ( Site 0001)
Pittsburgh, Pennsylvania, United States
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
Charleston, South Carolina, United States
Avera Cancer Institute - Pierre ( Site 0118)
Pierre, South Dakota, United States
Avera Cancer Institute- Research ( Site 0094)
Sioux Falls, South Dakota, United States
Avera Cancer Institute - Yankton ( Site 0117)
Yankton, South Dakota, United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas ( Site 8003)
Austin, Texas, United States
Texas Oncology - DFW ( Site 8001)
Dallas, Texas, United States
Texas Oncology - Gulf Coast ( Site 8002)
The Woodlands, Texas, United States
University of Virginia Health System ( Site 0054)
Charlottesville, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 0061)
Richmond, Virginia, United States
Blue Ridge Cancer Care ( Site 0004)
Roanoke, Virginia, United States
Fred Hutchinson Cancer Center ( Site 0013)
Seattle, Washington, United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
Milwaukee, Wisconsin, United States
Hospital Británico de Buenos Aires-Oncology ( Site 0202)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
Mar del Plata, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0206)
Buenos Aires, Buenos Aires F.D., Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Parque ( Site 0208)
Rosario, Santa Fe Province, Argentina
Hospital Aleman-Oncology ( Site 0207)
Buenos Aires, , Argentina
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204)
Mendoza, , Argentina
Dubbo Hospital ( Site 0235)
Dubbo, New South Wales, Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 0234)
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 0232)
Westmead, New South Wales, Australia
Princess Alexandra Hospital-Cancer Care Serices ( Site 0237)
Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230)
Melbourne, Victoria, Australia
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280)
Graz, Styria, Austria
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276)
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH ( Site 0279)
Wels, Upper Austria, Austria
Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320)
Vitória, Espírito Santo, Brazil
Obras Sociais Irma Dulce ( Site 0302)
Salvador, Estado de Bahia, Brazil
Hospital Felicio Rocho ( Site 0317)
Belo Horizonte, Minas Gerais, Brazil
Hospital Mario Penna ( Site 0309)
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314)
Curitiba, Paraná, Brazil
Clínica de Neoplasias Litoral ( Site 0305)
Itajaí, Santa Catarina, Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308)
Bragança Paulista, São Paulo, Brazil
A. C. Camargo Cancer Center ( Site 0310)
São Paulo, São Paulo, Brazil
Cross Cancer Institute ( Site 0332)
Edmonton, Alberta, Canada
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336)
Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0331)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0330)
Toronto, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328)
Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0326)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327)
Québec, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329)
Sherbrooke, Quebec, Canada
IC La Serena Research ( Site 0356)
La Serena, Coquimbo Region, Chile
Clinical Research Chile SpA ( Site 0358)
Valdivia, Los Ríos Region, Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0355)
Talca, Maule Region, Chile
FALP ( Site 0353)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0351)
Santiago, Region M. de Santiago, Chile
Bradford Hill Norte ( Site 0357)
Antofagasta, , Chile
Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408)
Hefei, Anhui, China
Peking University First Hospital-Urology ( Site 0390)
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University ( Site 0396)
Beijing, Beijing Municipality, China
Beijing Cancer hospital-Urinary Surgery ( Site 0395)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University ( Site 0427)
Chongqing, Chongqing Municipality, China
Chongqing University Cancer Hospital ( Site 0416)
Chongqing, Chongqing Municipality, China
Southwest Hospital of Third Military Medical University ( Site 0420)
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital's ( Site 0426)
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University-Urology ( Site 0415)
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 0412)
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413)
Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0407)
Wuhan, Hubei, China
