search
Back to results

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Primary Purpose

Metastatic Hormone-Sensitive Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Enzalutamide
Androgen Deprivation Therapy (ADT)
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Hormone-Sensitive Prostate Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1),, Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Has metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)
  • Willing to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization
  • Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
  • Has adequate organ function
  • 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
  • Male participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic
  • Male participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex

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 has current pneumonitis
  • Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Has known or suspected central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of seizure or any condition that may predispose to seizure
  • Has a history of loss of consciousness within 12 months of screening
  • Has had myocardial infarction or uncontrolled angina within 6 months prior to randomization, or has New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure
  • Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
  • Has a history of clinically significant ventricular arrhythmias
  • Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
  • Has received prior ADT as neoadjuvant/adjuvant therapy for non-metastatic prostate cancer for >39 months in duration or within 9 months prior to randomization or with evidence of disease progression while receiving ADT
  • Has had prior treatment with a next generation hormonal agent (eg, abiraterone, enzalutamide, apalutamide, darolutamide)
  • 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 coinhibitory T-cell receptor
  • Has received a live vaccine within 30 days prior to randomization
  • Has a "superscan" bone scan
  • Has had an allogenic tissue/solid organ transplant
  • 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 received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer with the following exceptions:

    1. Up to 3 months of ADT or orchiectomy with or without concurrent first-generation antiandrogens, if patient was not treated with docetaxel
    2. May have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to randomization
    3. For participants with low volume metastatic disease, may have 1 course of definitive radiotherapy if it was administered at least 4 weeks prior to randomization
    4. Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of randomization and no evidence of disease progression. In these participants up to 6 months of ADT permitted

