Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2025 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT03834506
Other Study ID Numbers:
3475-921
First Submitted
February 5, 2019
First Posted
February 7, 2019
Results First Posted
May 22, 2023
Last Update Posted
July 17, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and placebo treatment will be stopping. Participants who are deemed to be deriving clinical benefit from treatment may continue at the discretion of the investigator.

The global study for MK-3475-921 enrolled 1030 participants. Of the 1030 total participants enrolled in the global study, 21 were also enrolled in the China extension study for MK-3475-921 (NCT04907227).

Condition or DiseaseIntervention/Treatment
Prostatic Neoplasms
Biological: PembrolizumabDrug: Docetaxel

Study Design

Study TypeInterventional
Actual Enrollment1030 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
Study Start DateMay 1, 2019
Actual Primary Completion DateJune 19, 2022
Actual Study Completion DateJuly 17, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Pembrolizumab+Docetaxel
Participants receive pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
Biological: Pembrolizumab
IV infusion
Placebo+Docetaxel
Participants receive placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
Drug: Docetaxel
IV infusion

Outcome Measures

Primary Outcome Measures
  1. Overall Survival (OS)
    OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit Kaplan-Meier (K-M) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
  2. Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Radiological progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit K-M method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
Secondary Outcome Measures
  1. Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
    TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit K-M method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.
  2. Prostate-specific Antigen (PSA) Response Rate
    The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.
  3. Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable \[NE\], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
  4. Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    DOR was the time from first documented evidence of complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease \[NED\] on bone scan per PCWG) or partial response (PR: ≥30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable \[NE\], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG) until progressive disease (PD) or death. PD per RECIST 1.1 was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare and were persistent for ≥6 weeks. The DOR was calculated using the product-limit K-M method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
  5. Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm (AQA) Score
    TTPP was the time from randomization to pain progression (PP) based on BPI-SF Item 3 and AQA score. BPI-SF assesses pain intensity; for item 3, participant responses to "Please rate your pain at its worst in the last 24 hours" are scored from 0 (no pain) to 10 (worst pain). A higher score indicates greater pain. AQA captures the intensity of analgesic use in pain management, scored from 0 (no analgesic) to 7 (strong opioid use). A higher score indicates higher intensity of analgesic use. For participants asymptomatic at baseline, PP was ≥2-point change from baseline in BPI-SF item 3 score OR initiation of opioid use. For participants symptomatic at baseline, PP was ≥2-point change from baseline in the BPI-SF Item 3 score, a score of ≥4 and no decrease in average opioid use OR any increase in opioid use (e.g., 1 point change in AQA score). TTPP was assessed by product-limit K-M method. Participants with \>2 consecutive unevaluable visits were censored at the last evaluable assessment.
  6. Time to First Symptomatic Skeletal-related Event (SSRE)
