Back to resultsStudy of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Docetaxel
Prednisone
Placebo
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Programmed Cell Death 1 (PD 1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL 1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL 2, PD-L2)
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 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
Sites / Locations
- University of South Alabama, Mitchell Cancer Institute ( Site 0065)
- St. Joseph Heritage Healthcare ( Site 0069)
- University of Southern California Norris Comprehensive Cancer Center ( Site 0061)
- USC Norris Oncology Hematology Newport Beach ( Site 0093)
- University of California San Francisco ( Site 0023)
- University of Colorado Cancer Center ( Site 0022)
- Yale Cancer Center ( Site 0038)
- Moffitt Cancer Center ( Site 0080)
- Georgia Cancer Center at Augusta University ( Site 0026)
- Mount Sinai Hospital Medical Center ( Site 0042)
- Methodist Hospital- Merriillville ( Site 0008)
- Karmanos Cancer Institute ( Site 0077)
- Henry Ford Health System ( Site 0039)
- Cancer & Hematology Centers of Western Michigan ( Site 0013)
- Washington University School of Medicine ( Site 0057)
- St. Vincent Frontier Cancer Center ( Site 0016)
- Nebraska Cancer Specialists ( Site 0034)
- Comprehensive Cancer Centers of Nevada ( Site 0092)
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
- Associated Medical Professionals of NY ( Site 0060)
- Duke Cancer Center ( Site 0010)
- W. G. Bill Hefner VA Medical Center ( Site 0029)
- University Hospitals Cleveland Medical Center ( Site 0036)
- Oregon Health Sciences University ( Site 0031)
- Carolina Urologic Research Center ( Site 0070)
- Inova Schar Cancer Institute ( Site 0006)
- Virginia Cancer Institute ( Site 0052)
- Blue Ridge Cancer Care ( Site 0086)
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
- Instituto de Investigaciones Clinicas ( Site 1000)
- Centro de Diagnostico Urologico ( Site 1008)
- Hospital Britanico de Buenos Aires ( Site 1006)
- Sanatorio Parque ( Site 1002)
- Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
- Hospital Aleman ( Site 1004)
- Instituto Medico Alexander Fleming ( Site 1010)
- CEMAIC ( Site 1014)
- St George Hospital ( Site 0157)
- Macquarie University ( Site 0151)
- Port Macquarie Base Hospital ( Site 0153)
- Calvary Mater Newcastle ( Site 0148)
- Redcliffe Hospital ( Site 0161)
- John Flynn Hospital & Medical Centre ( Site 0164)
- Hollywood Private Hospital ( Site 0163)
- Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
- Medizinische Universitat Graz ( Site 0374)
- SCRI-CCCIT GesmbH ( Site 0371)
- Medizinische Universitaet Wien ( Site 0375)
- Hospital de Caridade de Ijui ( Site 1038)
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
- Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
- Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
- A.C. Camargo Cancer Center ( Site 1026)
- Nova Scotia Health Authority QEII-HSC ( Site 0114)
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
- Grand River Hospital ( Site 0120)
- Lakeridge Health ( Site 0117)
- Sunnybrook Research Institute ( Site 0108)
- Princess Margaret Cancer Centre ( Site 0107)
- CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
- CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
- CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103)
- Centro Investigación del Cáncer James Lind ( Site 1041)
- Rey y Oreilly Limitada ( Site 1048)
- Fundacion Arturo Lopez Perez ( Site 1049)
- Pontificia Universidad Catolica de Chile ( Site 1047)
- Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
- Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)
- Peking University First Hospital ( Site 1303)
- The Fifth Medical Center of PLA General Hospital ( Site 1307)
