Back to resultsPerioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15)
Primary Purpose
Muscle Invasive Bladder Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Enfortumab vedotin (EV)
RC + PLND
Gemcitabine
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Invasive Bladder Cancer focused on measuring Programmed cell death 1 (PD-1), Programmed Death-Ligand 1 (PD-L1), Programmed Death-Ligand 2 (PD-L2), Pelvic Lymph Node Dissection (PLND), Radical Cystectomy (RC)
Eligibility Criteria
Inclusion Criteria:
- Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology
- Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate organ function
Exclusion Criteria:
- Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
- Has ≥N2 disease or metastatic disease (M1) as identified by imaging
- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
- Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
- Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
- Has a known psychiatric or substance abuse disorder
- Has had an allogenic tissue/solid organ transplant
- Has ongoing sensory or motor neuropathy Grade 2 or higher
- Has active keratitis (superficial punctate keratitis) or corneal ulcerations
- Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms
Sites / Locations
- Mayo Clinic in Arizona - Phoenix ( Site 0043)Recruiting
- St Joseph Heritage Healthcare-Oncology ( Site 0035)
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of UroRecruiting
- University of California San Francisco ( Site 0010)Recruiting
- Stanford University ( Site 0023)Recruiting
- University of Colorado, Anschutz Cancer Pavilion ( Site 0009)Recruiting
- UF Health ( Site 0031)Recruiting
- Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)Recruiting
- University of Iowa Hospital and Clinics ( Site 0029)Recruiting
- University of Louisville, James Graham Brown Cancer Center ( Site 0022)Recruiting
- Icahn School of Medicine at Mount Sinai ( Site 0011)Recruiting
- White Plains Hospital ( Site 0039)Recruiting
- Duke University Medical Center ( Site 0017)Recruiting
- Wake Forest Baptist Health ( Site 0014)Recruiting
- Oregon Health and Science University ( Site 0028)Recruiting
- MidLantic Urology ( Site 0002)Recruiting
- Saint Francis Cancer Center ( Site 0008)Recruiting
- The University of Tennessee Medical Center ( Site 0034)
- UT Southwestern Medical Center ( Site 0003)Recruiting
- Houston Methodist Urology Associates ( Site 0033)Recruiting
- Urology of San Antonio ( Site 0020)Recruiting
- University of Wisconsin Hospital and Clinics ( Site 0037)Recruiting
- Hospital Británico de Buenos Aires-Oncology ( Site 1551)Recruiting
- Hospital Italiano de Buenos Aires ( Site 1554)Recruiting
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)Recruiting
- Fundacion Estudios Clinicos-Oncology ( Site 1557)Recruiting
- Centro de Urología (CDU) ( Site 1552)Recruiting
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)Recruiting
- Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)Recruiting
- Mater Hospital Brisbane ( Site 1257)
- Lyell McEwin Hospital ( Site 1252)Recruiting
- Frankston Hospital-Oncology and Haematology ( Site 1258)Recruiting
- MHAT "Uni Hospital" OOD ( Site 1154)Recruiting
- Complex Oncology Center Plovdiv ( Site 1151)Recruiting
- MHAT Central Onco Hospital OOD ( Site 1158)Recruiting
- MHAT Serdika ( Site 1152)Recruiting
- BC Cancer - Vancouver Center ( Site 0110)Recruiting
- CancerCare Manitoba ( Site 0108)Recruiting
- Moncton Hospital ( Site 0107)Recruiting
- Ottawa Hospital Research Institute ( Site 0109)Recruiting
- Jewish General Hospital ( Site 0106)Recruiting
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)Recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)Recruiting
- Hunan Cancer Hospital ( Site 1403)Recruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( SRecruiting
- Nantong Tumor Hospital-Urology ( Site 1405)
- Fudan University Shanghai Cancer Center-Urology department ( Site 1401)Recruiting
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)Recruiting
- Fundación Colombiana de Cancerología Clínica Vida ( Site 1653)Recruiting
- Oncomédica S.A.S ( Site 1652)Recruiting
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)Recruiting
- Fundación Cardiovascular de Colombia-Santander ( Site 1657)Recruiting
- Fundacion Valle del Lili- CIC ( Site 1656)Recruiting
- Klinički bolnički centar Sestre milosrdnice ( Site 1703)Recruiting
- Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)Recruiting
- Klinički bolnički centar Osijek ( Site 1705)Recruiting
- Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)Recruiting
- Fakultni nemocnice u sv. Anny v Brne ( Site 0253)Recruiting
- Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)Recruiting
- Fakultni Nemocnice Olomouc ( Site 0251)Recruiting
- Fakultni Thomayerova nemocnice ( Site 0252)Recruiting
- CHU La Timone ( Site 0456)Recruiting