Sites / Locations

  • Alaska Clinical Research Center ( Site 0274)
  • Providence Alaska Medical Center ( Site 0276)
  • City of Hope Medical Center ( Site 0217)
  • UCLA Hematology/Oncology - Santa Monica ( Site 0241)
  • University of Colorado, Anschutz Cancer Pavilion ( Site 0236)
  • Hartford HealthCare Medical Group ( Site 0212)
  • Smilow Cancer Center at Yale-New Haven ( Site 0250)
  • Sibley Memorial Hospital ( Site 0275)
  • Winship Cancer Institute of Emory University ( Site 0209)
  • The University of Chicago ( Site 0264)
  • Springfield Clinic [Springfield, IL] ( Site 0240)
  • Cotton-O'Neil Cancer Center ( Site 0228)
  • The Sidney Kimmel Comprehensive Cancer Center ( Site 0204)
  • St. Vincent Frontier Cancer Center-Research ( Site 0213)
  • Comprehensive Cancer Centers of Nevada ( Site 0269)
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270)
  • Weill Cornell Medical College ( Site 0263)
  • Associated Medical Professionals of NY ( Site 0251)
  • Duke University ( Site 0206)
  • Tri-State Urologic Services PSC, Inc. ( Site 0253)
  • MidLantic Urology ( Site 0273)
  • Ralph H. Johnson VA Center ( Site 0256)
  • Carolina Urologic Research Center ( Site 0259)
  • Urology Associates [Nashville, TN] ( Site 0233)
  • Inova Health System ( Site 0205)
  • Urology of Virginia ( Site 0224)
  • Seattle Cancer Care Alliance ( Site 0258)
  • Chris OBrien Lifehouse ( Site 0300)
  • Port Macquarie Base Hospital ( Site 0301)
  • Riverina Cancer Care Center ( Site 0302)
  • Gallipoli Medical Research Foundation ( Site 0309)
  • John Flynn Hospital & Medical Centre ( Site 0308)
  • Box Hill Hospital ( Site 0304)
  • Monash Health ( Site 0305)
  • Peter MacCallum Cancer Centre ( Site 0306)
  • Fiona Stanley Hospital ( Site 0311)
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0901)
  • Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900)
  • Krankenhaus der Barmherzigen Brüder Wien ( Site 0904)
  • Medizinische Universitaet Wien ( Site 0903)
  • Oncocentro Ceara ( Site 2309)
  • Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306)
  • Hospital Sao Vicente de Paulo ( Site 2303)
  • Hospital de Clinicas de Porto Alegre ( Site 2304)
  • Clinica de Oncologia Reichow ( Site 2308)
  • Fundacao Dr Amaral Carvalho ( Site 2302)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305)
  • The Ottawa Hospital ( Site 0100)
  • Niagara Health System - St. Catharines ( Site 0107)
  • CISSS de la Monteregie-Centre ( Site 0105)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109)
  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106)
  • CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0101)
  • Centro Investigación del Cáncer James Lind ( Site 2401)
  • IC La Serena Research ( Site 2406)
  • Clinica Universidad Catolica del Maule ( Site 2407)
  • Clinica Alemana ( Site 2408)
  • Pontificia Universidad Catolica de Chile ( Site 2402)
  • Sociedad Medica Aren y Bachero Limitada ( Site 2403)
  • Oncocentro ( Site 2400)
  • Peking University First Hospital ( Site 0800)
  • Zhejiang Provincial People's Hospital ( Site 0809)
  • The First Affiliated Hospital of Wenzhou Medical University ( Site 0834)
  • Institucion Prestadora de Servicios de Salud Clinica de la Costa LTDA ( Site 2504)
  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509)
  • Administradora Country SA - Clinica del Country ( Site 2507)
  • Instituto Nacional de Cancerologia E.S.E ( Site 2506)
  • Hemato Oncologos ( Site 2503)
  • Rigshospitalet ( Site 1005)
  • Herlev og Gentofte Hospital. ( Site 1004)
  • Aalborg Universitetshospital ( Site 1000)
  • Odense Universitetshospital ( Site 1003)