- Beijing Cancer Hospital ( Site 1305)
- The First Affiliated Hospital of Xiamen University ( Site 1319)
- Sun Yat Sen Memorial Hospital ( Site 1323)
- The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)
- Harbin Medical University Cancer Hospital ( Site 1326)
- Henan Cancer Hospital ( Site 1321)
- Hubei Cancer Hospital ( Site 1329)
- Hunan Cancer Hospital ( Site 1320)
- Nanjing Drum Tower Hospital ( Site 1312)
- Fudan University Shanghai Cancer Center ( Site 1300)
- Zhongshan Hospital Fudan University ( Site 1301)
- The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)
- Zhejiang Provincial People's Hospital ( Site 1310)
- Hospital Pablo Tobon Uribe ( Site 1066)
- Biomelab S A S ( Site 1067)
- Clinica de la Costa Ltda. ( Site 1073)
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
- Oncomedica S.A. ( Site 1057)
- Instituto Nacional de Cancerologia E.S.E ( Site 1061)
- Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
- Oncologos del Occidente S.A. ( Site 1072)
- Centro Medico Imbanaco de Cali S.A ( Site 1064)
- Hemato Oncologos S.A. ( Site 1065)
- C.H. de Saint Quentin ( Site 0481)
- Clinique Sainte Anne ( Site 0431)
- Centre Jean Perrin ( Site 0434)
- Centre Leon Berard ( Site 0422)
- Institut Paoli Calmettes. ( Site 0419)
- CHU Jean Minjoz ( Site 0423)
- CHU de Brest -Site Hopital Morvan ( Site 0441)
- Institut Bergonie ( Site 0421)
- Institut Claudius Regaud IUCT Oncopole ( Site 0418)
- Hopital Foch ( Site 0428)
- Institut De Cancerologie De L Ouest ( Site 0448)
- Centre Hospitalier Regional du Orleans ( Site 0430)
- Centre D Oncologie de Gentilly ( Site 0432)
- C.H.U. Lyon Sud ( Site 0436)
- CHU Amiens Picardie Site Sud Amiens ( Site 0438)
- Institut Gustave Roussy ( Site 0416)
- Institut Sainte Catherine ( Site 0447)
- Institut Mutualiste Montsouris ( Site 0446)
- Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
- Universitaetsklinikum in Mannheim ( Site 0314)
- Studienpraxis Urologie ( Site 0309)
- Universitaetsklinik fuer Urologie ( Site 0307)
- Klinikum Rechts der Isar ( Site 0300)
- Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
- Universitaetsklinikum Wuerzburg ( Site 0302)
- Universitaetsklinikum Goettingen ( Site 0345)
- Uniklinik RWTH Aachen ( Site 0308)
- Universitaetsklinikum des Saarlandes ( Site 0348)
- Universitaetsklinikum Jena ( Site 0305)
- Charite Universitaetsmedizin Berlin ( Site 0301)
- Cork University Hospital ( Site 0727)
- Tallaght University Hospital ( Site 0730)
- Mid Western Cancer Centre ( Site 0728)
- Soroka Medical Center ( Site 0548)
- Assaf Harofeh MC ( Site 0547)
- Rambam Medical Center ( Site 0543)
- Hadassah Ein Kerem Medical Center ( Site 0546)
- Meir Medical Center ( Site 0544)
- Rabin Medical Center ( Site 0545)
- Chaim Sheba Medical Center ( Site 0541)
- Sourasky Medical Center ( Site 0542)
- Istituto Clinico Humanitas Research Hospital ( Site 0452)
- Azienda Ospedaliera Cannizzaro ( Site 0458)
- A.O. Universitaria di Modena ( Site 0454)
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)
- Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
- Azienda Ospedaliera Santa Maria Terni ( Site 0456)
- Presidio Ospedaliero Santa Chiara ( Site 0451)
- National Cancer Center Hospital East ( Site 0702)
- Toho University Sakura Medical Center ( Site 0703)
- National Hospital Organization Shikoku Cancer Center ( Site 0716)
- Kanazawa University Hospital ( Site 0701)
- Kitasato University Hospital ( Site 0705)
- Yokohama City University Medical Center ( Site 0706)
- Nara Medical University Hospital ( Site 0715)
- Kindai University Hospital ( Site 0714)
- Osaka University Hospital ( Site 0713)
- Saitama Medical University International Medical Center ( Site 0708)
- Dokkyo Medical University Saitama Medical Center ( Site 0707)
- Hamamatsu University Hospital ( Site 0720)