    SSRE was the time from randomization to the first symptomatic skeletal-related event defined as: 1. Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. Occurrence of spinal cord compression 4. Tumor-related orthopedic surgical intervention, whichever occurs first. The SSRE was calculated using the product-limit K-M method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
  7. Time to Prostate-specific Antigen (PSA) Progression
    The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of: 1. ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2. ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline Time to PSA progression was calculated using the product-limit K-M method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
  8. Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit K-M method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
  9. Number of Participants Who Experienced an Adverse Event (AE)
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
  10. Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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 prior to 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 received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<2.0 nM)
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Exclusion Criteria
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has hypersensitivity to docetaxel or polysorbate 80
Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has received a live vaccine within 30 days prior to randomization
Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
Has received prior treatment with ketoconazole for prostate cancer
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
University of South Alabama, Mitchell Cancer Institute ( Site 0065) | Mobile Alabama, United States, 36604St. Joseph Heritage Healthcare ( Site 0069) | Fullerton California, United States, 92835University of Southern California Norris Comprehensive Cancer Center ( Site 0061) | Los Angeles California, United States, 90033USC Norris Oncology Hematology Newport Beach ( Site 0093) | Newport Beach California, United States, 92663University of California San Francisco ( Site 0023) | San Francisco California, United States, 94158University of Colorado Cancer Center ( Site 0022) | Aurora Colorado, United States, 80045Yale Cancer Center ( Site 0038) | New Haven Connecticut, United States, 06510Moffitt Cancer Center ( Site 0080) | Tampa Florida, United States, 33612Georgia Cancer Center at Augusta University ( Site 0026) | Augusta Georgia, United States, 30912Mount Sinai Hospital Medical Center ( Site 0042) | Chicago Illinois, United States, 60608Methodist Hospital- Merriillville ( Site 0008) | Merrillville Indiana, United States, 46410Karmanos Cancer Institute ( Site 0077) | Detroit Michigan, United States, 48201Henry Ford Health System ( Site 0039) | Detroit Michigan, United States, 48202-2608Cancer & Hematology Centers of Western Michigan ( Site 0013) | Grand Rapids Michigan, United States, 49503Washington University School of Medicine ( Site 0057) | St Louis Missouri, United States, 63110St. Vincent Frontier Cancer Center ( Site 0016) | Billings Montana, United States, 59102Nebraska Cancer Specialists ( Site 0034) | Omaha Nebraska, United States, 68130Comprehensive Cancer Centers of Nevada ( Site 0092) | Las Vegas Nevada, United States, 89169John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004) | Hackensack New Jersey, United States, 07601Associated Medical Professionals of NY ( Site 0060) | Syracuse New York, United States, 13210Duke Cancer Center ( Site 0010) | Durham North Carolina, United States, 27710W. G. Bill Hefner VA Medical Center ( Site 0029) | Salisbury North Carolina, United States, 28144University Hospitals Cleveland Medical Center ( Site 0036) | Cleveland Ohio, United States, 44106Oregon Health Sciences University ( Site 0031) | Portland Oregon, United States, 97239Carolina Urologic Research Center ( Site 0070) | Myrtle