Hubei Cancer Hospital-Urinary surgery ( Site 0406)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0405)
Changsha, Hunan, China
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436)
Huaian, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377)
Nanjing, Jiangsu, China
Affiliated hospital of Jiangnan university ( Site 0434)
Wuxi, Jiangsu, China
Jiangxi Cancer Hospital ( Site 0386)
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394)
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393)
Xi'an, Shaanxi, China
Yantai Yuhuangding Hospital ( Site 0397)
Yantai, Shandong, China
Zhongshan Hospital of Fudan University (0430)
Shanghai, Shangai, China
Fudan University Shanghai Cancer Center-Urology department ( Site 0376)
Shanghai, Shanghai Municipality, China
Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388)
Shanghai, Shanghai Municipality, China
The Third People's Hospital of Chengdu (CDTPH) ( Site 0428)
Chengdu, Sichuan, China
West China Hospital, Sichuan University-Urology Surgery ( Site 0417)
Chengdu, Sichuan, China
Nanchong Central Hospital-urology ( Site 0422)
Nanchong, Sichuan, China
Suining Central Hospital ( Site 0437)
Suining, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0392)
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University ( Site 0391)
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419)
Ürümqi, Xinjiang, China
The Second Affiliated Hospital Of Kunming Medical University ( Site 0429)
Kunming, Yunnan, China
Yunnan Province Cancer Hospital ( Site 0418)
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital-Urology ( Site 0378)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0435)
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing-urology ( Site 0380)
Jiaxing, Zhejiang, China
The First Affiliated Hospital of Ningbo University ( Site 0383)
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379)
Wenzhou, Zhejiang, China
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502)
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 0504)
Montería, Departamento de Córdoba, Colombia
Fundación Cardiovascular de Colombia ( Site 0503)
Piedecuesta, Santander Department, Colombia
Fundación Valle del Lili ( Site 0505)
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0509)
Cali, Valle del Cauca Department, Colombia
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554)
Ostrava, Moravskoslezský kraj, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555)
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551)
Prague, Praha 5, Czechia
Rigshospitalet ( Site 0576)
Copenhagen, Capital Region, Denmark
Odense Universitetshospital-Department of oncology ( Site 0579)
Odense, Region Syddanmark, Denmark
Vejle Sygehus ( Site 0578)
Vejle, Region Syddanmark, Denmark
Kuopion Yliopistollinen Sairaala ( Site 0603)
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala ( Site 0604)
Tampere, Pirkanmaa, Finland
Turku University Hospital-Department of Oncology ( Site 0601)
Turku, Southwest Finland, Finland
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627)
Strasbourg, Alsace, France
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630)
Nîmes, Gard, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632)
Rennes, Ille-et-Vilaine, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629)
Clermont-Ferrand, Puy-de-Dome, France
Centre Hospitalier de la Côte Basque ( Site 0633)
Bayonne, Pyrenees-Atlantiques, France
Gustave Roussy ( Site 0626)
Villejuif, Val-de-Marne, France
Hôpital Européen Georges Pompidou ( Site 0628)
Paris, , France
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696)
Munich, Bavaria, Germany
HELIOS Kliniken Schwerin ( Site 0694)
Schwerin, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680)
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678)
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691)
Lübeck, Schleswig-Holstein, Germany
Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682)
Jena, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679)
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705)
Hamburg, , Germany
Queen Mary Hospital ( Site 0727)
Hong Kong, , Hong Kong
Prince of Wales Hospital ( Site 0730)
Shatin, , Hong Kong
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752)
Kecskemét, Bács-Kiskun county, Hungary
Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761)
Salgótarján, Nógrád megye, Hungary
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756)
Budapest, Pest County, Hungary
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758)
Debrecen, , Hungary