- CHU Jean Minjoz ( Site 0453)Recruiting
- CHU de Brest -Site Hopital Morvan ( Site 0461)Recruiting
- Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)Recruiting
- CHU Limoges Hopital Dupuytren ( Site 0459)Recruiting
- Gustave Roussy ( Site 0467)Recruiting
- CHU GRENOBLE ALPES ( Site 0468)Recruiting
- Centre Hospitalier Regional du Orleans ( Site 0463)Recruiting
- Polyclinique du Bois ( Site 0458)Recruiting
- Hopital Diaconesses Croix Saint Simon ( Site 0465)Recruiting
- Universitaetsklinikum Freiburg ( Site 0512)Recruiting
- Universitaetsklinik fuer Urologie ( Site 0501)Recruiting
- Caritas Krankenhaus St. Josef ( Site 0502)Recruiting
- Universitaetsklinikum Wuerzburg ( Site 0520)Recruiting
- Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)Recruiting
- Universitaetsklinikum Muenster ( Site 0516)Recruiting
- Krankenhaus Martha Maria Halle-Doelau ( Site 0507)Recruiting
- Universitaetsklinikum Carl Gustav Carus ( Site 0509)Recruiting
- Vivantes Klinikum Am Urban ( Site 0519)Recruiting
- UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)Recruiting
- General Hospital of Athens "Alexandra" ( Site 0303)Recruiting
- Athens Medical Center ( Site 0304)Recruiting
- ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)Recruiting
- University General Hospital of Larissa ( Site 0302)Recruiting
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)Recruiting
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 1006)Recruiting
- Rambam Health Care Campus-Oncology ( Site 0751)Recruiting
- Hadassah Medical Center-Oncology ( Site 0757)Recruiting
- Meir Medical Center-oncology ( Site 0754)Recruiting
- Rabin Medical Center-Oncology ( Site 0752)Recruiting
- Sheba Medical Center-ONCOLOGY ( Site 0753)Recruiting
- Sourasky Medical Center-Oncology ( Site 0755)Recruiting
- Yitzhak Shamir Medical Center-Oncology ( Site 0756)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)Recruiting
- Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)Recruiting
- AOU San Luigi Gonzaga di Orbassano ( Site 0595)Recruiting
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)Recruiting
- Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)Recruiting
- Ospedale Cannizzaro ( Site 0590)Recruiting
- IRCCS Ospedale San Raffaele ( Site 0596)Recruiting
- Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)Recruiting
- Nagoya University Hospital ( Site 1512)Recruiting
- Hirosaki University Hospital ( Site 1501)Recruiting
- University of Tsukuba Hospital ( Site 1502)Recruiting
- Kanazawa University Hospital ( Site 1509)Recruiting
- Kitasato University Hospital ( Site 1506)Recruiting
- Yokohama City University Medical Center ( Site 1508)
- Kanagawa Cancer Center ( Site 1507)Recruiting
- Tohoku University Hospital ( Site 1503)Recruiting
- Hamamatsu University Hospital ( Site 1511)Recruiting
- Gifu University Hospital ( Site 1513)Recruiting
- Nagasaki University Hospital ( Site 1517)Recruiting
- Okayama University Hospital ( Site 1516)Recruiting
- Osaka International Cancer Institute ( Site 1514)Recruiting
- Osaka Metropolitan University Hospital ( Site 1515)Recruiting
- Tokyo Medical and Dental University Hospital ( Site 1505)Recruiting
- Keio University Hospital ( Site 1504)Recruiting
- Toyama University Hospital ( Site 1510)Recruiting
- Chonnam National University Hwasun Hospital ( Site 1353)Recruiting
- Seoul National University Bundang Hospital ( Site 1355)Recruiting
- Asan Medical Center ( Site 1352)Recruiting
- Kyungpook National University Chilgok Hospital ( Site 1354)Recruiting
- Gachon University Gil Medical Center ( Site 1356)Recruiting
- Korea University Anam Hospital ( Site 1357)Recruiting
- Seoul National University Hospital ( Site 1351)Recruiting
- University Malaya Medical Centre ( Site 0352)Recruiting
- Hospital Pulau Pinang ( Site 0355)Recruiting
- Sarawak General Hospital ( Site 0351)Recruiting
- Sunway Medical Centre ( Site 0353)Recruiting
- THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-IloRecruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)Recruiting
- Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)Recruiting
- Narodowy Instytut Onkologii ( Site 1051)Recruiting
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)Recruiting
- Clinical Research Center Medic-R ( Site 1061)Recruiting
- Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)Recruiting
- Centro Hospitalar e Universitario de Coimbra ( Site 0406)Recruiting
- Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)Recruiting
- CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)Recruiting
- Hospital Geral de Santo Antonio ( Site 0408)Recruiting
- Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)Recruiting
- Cardiomed SRL Cluj-Napoca ( Site 1101)Recruiting
- Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)Recruiting
- SC Radiotherapy Center Cluj SRL ( Site 1108)Recruiting
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)Recruiting