Beach South Carolina, United States, 29572Inova Schar Cancer Institute ( Site 0006) | Fairfax Virginia, United States, 22031-4867Virginia Cancer Institute ( Site 0052) | Richmond Virginia, United States, 23230Blue Ridge Cancer Care ( Site 0086) | Roanoke Virginia, United States, 24014Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013) | Berazategui Buenos Aires, Argentina, B1884BBFInstituto de Investigaciones Clinicas ( Site 1000) | Mar del Plata Buenos Aires, Argentina, B7600FZNCentro de Diagnostico Urologico ( Site 1008) | Buenos Aires Buenos Aires F.D., Argentina, C1120AATHospital Britanico de Buenos Aires ( Site 1006) | Buenos Aires Buenos Aires F.D., Argentina, C1280AEBSanatorio Parque ( Site 1002) | Rosario Santa Fe Province, Argentina, S2000DSVInstituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011) | Buenos Aires , Argentina, C1012AARHospital Aleman ( Site 1004) | Buenos Aires , Argentina, C1118AATInstituto Medico Alexander Fleming ( Site 1010) | Buenos Aires , Argentina, C1426ANZCEMAIC ( Site 1014) | Córdoba , Argentina, X5008HHWSt George Hospital ( Site 0157) | Kogarah New South Wales, Australia, 2217Macquarie University ( Site 0151) | Macquarie University New South Wales, Australia, 2109Port Macquarie Base Hospital ( Site 0153) | Port Macquarie New South Wales, Australia, 2444Calvary Mater Newcastle ( Site 0148) | Waratah New South Wales, Australia, 2298Redcliffe Hospital ( Site 0161) | Redcliffe Queensland, Australia, 4020John Flynn Hospital & Medical Centre ( Site 0164) | Tugun Queensland, Australia, 4224Hollywood Private Hospital ( Site 0163) | Nedlands Western Australia, Australia, 6009Medizinische Universitat Graz ( Site 0374) | Graz Styria, Austria, 8036Ordensklinikum Linz GmbH Elisabethinen ( Site 0373) | Linz Upper Austria, Austria, 4020SCRI-CCCIT GesmbH ( Site 0371) | Salzburg , Austria, 5020Medizinische Universitaet Wien ( Site 0375) | Vienna , Austria, 1090Hospital de Caridade de Ijui ( Site 1038) | Ijuí Rio Grande do Sul, Brazil, 98700-000Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021) | Porto Alegre Rio Grande do Sul, Brazil, 90610-000Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035) | Itajaí Santa Catarina, Brazil, 88301-215Hospital de Base de Sao Jose de Rio Preto ( Site 1022) | São José do Rio Preto São Paulo, Brazil, 15090-000A.C. Camargo Cancer Center ( Site 1026) | São Paulo , Brazil, 01509-900Nova Scotia Health Authority QEII-HSC ( Site 0114) | Halifax Nova Scotia, Canada, B3H 2Y9Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116) | Hamilton Ontario, Canada, L8V5C2Grand River Hospital ( Site 0120) | Kitchener Ontario, Canada, N2G 1G3Lakeridge Health ( Site 0117) | Oshawa Ontario, Canada, L1G 2B9Sunnybrook Research Institute ( Site 0108) | Toronto Ontario, Canada, M4N 3M5Princess Margaret Cancer Centre ( Site 0107) | Toronto Ontario, Canada, M5G 2M9CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103) | Québec Quebec, Canada, G1R 2J6CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102) | Rimouski Quebec, Canada, G5L 5T1CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105) | Sherbrooke Quebec, Canada, J1H 5N4Centro Investigación del Cáncer James Lind ( Site 1041) | Temuco Araucania, Chile, 4780000Rey y Oreilly Limitada ( Site 1048) | Temuco Araucania, Chile, 4810148Fundacion Arturo Lopez Perez ( Site 1049) | Santiago Region M. de Santiago, Chile, 7500921Pontificia Universidad Catolica de Chile ( Site 1047) | Santiago Region M. de Santiago, Chile, 8330032Bradford Hill Centro de Investigaciones Clinicas ( Site 1044) | Santiago Region M. de Santiago, Chile, 8420383Centro de Investigaciones Clinicas Vina del Mar ( Site 1042) | Viña del Mar Valparaiso, Chile, 2540488Peking University First Hospital ( Site 1303) | Beijing Beijing Municipality, China, 100034The Fifth Medical Center of PLA General Hospital ( Site 1307) | Beijing Beijing Municipality, China, 100071Beijing Cancer Hospital ( Site 1305) | Beijing