St. Vincent's University Hospital ( Site 0802)
Dublin, Dublin, Ireland
Tallaght University Hospital ( Site 0801)
Dublin, , Ireland
Emek Medical Center ( Site 0830)
Afula, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0826)
Haifa, , Israel
Hadassah Medical Center ( Site 0833)
Jerusalem, , Israel
Meir Medical Center. ( Site 0832)
Kfar Saba, , Israel
Rabin Medical Center ( Site 0828)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0827)
Ramat Gan, , Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879)
Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877)
Milan, Lombardy, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0876)
Milan, , Italy
Toho University Sakura Medical Center ( Site 0906)
Sakura, Chiba, Japan
Ehime University Hospital ( Site 0918)
Tōon, Ehime, Japan
Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921)
Kitakyushu, Fukuoka, Japan
Kurume University Hospital ( Site 0920)
Kurume, Fukuoka, Japan
Asahikawa Medical University Hospital ( Site 0901)
Asahikawa, Hokkaido, Japan
Sapporo Medical University Hospital ( Site 0902)
Sapporo, Hokkaido, Japan
Hokkaido University Hospital ( Site 0931)
Sapporo, Hokkaido, Japan
Kobe University Hospital ( Site 0914)
Kobe, Hyōgo, Japan
Kanazawa Medical University Hospital ( Site 0909)
Mukai-awagasaki, Ishikawa-ken, Japan
Kagawa University Hospital ( Site 0917)
Kita, Kagawa-ken, Japan
Yokohama City University Medical Center ( Site 0908)
Yokohama, Kanagawa, Japan
National Hospital Organization Nagasaki Medical Center ( Site 0923)
Ōmura, Nagasaki, Japan
Nara Medical University Hospital ( Site 0915)
Kashihara, Nara, Japan
Nanbu Tokushukai Hospital ( Site 0930)
Shimajiri, Okinawa, Japan
Kansai Medical University Hospital ( Site 0912)
Hirakata, Osaka, Japan
Bell Land General Hospital ( Site 0913)
Sakai, Osaka, Japan
The University of Osaka Hospital ( Site 0911)
Suita, Osaka, Japan
Saga-Ken Medical Centre Koseikan ( Site 0922)
Saga, Saga-ken, Japan
The Jikei University Hospital ( Site 0907)
Minato, Tokyo, Japan
Akita University Hospital ( Site 0904)
Akita, , Japan
Kyushu University Hospital ( Site 0919)
Fukuoka, , Japan
Fukushima Medical University Hospital ( Site 0933)
Fukushima, , Japan
Gifu University Hospital ( Site 0910)
Gifu, , Japan
Hiroshima University Hospital ( Site 0916)
Hiroshima, , Japan
Kagoshima University Hospital ( Site 0929)
Kagoshima, , Japan
National Hospital Organization Kumamoto Medical Center ( Site 0924)
Kumamoto, , Japan
Miyazaki Prefectural Miyazaki Hospital ( Site 0927)
Miyazaki, , Japan
University of Miyazaki Hospital ( Site 0926)
Miyazaki, , Japan
Nagano Municipal Hospital ( Site 0932)
Nagano, , Japan
National Hospital Organization Oita Medical Center ( Site 0925)
Ōita, , Japan
Hospital Sultan Ismail ( Site 1081)
Johor Bahru, Johor, Malaysia
University Malaya Medical Centre ( Site 1077)
Lembah Pantai, Kuala Lumpur, Malaysia
National Cancer Institute ( Site 1079)
Putrajaya, Putrajaya, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 1076)
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078)
Kuala Lumpur, , Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103)
Guadalajara, Jalisco, Mexico
Quemex Medical and Research ( Site 1112)
Mexico City, Mexico City, Mexico
Filios Alta Medicina ( Site 1106)
Monterrey, Nuevo León, Mexico
Medical Care and Research SA de CV ( Site 1108)
Mérida, Yucatán, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 1109)
Oaxaca City, , Mexico
Radboudumc-Medical Oncology ( Site 1152)
Nijmegen, Gelderland, Netherlands
Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163)
Sittard-Geleen, Limburg, Netherlands
VieCuri Medisch Centrum ( Site 1173)
Venlo, Limburg, Netherlands
ETZ Elisabeth-Internal Medicine ( Site 1160)
Tilburg, North Brabant, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153)
Amsterdam, North Holland, Netherlands
Amsterdam UMC, locatie VUmc ( Site 1156)
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170)
Hoofddorp, North Holland, Netherlands
Medische Centrum Leeuwarden ( Site 1172)
Leeuwarden, Provincie Friesland, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151)
Schiedam, South Holland, Netherlands
Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164)
The Hague, South Holland, Netherlands
Meander Medisch Centrum ( Site 1157)
Amersfoort, Utrecht, Netherlands
Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201)
Tauranga, Bay of Plenty, New Zealand
Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203)
Dunedin, Otago, New Zealand
Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227)