- Policlinica Oncomed SRL ( Site 1106)Recruiting
- SC Focus Lab Plus SRL ( Site 1104)Recruiting
- Altay Regional Oncology Dispensary ( Site 0851)
- National Medical Research Radiology Centre ( Site 0869)
- National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)
- First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)
- Volga District Medical Center ( Site 0876)
- St.Petersburg Clinical Hospital RAS ( Site 0864)
- St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)
- Sverdlovsk Regional Oncology Hospital ( Site 0867)
- Sverdlovsky Regional Clinical hospital #1 ( Site 0868)
- Volgograd Regional Uronephrological Center ( Site 0870)
- Tan Tock Seng Hospital ( Site 0704)Recruiting
- Wits Clinical Research ( Site 0603)Recruiting
- Steve Biko Academic Hospital ( Site 0601)Recruiting
- Groote Schuur Hospital ( Site 0602)Recruiting
- Hospital Universitario Central de Asturias ( Site 0654)Recruiting
- Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)Recruiting
- Xarxa Assistencial Universitaria Manresa ( Site 0655)Recruiting
- Institut Català d'Oncologia (ICO) - Girona ( Site 0653)Recruiting
- CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)Recruiting
- Hospital Universitario Insular de Gran Canaria ( Site 0657)Recruiting
- Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)Recruiting
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)Recruiting
- Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)Recruiting
- Hospital Virgen del Rocio ( Site 0659)Recruiting
- Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)Recruiting
- China Medical University Hospital ( Site 1202)Recruiting
- Taipei Veterans General Hospital ( Site 1201)Recruiting
- I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)
- MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)
- MNPE Regional Center of Oncology ( Site 0955)Recruiting
- Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)
- Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)
- Zhytomyr Regional Oncology Center ( Site 0961)
- Torbay Hospital ( Site 1804)Recruiting
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)Recruiting
- Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital ( Site 1802)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND
Arm Description
Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Outcomes
Primary Outcome Measures
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the first occurrence of following events: radiographic disease progression precluding RC + PLND, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause.
Secondary Outcome Measures
Pathologic Complete Response (pCR) Rate
pCR rate is defined as defined as the proportion of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from radical cystectomy (RC) + pelvic lymph node dissection (PLND), as assessed by blinded central pathologic review.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Pathologic Downstaging (pDS) Rate
pDS is defined as participants with <pT2 (includes pT0, pTis, pTa, and pT1) and N0 in examined tissue from RC plus PLND, based on central pathologic review.
Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
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. The number of participants who experience an AE will be presented.
Disease Free Survival (DFS)
DFS is defined as the time from postsurgery baseline scan until the first occurrence of either local/distant recurrence as assessed by BICR imaging and/or biopsy or death from any cause.
Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
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. The number of participants who discontinue study treatment due to an AE will be presented.
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.
Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
The BCI is a 36-item validated, condition-specific health questionnaire to assess the quality of life among participants with bladder cancer. The BCI contains 3 domains: urinary (14 items), bowel (10 items), and sexual (12 items) with function (Likert response scale: 0 [Never] - 4 [Always]) and bother (Likert response scale: 0 [No problem] - 4 [Big problem]) subdomains. The domain and subdomain scores are standardized to a 0 to 100 point scale where higher scores correspond better functioning and health-related qualify of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.
Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30)
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. TTD is defined as time from baseline to first onset of EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 & 30) deterioration based on established minimal important differences (MIDs) threshold. Deterioration in the global health status/quality of life of the EORTC QLQ-C30 is defined as a 10 points or greater worsening from baseline, with or without subsequent confirmation, under a right-censoring rule.