  • Vejle Sygehus ( Site 1002)
  • Keski-Suomen keskussairaala ( Site 1017)
  • Tampereen yliopistollinen sairaala ( Site 1022)
  • HYKS ( Site 1020)
  • TYKS T-sairaala Syopatautien pkl ( Site 1019)
  • Centre Leon-Berard ( Site 1110)
  • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114)
  • CHU de Brest -Site Hopital Morvan ( Site 1103)
  • Centre Georges Francois Leclerc ( Site 1112)
  • CHU-Jean Minjoz ( Site 1101)
  • Institut Bergonie ( Site 1104)
  • Hopital Foch ( Site 1105)
  • C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117)
  • Institut Jean Godinot-Clinical Research Unit ( Site 1118)
  • Centre D Oncologie de Gentilly ( Site 1107)
  • Centre Bourgogne ( Site 1119)
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102)
  • Hopital Henri Mondor ( Site 1116)
  • Universitaetsklinikum Freiburg ( Site 1200)
  • Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210)
  • Klinikum Rechts der Isar ( Site 1206)
  • Klinikum Nuernberg Nord ( Site 1213)
  • Staedtisches Klinikum Braunschweig gGmbH ( Site 1217)
  • Universitaetsklinikum Magdeburg A.o.R. ( Site 1211)
  • Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204)
  • Charite Universitaetsmedizin Berlin ( Site 1201)
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 1212)
  • Cork University Hospital ( Site 1304)
  • Beaumont Hospital ( Site 1302)
  • Tallaght University Hospital ( Site 1301)
  • St Vincents University Hospital ( Site 1300)
  • University Hospital Limerick ( Site 1305)
  • University Hospital Waterford ( Site 1303)
  • Rambam Medical Center ( Site 1400)
  • Hadassah Ein Kerem Medical Center ( Site 1404)
  • Meir Medical Center ( Site 1401)
  • Rabin Medical Center ( Site 1402)
  • Sourasky Medical Center ( Site 1403)
  • Assaf Harofeh Medical Center ( Site 1405)
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503)
  • Istituto Clinico Humanitas Research Hospital ( Site 1500)
  • Centro Di Riferimento Oncologico ( Site 1511)
  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509)
  • Azienda Ospedaliera Cannizzaro ( Site 1501)
  • Istituto Nazionale dei Tumori ( Site 1510)
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508)
  • Fondazione Policlinico Universitario A. Gemelli ( Site 1512)
  • Azienda Ospedaliera Santa Maria ( Site 1502)
  • A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504)
  • Toho University Sakura Medical Center ( Site 0732)
  • Ehime University Hospital ( Site 0745)
  • Sapporo Medical University Hospital ( Site 0730)
  • Kitasato University Hospital ( Site 0734)
  • Yokohama City University Medical Center ( Site 0735)
  • Nara Medical University Hospital ( Site 0744)
  • Kindai University Hospital ( Site 0743)
  • Osaka University Hospital ( Site 0742)
  • Saitama Medical University International Medical Center ( Site 0737)
  • Dokkyo Medical University Saitama Medical Center ( Site 0736)
  • Hamamatsu University Hospital ( Site 0748)
  • Yamaguchi University Hospital ( Site 0746)
  • Chiba Cancer Center ( Site 0733)
  • Harasanshin Hospital ( Site 0747)
  • Nagano Municipal Hospital ( Site 0731)
  • Osaka City University Hospital ( Site 0741)
  • Toranomon Hospital ( Site 0740)
  • Nippon Medical School Hospital ( Site 0738)
  • Tokyo Women's Medical University Hospital ( Site 0739)
  • Chonnam National University Hwasun Hospital ( Site 0406)
  • National Cancer Center ( Site 0400)
  • Seoul National University Bundang Hospital ( Site 0401)
  • Kyungpook National University Chilgok Hospital ( Site 0404)
  • Seoul National University Hospital ( Site 0405)
  • Severance Hospital Yonsei University Health System ( Site 0402)