Lørenskog, Akershus, Norway
St. Olavs Hospital-Kreftklinikken ( Site 1231)
Trondheim, Sor-Trondelag, Norway
Sykehuset Østfold Kalnes ( Site 1228)
Sarpsborg, Østfold fylke, Norway
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258)
Concepción, Departamento de Junín, Peru
Clínica Sánchez Ferrer ( Site 1261)
Trujillo, La Libertad, Peru
Aliada-Oncologìa ( Site 1257)
Lima, , Peru
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254)
Lima, , Peru
Oncosalud-Clinical Research ( Site 1260)
Lima, , Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256)
Lima, , Peru
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316)
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304)
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)
Siedlce, Masovian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)
Koszalin, West Pomeranian Voivodeship, Poland
Zachodniopomorskie Centrum Onkologii ( Site 1311)
Szczecin, West Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318)
Kielce, Świętokrzyskie Voivodeship, Poland
Puerto Rico Medical Research Center LLC ( Site 1354)
Hato Rey, , Puerto Rico
Ad-Vance Medical Research-Research ( Site 1353)
Ponce, , Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 1351)
San Juan, , Puerto Rico
National University Hospital ( Site 1376)
Singapore, Central Singapore, Singapore
National Cancer Centre Singapore ( Site 1377)
Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital-Medical Oncology ( Site 1378)
Singapore, Central Singapore, Singapore
Asan Medical Center-Oncology ( Site 1402)
Songpagu, Seoul, South Korea
Seoul National University Hospital-Oncology ( Site 1401)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404)
Seoul, , South Korea
Samsung Medical Center ( Site 1405)
Seoul, , South Korea
Hospital Jerez de la Frontera ( Site 1427)
Jerez de la Frontera, Cadiz, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433)
Madrid, Madrid, Comunidad de, Spain
Complexo Hospitalario Universitario de Ourense ( Site 1426)
Ourense, Orense, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430)
Valencia, Valenciana, Comunitat, Spain
Hospital Lucus Augusti-Oncology ( Site 1432)
Lugo, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428)
Seville, , Spain
Karolinska Universitetssjukhuset Solna ( Site 1478)
Stockholm, Stockholm County, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477)
Uppsala, Uppsala County, Sweden
Sahlgrenska Universitetssjukhuset ( Site 1479)
Gothenburg, Västra Götaland County, Sweden
China Medical University Hospital-Department of Urology ( Site 1503)
Taichung, , Taiwan
National Cheng Kung University Hospital-Urology ( Site 1502)
Tainan, , Taiwan
National Taiwan University Hospital-Urology ( Site 1506)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1505)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504)
Taoyuan District, , Taiwan
Chulalongkorn University ( Site 1530)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1531)
Bangkok, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 1526)
Muang, Changwat Khon Kaen, Thailand
Songklanagarind hospital ( Site 1527)
Hat Yai, Changwat Songkhla, Thailand
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554)
Adana, , Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi ( Site 1558)
Ankara, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551)
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 1557)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553)
Istanbul, , Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology (1560)
Samsun, , Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1605)
Cambridge, Cambridgeshire, United Kingdom
The Royal Cornwall Hospital ( Site 1610)
Truro, England, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1603)
Glasgow, Glasgow City, United Kingdom
Charing Cross Hospital-Oncology Research ( Site 1606)
London, Hammersmith and Fulham, United Kingdom
University College London Hospital ( Site 1612)
London, London, City of, United Kingdom
The Christie NHS Foundation Trust ( Site 1608)
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Jianming Guo
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Dilek Erdem
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-504899-25-00
Identifier Type: OTHER
Identifier Source: secondary_id
MK-5684-003
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031240029
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1287-5304
Identifier Type: REGISTRY
Identifier Source: secondary_id
5684-003
Identifier Type: -
Identifier Source: org_study_id