TTD in the Physical Functioning Scale per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. The TTD is defined as the time from baseline to first onset of the physical functioning scale per EORTC QLQ-C30 deterioration based on established MIDs threshold. Deterioration is defined as a 10 points or greater worsening from baseline with or without subsequent confirmation, under a right-censoring rule.
TTD in the Urinary, Bowel and Sexual Domains per BCI
The 36-item BCI contains 3 domains: urinary (14 items), bowel (10 items), and sexual (12 items) with function (Likert response scale: 0 [Never] - 4 [Always]) and bother (Likert response scale: 0 [No problem] - 4 [Big problem]) subdomains. The domain and subdomain scores are standardized to a 0 to 100 point scale where higher scores correspond to better functioning and health-related quality of life. TTD is defined as time from baseline to first onset of urinary, bowel and sexual domains per BCI deterioration based on established MIDs threshold. Deterioration is defined based on the published median MIDs as a 6, 7, and 7 points or greater worsening from baseline for urinary, bowel, and sexual domains, respectively, with or without subsequent confirmation, under a right-censoring rule.
TTD in the EQ-5D-5L VAS
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD is defined as the time from baseline to first onset of EQ-5D-5L VAS deterioration based on established MIDs threshold. Deterioration in score is defined in as a 7 points or greater worsening from baseline with or without subsequent confirmation, under a right-censoring rule.
Full Information
NCT ID
NCT04700124
First Posted
January 5, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Seagen Inc., Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT04700124
Brief Title
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Acronym
KEYNOTE-B15
Official Title
A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
December 23, 2026 (Anticipated)
Study Completion Date
December 23, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Seagen Inc., Astellas Pharma Inc
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 antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Invasive Bladder Cancer
Keywords
Programmed cell death 1 (PD-1), Programmed Death-Ligand 1 (PD-L1), Programmed Death-Ligand 2 (PD-L2), Pelvic Lymph Node Dissection (PLND), Radical Cystectomy (RC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
784 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
Arm Type
Experimental
Arm Description
Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Arm Title
Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND
Arm Type
Active Comparator
Arm Description
Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
200 mg of Pembrolizumab IV infusion, on Day 1 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 Q3W for 13 cycles in postoperative phase (up to approximately 9 months). The total duration of treatment is up to approximately 1 year.
Intervention Type
Biological
Intervention Name(s)
Enfortumab vedotin (EV)
Other Intervention Name(s)
Padcev
Intervention Description
1.25 mg/kg of EV IV infusion, on Day 1 and Day 8 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 and Day 8 Q3W for 5 cycles (each cycle length = 21 days) in postoperative phase (up to approximately 4 months). The total duration of treatment is up to approximately 7 months.
Intervention Type
Procedure
Intervention Name(s)
RC + PLND
Other Intervention Name(s)
Surgery
Intervention Description
Curative intent RC + PLND surgery will be administered to all participants randomized to Arm A and B after completion of preoperative systemic treatment (RC + PLND to be done approximately at 15 weeks from randomization).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1000 mg/m^2 of Gemcitabine IV infusion, Day 1 and Day 8 Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol®, Platinol®-AQ
Intervention Description
70 mg/m^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS)
Description
EFS is defined as the time from randomization to the first occurrence of following events: radiographic disease progression precluding RC + PLND, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause.
Time Frame
Up to ~68 months
Secondary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
pCR rate is defined as defined as the proportion of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from radical cystectomy (RC) + pelvic lymph node dissection (PLND), as assessed by blinded central pathologic review.
Time Frame
Up to ~47 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~68 months
Title
Pathologic Downstaging (pDS) Rate
Description
pDS is defined as participants with <pT2 (includes pT0, pTis, pTa, and pT1) and N0 in examined tissue from RC plus PLND, based on central pathologic review.
Time Frame
Up to ~47 months
Title
Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
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. The number of participants who experience an AE will be presented.
Time Frame
Up to ~68 months
Title
Disease Free Survival (DFS)
Description
DFS is defined as the time from postsurgery baseline scan until the first occurrence of either local/distant recurrence as assessed by BICR imaging and/or biopsy or death from any cause.
Time Frame
From ~12 months to up to ~68 months
Title
Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
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. The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to ~68 months
Title
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Description
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
Time Frame
Baseline, Up to ~68 months
Title
Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
Description
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.