- Yamaguchi University Hospital ( Site 0717)
- Chiba Cancer Center ( Site 0704)
- Kyushu University Hospital ( Site 0718)
- University of Miyazaki Hospital ( Site 0721)
- Nagasaki University Hospital ( Site 0719)
- Toranomon Hospital ( Site 0711)
- Nippon Medical School Hospital ( Site 0709)
- Keio University Hospital ( Site 0710)
- National Cancer Center ( Site 0174)
- Seoul National University Bundang Hospital ( Site 0175)
- Seoul National University Hospital ( Site 0171)
- Asan Medical Center ( Site 0176)
- Samsung Medical Center ( Site 0172)
- Medisch Centrum Leeuwarden ( Site 0477)
- Ziekenhuis Gelderse Vallei ( Site 0485)
- Radboud University Medical Center ( Site 0470)
- VieCuri Medisch Centrum ( Site 0487)
- Jeroen Bosch Ziekenhuis ( Site 1200)
- Catharina Ziekenhuis ( Site 0472)
- Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
- Ziekenhuis Hilversum ( Site 0466)
- Ziekenhuisgroep Twente ( Site 0469)
- Reinier de Graaf Groep ( Site 0484)
- Hagaziekenhuis ( Site 1201)
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
- SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)
- Russian Scientific Center of Radiology ( Site 0559)
- Central Clinical Hospital with Polyclinic ( Site 0562)
- National Medical Research Radiological Center ( Site 0556)
- Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)
- Omsk Clinical Oncology Dispensary ( Site 0568)
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
- Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
- Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
- SPb SBHI City Clinical Oncological Dispensary ( Site 0571)
- Leningrad Regional Oncology Center ( Site 0588)
- Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)
- Instituto Catalan de Oncologia - ICO ( Site 0330)
- Hospital Consorci Sanitari Parc Tauli ( Site 0335)
- Hospital Universitario Marques de Valdecilla ( Site 0336)
- Hospital Josep Trueta ( Site 0321)
- Hospital del Mar ( Site 0333)
- Hospital Clinic ( Site 0323)
- Hospital Universitario Ramon y Cajal ( Site 0328)
- Hospital Clinico San Carlos ( Site 0324)
- Hospital Universitario HM Sanchinarro ( Site 0322)
- Hospital Universitario Virgen de la Victoria ( Site 0337)
- Hospital Virgen del Rocio ( Site 0329)
- National Cheng Kung University Hospital ( Site 0134)
- China Medical University Hospital ( Site 0132)
- Taichung Veterans General Hospital ( Site 0133)
- National Taiwan University Hospital ( Site 0131)
- Taipei Veterans General Hospital ( Site 0135)
- University Hospitals Bristol NHS Foundation Trust ( Site 0530)
- Cambridge University Hospitals NHS Trust ( Site 0540)
- Torbay Hospital ( Site 0532)
- Weston Park Hospital ( Site 0539)
- Royal Marsden Hospital ( Site 0526)
- Mount Vernon Cancer Centre ( Site 0536)
- Barts Cancer Institute ( Site 0483)
- University of North Midlands NHS Foundation Trust ( Site 0527)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pembrolizumab+Docetaxel
Placebo+Docetaxel
Arm Description
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 Q3W for a maximum of 10 cycles (approximately 7 months). Participants also 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 docetaxel cycle.
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 Q3W for a maximum of 10 cycles (approximately 7 months). Participants also 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 docetaxel cycle.
Outcomes
Primary Outcome Measures
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) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
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. 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 (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
Secondary Outcome Measures
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 (Kaplan-Meier) 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.