Beijing Municipality, China, 100142The First Affiliated Hospital of Xiamen University ( Site 1319) | Xiamen Fujian, China, 361003Sun Yat Sen Memorial Hospital ( Site 1323) | Guangzhou Guangdong, China, 510220The First Affiliated Hospital of Guangzhou Medical University ( Site 1330) | Guangzhou Guangdong, China, 510230Harbin Medical University Cancer Hospital ( Site 1326) | Harbin Heilongjiang, China, 150081Henan Cancer Hospital ( Site 1321) | Zhengzhou Henan, China, 450008Hubei Cancer Hospital ( Site 1329) | Wuhan Hubei, China, 430079Hunan Cancer Hospital ( Site 1320) | Changsha Hunan, China, 410013Nanjing Drum Tower Hospital ( Site 1312) | Nanjing Jiangsu, China, 210008Fudan University Shanghai Cancer Center ( Site 1300) | Shanghai Shanghai Municipality, China, 200032Zhongshan Hospital Fudan University ( Site 1301) | Shanghai Shanghai Municipality, China, 200032The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309) | Hangzhou Zhejiang, China, 310009Zhejiang Provincial People's Hospital ( Site 1310) | Hangzhou Zhejiang, China, 310014Hospital Pablo Tobon Uribe ( Site 1066) | Medellín Antioquia, Colombia, 050034Biomelab S A S ( Site 1067) | Barranquilla Atlántico, Colombia, 080002Clinica de la Costa Ltda. ( Site 1073) | Barranquilla Atlántico, Colombia, 080020Instituto Nacional de Cancerologia E.S.E ( Site 1061) | Bogotá Bogota D.C., Colombia, 110321Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062) | Bogotá Bogota D.C., Colombia, 111321Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068) | Valledupar Cesar Department, Colombia, 200001Oncomedica S.A. ( Site 1057) | Montería Departamento de Córdoba, Colombia, 230002Oncologos del Occidente S.A. ( Site 1072) | Pereira Risaralda Department, Colombia, 660001Centro Medico Imbanaco de Cali S.A ( Site 1064) | Cali Valle del Cauca Department, Colombia, 760042Hemato Oncologos S.A. ( Site 1065) | Cali Valle del Cauca Department, Colombia, 760042C.H. de Saint Quentin ( Site 0481) | Saint-Quentin Aisne, France, 02321Clinique Sainte Anne ( Site 0431) | Strasbourg Alsace, France, 67000Centre Jean Perrin ( Site 0434) | Clermont-Ferrand Auvergne, France, 63011Centre Leon Berard ( Site 0422) | Lyon Auvergne, France, 69373Institut Paoli Calmettes. ( Site 0419) | Marseille Bouches-du-Rhone, France, 13009CHU Jean Minjoz ( Site 0423) | Besançon Doubs, France, 25000CHU de Brest -Site Hopital Morvan ( Site 0441) | Brest Finistere, France, 29200Institut Bergonie ( Site 0421) | Bordeaux Gironde, France, 33076Institut Claudius Regaud IUCT Oncopole ( Site 0418) | Toulouse Haute-Garonne, France, 31059Hopital Foch ( Site 0428) | Suresnes Hauts-de-Seine, France, 92151Institut De Cancerologie De L Ouest ( Site 0448) | Saint-Herblain Loire-Atlantique, France, 44805Centre Hospitalier Regional du Orleans ( Site 0430) | Orléans Loiret, France, 45100Centre D Oncologie de Gentilly ( Site 0432) | Nancy Meurthe-et-Moselle, France, 54100C.H.U. Lyon Sud ( Site 0436) | Pierre-Bénite Rhone, France, 69310CHU Amiens Picardie Site Sud Amiens ( Site 0438) | Amiens Somme, France, 80000Institut Gustave Roussy ( Site 0416) | Villejuif Val-de-Marne, France, 94800Institut Sainte Catherine ( Site 0447) | Avignon Vaucluse, France, 84000Institut Mutualiste Montsouris ( Site 0446) | Paris , France, 75014Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304) | Freiburg im Breisgau Baden-Wurttemberg, Germany, 79106Universitaetsklinikum in Mannheim ( Site 0314) | Mannheim Baden-Wurttemberg, Germany, 68167Studienpraxis Urologie ( Site 0309) | Nürtingen Baden-Wurttemberg, Germany, 72622Universitaetsklinik fuer Urologie ( Site 0307) | Tübingen Baden-Wurttemberg, Germany, 72076Klinikum Rechts der Isar ( Site 0300) | Munich Bavaria, Germany, 81675Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318) | Nuremberg Bavaria, Germany, 90419Universitaetsklinikum Wuerzburg ( Site 0302) | Würzburg Bavaria, Germany, 97080Universitaetsklinikum Goettingen ( Site 0345) | Göttingen Lower Saxony, Germany, 