  • Asan Medical Center ( Site 0403)
  • Hospital San Lucas Cardiologica del Sureste ( Site 2606)
  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607)
  • Centro Estatal de Cancerologia de Chihuahua ( Site 2608)
  • Grupo Medico Camino SC ( Site 2613)
  • Centro Oncologico Internacional. SEDNA ( Site 2609)
  • Boca Raton Clinical Research QTO ( Site 2611)
  • Radboud University Medical Center ( Site 1606)
  • Antoni van Leeuwenhoek Ziekenhuis ( Site 1603)
  • Vrije Universiteit Medisch Centrum ( Site 1601)
  • Isala Klinieken, Locatie Sophia ( Site 1604)
  • Meander Medisch Centrum ( Site 1602)
  • Franciscus Gasthuis en Vlietland ( Site 1605)
  • St. Antonius Ziekenhuis ( Site 1600)
  • Auckland City Hospital ( Site 0321)
  • Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700)
  • Clinica Peruano Americana S.A. ( Site 2702)
  • Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708)
  • Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 2706)
  • Hospital Militar Central [Lima, Peru] ( Site 2704)
  • Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716)
  • Nasz Lekarz Przychodnie Medyczne ( Site 1718)
  • Szpital Uniwersytecki w Krakowie ( Site 1707)
  • Radomskie Centrum Onkologii ( Site 1701)
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700)
  • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717)
  • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
  • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709)
  • Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721)
  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810)
  • SBIH City clinical hospital named after D.D. Pletniov ( Site 1813)
  • Russian Scientific Center of Roentgenoradiology ( Site 1800)
  • Volga District Medical Center Federal Medical and Biological Agency ( Site 1805)
  • Omsk Clinical Oncology Dispensary ( Site 1809)
  • Instituto Catalan de Oncologia - ICO ( Site 1901)
  • Hospital Josep Trueta ( Site 1900)
  • Hospital Universitario Lucus Augusti ( Site 1905)
  • Hospital Universitario Ramon y Cajal ( Site 1902)
  • Hospital Clinico San Carlos ( Site 1906)
  • Hospital 12 de Octubre de Madrid ( Site 1903)
  • Hospital Virgen de la Macarena ( Site 1904)
  • Kantonsspital Graubuenden ( Site 2003)
  • Kantonsspital St. Gallen ( Site 2000)
  • CHUV (centre hospitalier universitaire vaudois) ( Site 2002)
  • Universitaetsspital Zuerich ( Site 2001)
  • Kaohsiung Chang Gung Memorial Hospital ( Site 0504)
  • National Cheng Kung University Hospital ( Site 0503)
  • National Taiwan University Hospital ( Site 0500)
  • Taipei Veterans General Hospital ( Site 0501)
  • Chang Gung Medical Foundation. Linkou ( Site 0502)
  • Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600)
  • Ramathibodi Hospital. ( Site 0601)
  • Faculty of Medicine Siriraj Hospital ( Site 0602)
  • Srinagarind Hospital ( Site 0604)
  • Acibadem Adana Hastanesi ( Site 2106)
  • Ankara Universitesi Tip Fakultesi. ( Site 2101)
  • Hacettepe Universitesi Tıp Fakultesi ( Site 2105)
  • Ankara Sehir Hastanesi ( Site 2103)
  • Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100)
  • Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102)
  • Konya Necmettin Erbakan University Medical Faculty ( Site 2104)
  • Aberdeen Royal Infirmary ( Site 1315)
  • Royal Cornwall Hospitals NHS Trust ( Site 1317)
  • University College London Hospitals NHS Foundation Trust ( Site 1320)
  • Royal Marsden NHS Foundation Trust ( Site 1318)
  • Velindre Cancer Centre Hospital ( Site 1322)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab + Enzalutamide + ADT