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.
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
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).
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
DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate 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 (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
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 defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:
For participants asymptomatic at baseline: a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain
For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
Time to First Symptomatic Skeletal-related Event (SSRE)
SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)
Occurrence of spinal cord compression
Tumor-related orthopedic surgical intervention, whichever occurs first.
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
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:
≥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
≥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 (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
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 (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
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.
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.
Full Information
NCT ID
NCT03834506
First Posted
February 6, 2019
Last Updated
August 10, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03834506
Brief Title
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)
Official Title
A 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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
July 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Programmed Cell Death 1 (PD 1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL 1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL 2, PD-L2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1030 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab+Docetaxel
Arm Type
Experimental
Arm Description
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 Q3W for a maximum of 10 cycles (approximately 7 months). Participants also 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 docetaxel cycle.
Arm Title
Placebo+Docetaxel
Arm Type
Placebo Comparator
Arm Description
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 Q3W for a maximum of 10 cycles (approximately 7 months). Participants also 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 docetaxel cycle.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
TAXOTERE®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline or dextrose infusion
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DECADRON®
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Time Frame
Up to 36.5 months
Title
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)
Description
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. 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 (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
Time Frame
Up to approximately 28 months
Secondary Outcome Measure Information:
Title
Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
Description
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 (Kaplan-Meier) 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.
Time Frame
Up to approximately 28 months
Title
Prostate-specific Antigen (PSA) Response Rate
Description
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.
Time Frame
Up to 36.5 months
Title
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
Description
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).
Time Frame
Up to 36.5 months
Title
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
Description
DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate 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 (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
Time Frame
Up to 36.5 months
Title
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
Description
TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:
For participants asymptomatic at baseline: a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain
For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
Time Frame
Up to 36.5 months
Title
Time to First Symptomatic Skeletal-related Event (SSRE)
Description
SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)
Occurrence of spinal cord compression
Tumor-related orthopedic surgical intervention, whichever occurs first.
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
Time Frame
Up to 36.5 months
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:
≥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
≥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 (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
Time Frame
Up to 36.5 months
Title
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)
Description
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 (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
Time Frame
Up to 36.5 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 30 months
Title
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 27 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama, Mitchell Cancer Institute ( Site 0065)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
St. Joseph Heritage Healthcare ( Site 0069)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of Southern California Norris Comprehensive Cancer Center ( Site 0061)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Oncology Hematology Newport Beach ( Site 0093)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California San Francisco ( Site 0023)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 0022)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Cancer Center ( Site 0038)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Moffitt Cancer Center ( Site 0080)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Cancer Center at Augusta University ( Site 0026)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Mount Sinai Hospital Medical Center ( Site 0042)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Methodist Hospital- Merriillville ( Site 0008)
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Karmanos Cancer Institute ( Site 0077)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System ( Site 0039)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan ( Site 0013)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Washington University School of Medicine ( Site 0057)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Vincent Frontier Cancer Center ( Site 0016)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Nebraska Cancer Specialists ( Site 0034)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada ( Site 0092)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Associated Medical Professionals of NY ( Site 0060)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Cancer Center ( Site 0010)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
W. G. Bill Hefner VA Medical Center ( Site 0029)
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