37075Uniklinik RWTH Aachen ( Site 0308) | Aachen North Rhine-Westphalia, Germany, 52074Universitaetsklinikum des Saarlandes ( Site 0348) | Homburg Saarland, Germany, 66421Universitaetsklinikum Jena ( Site 0305) | Jena Thuringia, Germany, 07747Charite Universitaetsmedizin Berlin ( Site 0301) | Berlin , Germany, 10117Cork University Hospital ( Site 0727) | Cork , Ireland, T12 YE02Tallaght University Hospital ( Site 0730) | Dublin , Ireland, D24 NROAMid Western Cancer Centre ( Site 0728) | Limerick , Ireland, Assaf Harofeh MC ( Site 0547) | Beer Yaakov-Zerifin , Israel, 7030001Soroka Medical Center ( Site 0548) | Beersheba , Israel, 8410101Rambam Medical Center ( Site 0543) | Haifa , Israel, 3109601Hadassah Ein Kerem Medical Center ( Site 0546) | Jerusalem , Israel, 9112001Meir Medical Center ( Site 0544) | Kfar Saba , Israel, 4428164Rabin Medical Center ( Site 0545) | Petah Tikva , Israel, 4941492Chaim Sheba Medical Center ( Site 0541) | Ramat Gan , Israel, 5262000Sourasky Medical Center ( Site 0542) | Tel Aviv , Israel, 6423906Istituto Clinico Humanitas Research Hospital ( Site 0452) | Rozzano Milano, Italy, 20089Azienda Ospedaliera Cannizzaro ( Site 0458) | Catania , Italy, 95126A.O. Universitaria di Modena ( Site 0454) | Modena , Italy, 41100Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457) | Naples , Italy, 80131Azienda Ospedaliera San Camillo Forlanini ( Site 0455) | Roma , Italy, 00152Azienda Ospedaliera Santa Maria Terni ( Site 0456) | Terni , Italy, 05100Presidio Ospedaliero Santa Chiara ( Site 0451) | Trento , Italy, 38122National Cancer Center Hospital East ( Site 0702) | Kashiwa Chiba, Japan, 277-8577Toho University Sakura Medical Center ( Site 0703) | Sakura Chiba, Japan, 285-8741National Hospital Organization Shikoku Cancer Center ( Site 0716) | Matsuyama Ehime, Japan, 791-0280Kanazawa University Hospital ( Site 0701) | Kanazawa Ishikawa-ken, Japan, 920-8641Kitasato University Hospital ( Site 0705) | Sagamihara Kanagawa, Japan, 252-0375Yokohama City University Medical Center ( Site 0706) | Yokohama Kanagawa, Japan, 232-0024Nara Medical University Hospital ( Site 0715) | Kashihara Nara, Japan, 634-8522Kindai University Hospital ( Site 0714) | Sayama Osaka, Japan, 589-8511Osaka University Hospital ( Site 0713) | Suita Osaka, Japan, 565-0871Saitama Medical University International Medical Center ( Site 0708) | Hidaka Saitama, Japan, 1932Dokkyo Medical University Saitama Medical Center ( Site 0707) | Koshigaya Saitama, Japan, 343-8555Hamamatsu University Hospital ( Site 0720) | Hamamatsu Shizuoka, Japan, 431-3192Yamaguchi University Hospital ( Site 0717) | Ube Yamaguchi, Japan, 755-8505Chiba Cancer Center ( Site 0704) | Chiba , Japan, 260-8717Kyushu University Hospital ( Site 0718) | Fukuoka , Japan, 812-8582University of Miyazaki Hospital ( Site 0721) | Miyazaki , Japan, 889-1692Nagasaki University Hospital ( Site 0719) | Nagasaki , Japan, 852-8501Toranomon Hospital ( Site 0711) | Tokyo , Japan, 105-8470Nippon Medical School Hospital ( Site 0709) | Tokyo , Japan, 113-8603Keio University Hospital ( Site 0710) | Tokyo , Japan, 160-8582Ziekenhuis Gelderse Vallei ( Site 0485) | Ede Gelderland, Netherlands, 6746 RPRadboud University Medical Center ( Site 0470) | Nijmegen Gelderland, Netherlands, 6525 GAVieCuri Medisch Centrum ( Site 0487) | Venlo Limburg, Netherlands, 5912 BLJeroen Bosch Ziekenhuis ( Site 1200) | 's-Hertogenbosch North Brabant, Netherlands, 5223 GZCatharina Ziekenhuis ( Site 0472) | Eindhoven North Brabant, Netherlands, 5623 EJAntoni van Leeuwenhoek Ziekenhuis ( Site 0480) | Amsterdam North Holland, Netherlands, 1066 CXZiekenhuis Hilversum ( Site 0466) | Hilversum North Holland, Netherlands, 1213 XZZiekenhuisgroep Twente ( Site 0469) | Hengelo Overijssel, Netherlands, 7555 DLMedisch Centrum Leeuwarden ( Site 0477) | Leeuwarden Provincie Friesland, Netherlands, 8934 ADReinier de Graaf Groep ( Site 0484) | Delft South Holland, Netherlands, 2625 ADHagaziekenhuis ( Site 1201) | The Hague South Holland, Netherlands, 2545 AAChelyabinsk Regional Clinical Oncological Dispensary ( Site 0565) | Chelyabinsk Chelyabinsk Oblast, Russia, 454087Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585) | Krasnoyarsk Krasnoyarsk Krai, Russia, 660133SBIH City clinical hospital named after D.D. Pletniov ( Site 0575) | Moscow Moscow, Russia, 105077Russian Scientific Center of Radiology ( Site 0559) | Moscow Moscow, Russia, 117485Central Clinical Hospital with Polyclinic ( Site 0562) | Moscow Moscow, Russia, 121359National Medical Research Radiological Center ( Site 0556) | Moscow Moscow, Russia, 125284Volga District Medical Center Federal Medical and Biological Agency ( Site 0572) | Nizhny Novgorod Nizhny Novgorod Oblast, Russia, 603074Omsk Clinical Oncology Dispensary ( Site 0568) | Omsk Omsk Oblast, Russia, 644013SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) | Samara Samara Oblast, Russia, 443031Leningrad Regional Oncology Center ( Site 0588) | Saint Petersburg Sankt-Peterburg, Russia, 188663Clinical Research Center of specialized types medical care-Oncology ( Site 0570) | Saint Petersburg Sankt-Peterburg, Russia, 197758Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567) | Saint Petersburg Sankt-Peterburg, Russia, 197758SPb SBHI City Clinical Oncological Dispensary ( Site 0571) | Saint Petersburg Sankt-Peterburg, Russia, 198255Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579) | Tomsk Tomsk Oblast, Russia, 634050National Cancer Center ( Site 0174) | Goyang-si Kyonggi-do, South Korea, 10408Seoul National University Bundang Hospital ( Site 0175) | Seongnam-si Kyonggi-do, South Korea, 13620Seoul National University Hospital ( Site 0171) | Seoul , South Korea, 03080Asan Medical Center ( Site 0176) | Seoul , South Korea, 05505Samsung Medical Center ( Site 0172) | Seoul , South Korea, 06351Instituto Catalan de Oncologia - ICO ( Site 0330) | L'Hospitalet de Llobregat Barcelona, Spain, 08908Hospital Consorci Sanitari Parc Tauli ( Site 0335) | Sabadell Barcelona, Spain, 08208Hospital Universitario Marques de Valdecilla ( Site 0336) | Santander Cantabria, Spain, 39008Hospital Josep Trueta ( Site 0321) | Girona Gerona, Spain, 17007Hospital del Mar ( Site 0333) | Barcelona , Spain, 08003Hospital Clinic ( Site 0323) | Barcelona , Spain, 08036Hospital Universitario Ramon y Cajal ( Site 0328) | Madrid , Spain, 28034Hospital Clinico San Carlos ( Site 0324) | Madrid , Spain, 28040Hospital Universitario HM Sanchinarro ( Site 0322) | Madrid , Spain, 28050Hospital Universitario Virgen de la Victoria ( Site 0337) | Málaga , Spain, 29016Hospital Virgen del Rocio ( Site 0329) | Seville , Spain, 41013National Cheng Kung University Hospital ( Site 0134) | Tainen Tainan, Taiwan, 704China Medical University Hospital ( Site 0132) | Taichung , Taiwan, 40447Taichung Veterans General Hospital ( Site 0133) | Taichung , Taiwan, 40705National Taiwan University Hospital ( Site 0131) | Taipei , Taiwan, 10048Taipei Veterans General Hospital ( Site 0135) | Taipei , Taiwan, 11217University Hospitals Bristol NHS Foundation Trust ( Site 0530) | Bristol Bristol, City of, United Kingdom, BS2 8EDCambridge University Hospitals NHS Trust ( Site 0540) | Cambridge Cambridgeshire, United Kingdom, CB2 0QQTorbay Hospital ( Site 0532) | Torquay Devon, United Kingdom, TQ2 7AAWeston Park Hospital ( Site 0539) | Sheffield England, United Kingdom, S10 2SJRoyal Marsden Hospital ( Site 0526) | Sutton England, United Kingdom, SM2 5PTMount Vernon Cancer Centre ( Site 0536) | Northwood Hertfordshire, United Kingdom, HA6 2RNBarts Cancer Institute ( Site 0483) | London London, City of, United Kingdom, EC1A 7BEUniversity of North Midlands NHS Foundation Trust ( Site 0527) | Stoke-on-Trent Staffordshire, United Kingdom, ST4 6QG
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full Text)
Documents provided by Merck Sharp & Dohme LLC: Study Protocol and Statistical Analysis Plan  September 28, 2022