Placebo + Enzalutamide + ADT

Arm Description

Starting on Day 1 of each 21-day cycle, participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.

Starting on Day 1 of each 21-day cycle, participants receive placebo IV Q3W for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.

Outcomes

Primary Outcome Measures

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
rPFS is defined as the time from randomization to radiographic progression, or death due to any cause, whichever occurs first. rPFS according to PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review will be reported for each study arm.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. OS will be reported for each study arm.

Secondary Outcome Measures

Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever comes first. TFST will be reported for each study arm.
Time to Symptomatic Skeletal-Related Event (TTSSRE)
TTSSRE is defined as the time from randomization to the first Symptomatic Skeletal-Related Event (SSRE), defined as use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral), occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention, whichever occurs first. TTSSRE will be reported for each study arm.
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is 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 is PSA decline from baseline, or 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. Time to PSA progression will be reported for each study arm.
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
Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression, and will be reported for each study arm.
Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Use
TTPP is defined as the time from randomization to pain progression. In this study, pain progression will be assessed by participant responses to Item 3 of the BPI-SF ("worst pain in 24 hours") and by participant opiate use, and will be reported for each study arm.
Time from Randomization to Disease Progression as Determined by Investigator Assessment after Next-line of Therapy or Death from Any Cause, Whichever Occurs First (PFS2)
PFS2 is defined as the time from randomization to disease progression as determined by investigator assessment of radiological or clinical progression after next-line of therapy or death from any cause, whichever occurs first. PFS2 will be reported for each study arm.
Prostate-specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants in the analysis population with PSA decline of ≥50% from baseline measured twice at least 3 weeks apart, and will be reported for each study arm.
Prostate-specific antigen (PSA) Undetectable Rate
PSA undetectable rate is defined as the percentage of participants in the analysis population with PSA < 0.2 ng/mL during study intervention, and will be reported for each study arm.
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 is defined as the percentage of participants in the analysis population who have a best overall response of either confirmed CR or PR. ORR per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review will be reported for each study arm.
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 is defined as the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever occurs first. DOR per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review will be reported for each study arm.
Number of Participants Who Experience an Adverse Event (AE)
An AE is 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 can therefore be 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 experience an AE will be reported for each arm.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is 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 can therefore be 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 discontinue study treatment due to an AE will be reported for each arm.