University Hospitals Cleveland Medical Center ( Site 0036)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University ( Site 0031)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Carolina Urologic Research Center ( Site 0070)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Inova Schar Cancer Institute ( Site 0006)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031-4867
Country
United States
Facility Name
Virginia Cancer Institute ( Site 0052)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Blue Ridge Cancer Care ( Site 0086)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas ( Site 1000)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Centro de Diagnostico Urologico ( Site 1008)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires ( Site 1006)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Sanatorio Parque ( Site 1002)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Hospital Aleman ( Site 1004)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Instituto Medico Alexander Fleming ( Site 1010)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
CEMAIC ( Site 1014)
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
St George Hospital ( Site 0157)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Macquarie University ( Site 0151)
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Port Macquarie Base Hospital ( Site 0153)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Calvary Mater Newcastle ( Site 0148)
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Redcliffe Hospital ( Site 0161)
City
Redcliffe
State/Province
Queensland
ZIP/Postal Code
4020
Country
Australia
Facility Name
John Flynn Hospital & Medical Centre ( Site 0164)
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Hollywood Private Hospital ( Site 0163)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universitat Graz ( Site 0374)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
SCRI-CCCIT GesmbH ( Site 0371)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universitaet Wien ( Site 0375)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital de Caridade de Ijui ( Site 1038)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-215
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 1026)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Nova Scotia Health Authority QEII-HSC ( Site 0114)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
Grand River Hospital ( Site 0120)
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Lakeridge Health ( Site 0117)
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0108)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0107)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 1041)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Rey y Oreilly Limitada ( Site 1048)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810148
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez ( Site 1049)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 1047)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Peking University First Hospital ( Site 1303)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
The Fifth Medical Center of PLA General Hospital ( Site 1307)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital ( Site 1305)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 1319)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Sun Yat Sen Memorial Hospital ( Site 1323)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 1326)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 1321)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Cancer Hospital ( Site 1329)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital ( Site 1320)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing Drum Tower Hospital ( Site 1312)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 1300)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital Fudan University ( Site 1301)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Provincial People's Hospital ( Site 1310)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Hospital Pablo Tobon Uribe ( Site 1066)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Biomelab S A S ( Site 1067)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Clinica de la Costa Ltda. ( Site 1073)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 1057)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 1061)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110321
Country
Colombia
Facility Name
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Oncologos del Occidente S.A. ( Site 1072)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 1064)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Hemato Oncologos S.A. ( Site 1065)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
C.H. de Saint Quentin ( Site 0481)
City
Saint Quentin
State/Province
Aisne
ZIP/Postal Code
02321
Country
France
Facility Name
Clinique Sainte Anne ( Site 0431)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Jean Perrin ( Site 0434)
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leon Berard ( Site 0422)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes. ( Site 0419)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Facility Name
CHU Jean Minjoz ( Site 0423)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 0441)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Facility Name
Institut Bergonie ( Site 0421)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0418)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Foch ( Site 0428)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92151
Country
France
Facility Name
Institut De Cancerologie De L Ouest ( Site 0448)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Regional du Orleans ( Site 0430)
City
Orleans
State/Province
Loiret
ZIP/Postal Code
45100
Country
France
Facility Name
Centre D Oncologie de Gentilly ( Site 0432)
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
C.H.U. Lyon Sud ( Site 0436)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
CHU Amiens Picardie Site Sud Amiens ( Site 0438)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80000
Country
France
Facility Name
Institut Gustave Roussy ( Site 0416)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Institut Sainte Catherine ( Site 0447)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84000
Country
France
Facility Name
Institut Mutualiste Montsouris ( Site 0446)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum in Mannheim ( Site 0314)
City
Mannheim
State/Province
Baden-Wurttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Studienpraxis Urologie ( Site 0309)
City
Nuertingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinik fuer Urologie ( Site 0307)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum Rechts der Isar ( Site 0300)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg ( Site 0302)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Universitaetsklinikum Goettingen ( Site 0345)
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Uniklinik RWTH Aachen ( Site 0308)
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes ( Site 0348)
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitaetsklinikum Jena ( Site 0305)
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin ( Site 0301)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Cork University Hospital ( Site 0727)
City
Cork
ZIP/Postal Code
T12 YE02
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 0730)