Full Information

First Posted
December 5, 2019
Last Updated
June 2, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04191096
Brief Title
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
Official Title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
February 2, 2026 (Anticipated)

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
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Hormone-Sensitive Prostate Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1),, Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Enzalutamide + ADT
Arm Type
Experimental
Arm Description
Starting on Day 1 of each 21-day cycle, participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.
Arm Title
Placebo + Enzalutamide + ADT
Arm Type
Placebo Comparator
Arm Description
Starting on Day 1 of each 21-day cycle, participants receive placebo IV Q3W for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Pembrolizumab is administered as an IV infusion at 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
XTANDI®
Intervention Description
Enzalutamide is administered orally as capsules/tablets at a dosage of 160 mg daily. Enzalutamide is administered continuously until criteria for discontinuation are met.
Intervention Type
Procedure
Intervention Name(s)
Androgen Deprivation Therapy (ADT)
Intervention Description
Stable regimen of ADT (LHRH agonist or antagonist) at a dose and frequency of administration that is consistent with the local product label.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo infusion solution is administered as an IV infusion on Day 1 of each 21-day cycle for up to 35 cycles.
Primary Outcome Measure Information:
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
Description
rPFS is defined as the time from randomization to radiographic progression, or death due to any cause, whichever occurs first. rPFS according to PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause. OS will be reported for each study arm.
Time Frame
Up to approximately 32 months
Secondary Outcome Measure Information:
Title
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
Description
TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever comes first. TFST will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Time to Symptomatic Skeletal-Related Event (TTSSRE)
Description
TTSSRE is defined as the time from randomization to the first Symptomatic Skeletal-Related Event (SSRE), defined as use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral), occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention, whichever occurs first. TTSSRE will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is 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 is PSA decline from baseline, or 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. Time to PSA progression will be reported for each study arm.
Time Frame
Up to approximately 32 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
Description
Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression, and will be reported for each study arm.
Time Frame
Up to approximately 32 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 Use
Description
TTPP is defined as the time from randomization to pain progression. In this study, pain progression will be assessed by participant responses to Item 3 of the BPI-SF ("worst pain in 24 hours") and by participant opiate use, and will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Time from Randomization to Disease Progression as Determined by Investigator Assessment after Next-line of Therapy or Death from Any Cause, Whichever Occurs First (PFS2)
Description
PFS2 is defined as the time from randomization to disease progression as determined by investigator assessment of radiological or clinical progression after next-line of therapy or death from any cause, whichever occurs first. PFS2 will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Prostate-specific Antigen (PSA) Response Rate
Description
PSA response rate is defined as the percentage of participants in the analysis population with PSA decline of ≥50% from baseline measured twice at least 3 weeks apart, and will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Prostate-specific antigen (PSA) Undetectable Rate
Description
PSA undetectable rate is defined as the percentage of participants in the analysis population with PSA < 0.2 ng/mL during study intervention, and will be reported for each study arm.
Time Frame
Up to approximately 32 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 is defined as the percentage of participants in the analysis population who have a best overall response of either confirmed CR or PR. ORR per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review will be reported for each study arm.
Time Frame
Up to approximately 32 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 is defined as the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever occurs first. DOR per PCWG-modified RECIST 1.1 as assessed by Blinded Independent Central Review will be reported for each study arm.
Time Frame
Up to approximately 32 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
An AE is 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 can therefore be 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 experience an AE will be reported for each arm.
Time Frame
Up to approximately 41 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
An AE is 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 can therefore be 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 discontinue study treatment due to an AE will be reported for each arm.
Time Frame
Up to approximately 38 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology Has metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI) Willing to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization Has adequate organ function 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 Male participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic Male participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex 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 has current pneumonitis Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Has known or suspected central nervous system (CNS) metastases and/or carcinomatous meningitis Has a history of seizure or any condition that may predispose to seizure Has a history of loss of consciousness within 12 months of screening Has had myocardial infarction or uncontrolled angina within 6 months prior to randomization, or has New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit Has a history of clinically significant ventricular arrhythmias Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients Has received prior ADT as neoadjuvant/adjuvant therapy for non-metastatic prostate cancer for >39 months in duration or within 9 months prior to randomization or with evidence of disease progression while receiving ADT Has had prior treatment with a next generation hormonal agent (eg, abiraterone, enzalutamide, apalutamide, darolutamide) 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 coinhibitory T-cell receptor Has received a live vaccine within 30 days prior to randomization Has a "superscan" bone scan Has had an allogenic tissue/solid organ transplant 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 received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer with the following exceptions: Up to 3 months of ADT or orchiectomy with or without concurrent first-generation antiandrogens, if patient was not treated with docetaxel May have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to randomization For participants with low volume metastatic disease, may have 1 course of definitive radiotherapy if it was administered at least 4 weeks prior to randomization Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of randomization and no evidence of disease progression. In these participants up to 6 months of ADT permitted
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
Alaska Clinical Research Center ( Site 0274)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Providence Alaska Medical Center ( Site 0276)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
City of Hope Medical Center ( Site 0217)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0241)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado, Anschutz Cancer Pavilion ( Site 0236)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford HealthCare Medical Group ( Site 0212)
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06042
Country
United States
Facility Name
Smilow Cancer Center at Yale-New Haven ( Site 0250)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Sibley Memorial Hospital ( Site 0275)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Winship Cancer Institute of Emory University ( Site 0209)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
The University of Chicago ( Site 0264)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Springfield Clinic [Springfield, IL] ( Site 0240)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Cotton-O'Neil Cancer Center ( Site 0228)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center ( Site 0204)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
St. Vincent Frontier Cancer Center-Research ( Site 0213)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada ( Site 0269)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College ( Site 0263)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Associated Medical Professionals of NY ( Site 0251)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University ( Site 0206)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Tri-State Urologic Services PSC, Inc. ( Site 0253)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
MidLantic Urology ( Site 0273)
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Ralph H. Johnson VA Center ( Site 0256)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Carolina Urologic Research Center ( Site 0259)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Associates [Nashville, TN] ( Site 0233)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Inova Health System ( Site 0205)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Urology of Virginia ( Site 0224)
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Seattle Cancer Care Alliance ( Site 0258)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Chris OBrien Lifehouse ( Site 0300)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Port Macquarie Base Hospital ( Site 0301)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Riverina Cancer Care Center ( Site 0302)
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Facility Name
Gallipoli Medical Research Foundation ( Site 0309)
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
John Flynn Hospital & Medical Centre ( Site 0308)
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Box Hill Hospital ( Site 0304)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Health ( Site 0305)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre ( Site 0306)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital ( Site 0311)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 0901)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brüder Wien ( Site 0904)
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Medizinische Universitaet Wien ( Site 0903)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Oncocentro Ceara ( Site 2309)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Facility Name
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80510-130
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo ( Site 2303)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre ( Site 2304)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Clinica de Oncologia Reichow ( Site 2308)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Facility Name
Fundacao Dr Amaral Carvalho ( Site 2302)
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
The Ottawa Hospital ( Site 0100)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Niagara Health System - St. Catharines ( Site 0107)
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0105)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0101)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 2401)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
IC La Serena Research ( Site 2406)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Clinica Universidad Catolica del Maule ( Site 2407)
City
Talca
State/Province
Maule
ZIP/Postal Code
3465584
Country
Chile
Facility Name
Clinica Alemana ( Site 2408)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7650568
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 2402)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Sociedad Medica Aren y Bachero Limitada ( Site 2403)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Oncocentro ( Site 2400)
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Peking University First Hospital ( Site 0800)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Zhejiang Provincial People's Hospital ( Site 0809)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University ( Site 0834)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Institucion Prestadora de Servicios de Salud Clinica de la Costa LTDA ( Site 2504)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Administradora Country SA - Clinica del Country ( Site 2507)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 2506)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110321
Country
Colombia
Facility Name
Hemato Oncologos ( Site 2503)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Rigshospitalet ( Site 1005)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev og Gentofte Hospital. ( Site 1004)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aalborg Universitetshospital ( Site 1000)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Odense Universitetshospital ( Site 1003)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vejle Sygehus ( Site 1002)
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Keski-Suomen keskussairaala ( Site 1017)
City
Jyvaskyla
State/Province
Mellersta Finland
ZIP/Postal Code
40620
Country
Finland
Facility Name
Tampereen yliopistollinen sairaala ( Site 1022)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Facility Name
HYKS ( Site 1020)
City
Helsinki
State/Province
Varsinais-Suomi
ZIP/Postal Code
00290
Country
Finland
Facility Name
TYKS T-sairaala Syopatautien pkl ( Site 1019)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Leon-Berard ( Site 1110)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69373
Country
France
Facility Name
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114)
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67200
Country
France
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 1103)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Georges Francois Leclerc ( Site 1112)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Facility Name
CHU-Jean Minjoz ( Site 1101)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Bergonie ( Site 1104)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Foch ( Site 1105)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92151
Country
France
Facility Name
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
Institut Jean Godinot-Clinical Research Unit ( Site 1118)
City
Reims
State/Province
Marne
ZIP/Postal Code
51726
Country
France
Facility Name
Centre D Oncologie de Gentilly ( Site 1107)
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Bourgogne ( Site 1119)
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59000
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
Hopital Henri Mondor ( Site 1116)
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94010
Country
France
Facility Name
Universitaetsklinikum Freiburg ( Site 1200)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Rechts der Isar ( Site 1206)
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Nuernberg Nord ( Site 1213)
City
Nurnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Staedtisches Klinikum Braunschweig gGmbH ( Site 1217)
City
Braunschweig
State/Province
Niedersachsen
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg A.o.R. ( Site 1211)
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin ( Site 1201)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 1212)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Cork University Hospital ( Site 1304)
City
Cork
ZIP/Postal Code
T12 DC4A
Country
Ireland
Facility Name
Beaumont Hospital ( Site 1302)
City
Dublin
ZIP/Postal Code
00009
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 1301)
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Facility Name
St Vincents University Hospital ( Site 1300)
City
Dublin
ZIP/Postal Code
DO4 YN63
Country
Ireland
Facility Name
University Hospital Limerick ( Site 1305)
City
Limerick
ZIP/Postal Code
V94 F858
Country
Ireland
Facility Name