City
Dublin
ZIP/Postal Code
D24 NROA
Country
Ireland
Facility Name
Mid Western Cancer Centre ( Site 0728)
City
Limerick
Country
Ireland
Facility Name
Soroka Medical Center ( Site 0548)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Assaf Harofeh MC ( Site 0547)
City
Beer Yaakov-Zerifin
ZIP/Postal Code
7030001
Country
Israel
Facility Name
Rambam Medical Center ( Site 0543)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 0546)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 0544)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 0545)
City
Petach-Tikwa
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 0541)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0542)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 0452)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro ( Site 0458)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
A.O. Universitaria di Modena ( Site 0454)
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Terni ( Site 0456)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Presidio Ospedaliero Santa Chiara ( Site 0451)
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
National Cancer Center Hospital East ( Site 0702)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Toho University Sakura Medical Center ( Site 0703)
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 0716)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0701)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kitasato University Hospital ( Site 0705)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 0706)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 0715)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital ( Site 0714)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 0713)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 0708)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
1932
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center ( Site 0707)
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Hamamatsu University Hospital ( Site 0720)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Yamaguchi University Hospital ( Site 0717)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Chiba Cancer Center ( Site 0704)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0718)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
University of Miyazaki Hospital ( Site 0721)
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Nagasaki University Hospital ( Site 0719)
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Toranomon Hospital ( Site 0711)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 0709)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Keio University Hospital ( Site 0710)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
National Cancer Center ( Site 0174)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0175)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0171)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0176)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0172)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Medisch Centrum Leeuwarden ( Site 0477)
City
Leeuwarden
State/Province
Fryslan
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei ( Site 0485)
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6746 RP
Country
Netherlands
Facility Name
Radboud University Medical Center ( Site 0470)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
VieCuri Medisch Centrum ( Site 0487)
City
Venlo
State/Province
Limburg
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis ( Site 1200)
City
Den Bosch
State/Province
Noord-Brabant
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Catharina Ziekenhuis ( Site 0472)
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Ziekenhuis Hilversum ( Site 0466)
City
Hilversum
State/Province
Noord-Holland
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente ( Site 0469)
City
Hengelo
State/Province
Overijssel
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Reinier de Graaf Groep ( Site 0484)
City
Delft
State/Province
Zuid-Holland
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Hagaziekenhuis ( Site 1201)
City
Den Haag
State/Province
Zuid-Holland
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology ( Site 0559)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117485
Country
Russian Federation
Facility Name
Central Clinical Hospital with Polyclinic ( Site 0562)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
National Medical Research Radiological Center ( Site 0556)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603074
Country
Russian Federation
Facility Name
Omsk Clinical Oncology Dispensary ( Site 0568)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
SPb SBHI City Clinical Oncological Dispensary ( Site 0571)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center ( Site 0588)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia - ICO ( Site 0330)
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Consorci Sanitari Parc Tauli ( Site 0335)
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 0336)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Josep Trueta ( Site 0321)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital del Mar ( Site 0333)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic ( Site 0323)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal ( Site 0328)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 0324)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro ( Site 0322)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 0337)
City
Malaga
ZIP/Postal Code
29016
Country
Spain
Facility Name
Hospital Virgen del Rocio ( Site 0329)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
National Cheng Kung University Hospital ( Site 0134)
City
Tainen
State/Province
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0132)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 0133)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0131)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0135)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
University Hospitals Bristol NHS Foundation Trust ( Site 0530)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Trust ( Site 0540)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Torbay Hospital ( Site 0532)
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Weston Park Hospital ( Site 0539)
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital ( Site 0526)
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 0536)
City
Northwood
State/Province
Hertfordshire
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Barts Cancer Institute ( Site 0483)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
University of North Midlands NHS Foundation Trust ( Site 0527)
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34098744
Citation
Petrylak DP, Ratta R, Gafanov R, Facchini G, Piulats JM, Kramer G, Flaig TW, Chandana SR, Li B, Burgents J, Fizazi K. KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Sep;17(25):3291-3299. doi: 10.2217/fon-2020-1133. Epub 2021 Jun 8.
Results Reference
derived
Links:
URL
http://merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
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)
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