University Hospital Waterford ( Site 1303)
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Rambam Medical Center ( Site 1400)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 1404)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 1401)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 1402)
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1403)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center ( Site 1405)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503)
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 1500)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Centro Di Riferimento Oncologico ( Site 1511)
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro ( Site 1501)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Istituto Nazionale dei Tumori ( Site 1510)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli ( Site 1512)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria ( Site 1502)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504)
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Toho University Sakura Medical Center ( Site 0732)
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Ehime University Hospital ( Site 0745)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Sapporo Medical University Hospital ( Site 0730)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kitasato University Hospital ( Site 0734)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 0735)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 0744)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital ( Site 0743)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 0742)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 0737)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center ( Site 0736)
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Hamamatsu University Hospital ( Site 0748)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Yamaguchi University Hospital ( Site 0746)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Chiba Cancer Center ( Site 0733)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Harasanshin Hospital ( Site 0747)
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Facility Name
Nagano Municipal Hospital ( Site 0731)
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Osaka City University Hospital ( Site 0741)
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Toranomon Hospital ( Site 0740)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 0738)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital ( Site 0739)
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 0406)
City
Jeollanam-do
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 0400)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0401)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital ( Site 0404)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0405)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0402)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0403)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital San Lucas Cardiologica del Sureste ( Site 2606)
City
Tuxtla Gutierrez
State/Province
Chiapas
ZIP/Postal Code
29090
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Centro Estatal de Cancerologia de Chihuahua ( Site 2608)
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Grupo Medico Camino SC ( Site 2613)
City
Mexico City
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Centro Oncologico Internacional. SEDNA ( Site 2609)
City
Mexico City
ZIP/Postal Code
04700
Country
Mexico
Facility Name
Boca Raton Clinical Research QTO ( Site 2611)
City
Queretaro
ZIP/Postal Code
76070
Country
Mexico
Facility Name
Radboud University Medical Center ( Site 1606)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Antoni van Leeuwenhoek Ziekenhuis ( Site 1603)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum ( Site 1601)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Isala Klinieken, Locatie Sophia ( Site 1604)
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Meander Medisch Centrum ( Site 1602)
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Franciscus Gasthuis en Vlietland ( Site 1605)
City
Schiedam
State/Province
Zuid-Holland
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis ( Site 1600)
City
Utrecht
ZIP/Postal Code
3543 AZ
Country
Netherlands
Facility Name
Auckland City Hospital ( Site 0321)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700)
City
Arequipa
State/Province
Ariqipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Clinica Peruano Americana S.A. ( Site 2702)
City
Trujillo
State/Province
La Libertad
ZIP/Postal Code
13011
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708)
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 2706)
City
Lima
ZIP/Postal Code
15036
Country
Peru
Facility Name
Hospital Militar Central [Lima, Peru] ( Site 2704)
City
Lima
ZIP/Postal Code
15076
Country
Peru
Facility Name
Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Nasz Lekarz Przychodnie Medyczne ( Site 1718)
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie ( Site 1707)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Radomskie Centrum Onkologii ( Site 1701)
City
Radom
State/Province
Mazowieckie
ZIP/Postal Code
26-600
Country
Poland
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717)
City
Bytom
State/Province
Slaskie
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721)
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810)
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 1813)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology ( Site 1800)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Volga District Medical Center Federal Medical and Biological Agency ( Site 1805)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603074
Country
Russian Federation
Facility Name
Omsk Clinical Oncology Dispensary ( Site 1809)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia - ICO ( Site 1901)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Josep Trueta ( Site 1900)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti ( Site 1905)
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal ( Site 1902)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 1906)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre de Madrid ( Site 1903)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Virgen de la Macarena ( Site 1904)
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Kantonsspital Graubuenden ( Site 2003)
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen ( Site 2000)
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
CHUV (centre hospitalier universitaire vaudois) ( Site 2002)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitaetsspital Zuerich ( Site 2001)
City
Zuerich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kaohsiung Chang Gung Memorial Hospital ( Site 0504)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0503)
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0500)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0501)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0502)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital. ( Site 0601)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 0602)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Srinagarind Hospital ( Site 0604)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Acibadem Adana Hastanesi ( Site 2106)
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi. ( Site 2101)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Universitesi Tıp Fakultesi ( Site 2105)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara Sehir Hastanesi ( Site 2103)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102)
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Konya Necmettin Erbakan University Medical Faculty ( Site 2104)
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Aberdeen Royal Infirmary ( Site 1315)
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals NHS Trust ( Site 1317)
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust ( Site 1320)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 1318)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Velindre Cancer Centre Hospital ( Site 1322)
City
Cardiff
ZIP/Postal Code
CF14 2TL
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
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trial Information

Learn more about this trial

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

We'll reach out to this number within 24 hrs