Time Frame
Baseline, Up to ~68 months
Title
Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
Description
The BCI is a 36-item validated, condition-specific health questionnaire to assess the quality of life among participants with bladder cancer. The BCI contains 3 domains: urinary (14 items), bowel (10 items), and sexual (12 items) with function (Likert response scale: 0 [Never] - 4 [Always]) and bother (Likert response scale: 0 [No problem] - 4 [Big problem]) subdomains. The domain and subdomain scores are standardized to a 0 to 100 point scale where higher scores correspond better functioning and health-related qualify of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.
Time Frame
Baseline, Up to ~68 months
Title
Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)
Description
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Time Frame
Baseline, Up to ~68 months
Title
Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30)
Description
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. TTD is defined as time from baseline to first onset of EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 & 30) deterioration based on established minimal important differences (MIDs) threshold. Deterioration in the global health status/quality of life of the EORTC QLQ-C30 is defined as a 10 points or greater worsening from baseline, with or without subsequent confirmation, under a right-censoring rule.
Time Frame
Up to ~68 months
Title
TTD in the Physical Functioning Scale per EORTC QLQ-C30
Description
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. The TTD is defined as the time from baseline to first onset of the physical functioning scale per EORTC QLQ-C30 deterioration based on established MIDs threshold. Deterioration is defined as a 10 points or greater worsening from baseline with or without subsequent confirmation, under a right-censoring rule.
Time Frame
Up to ~68 months
Title
TTD in the Urinary, Bowel and Sexual Domains per BCI
Description
The 36-item BCI contains 3 domains: urinary (14 items), bowel (10 items), and sexual (12 items) with function (Likert response scale: 0 [Never] - 4 [Always]) and bother (Likert response scale: 0 [No problem] - 4 [Big problem]) subdomains. The domain and subdomain scores are standardized to a 0 to 100 point scale where higher scores correspond to better functioning and health-related quality of life. TTD is defined as time from baseline to first onset of urinary, bowel and sexual domains per BCI deterioration based on established MIDs threshold. Deterioration is defined based on the published median MIDs as a 6, 7, and 7 points or greater worsening from baseline for urinary, bowel, and sexual domains, respectively, with or without subsequent confirmation, under a right-censoring rule.
Time Frame
Up to ~68 months
Title
TTD in the EQ-5D-5L VAS
Description
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD is defined as the time from baseline to first onset of EQ-5D-5L VAS deterioration based on established MIDs threshold. Deterioration in score is defined in as a 7 points or greater worsening from baseline with or without subsequent confirmation, under a right-censoring rule.
Time Frame
Up to ~68 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate organ function.
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
Has ≥N2 disease or metastatic disease (M1) as identified by imaging
Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
Has a known psychiatric or substance abuse disorder
Has had an allogenic tissue/solid organ transplant
Has ongoing sensory or motor neuropathy Grade 2 or higher
Has active keratitis (superficial punctate keratitis) or corneal ulcerations
Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
Mayo Clinic in Arizona - Phoenix ( Site 0043)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
480-342-2000
Facility Name
St Joseph Heritage Healthcare-Oncology ( Site 0035)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Completed
Facility Name
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-451-8751
Facility Name
University of California San Francisco ( Site 0010)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
773-837-0783
Facility Name
Stanford University ( Site 0023)
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-725-2078
Facility Name
University of Colorado, Anschutz Cancer Pavilion ( Site 0009)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
303-724-0499
Facility Name
UF Health ( Site 0031)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
352-265-0725
Facility Name
Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-944-5349
Facility Name
University of Iowa Hospital and Clinics ( Site 0029)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
319-384-8076
Facility Name
University of Louisville, James Graham Brown Cancer Center ( Site 0022)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-562-3429
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 0011)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-659-5452
Facility Name
White Plains Hospital ( Site 0039)
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
914-849-7630
Facility Name
Duke University Medical Center ( Site 0017)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
919-613-4494
Facility Name
Wake Forest Baptist Health ( Site 0014)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
336-713-5440
Facility Name
Oregon Health and Science University ( Site 0028)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-346-8089
Facility Name
MidLantic Urology ( Site 0002)
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
610-667-0458
Facility Name
Saint Francis Cancer Center ( Site 0008)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
863-603-6300
Facility Name
The University of Tennessee Medical Center ( Site 0034)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Completed
Facility Name
UT Southwestern Medical Center ( Site 0003)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-648-6585
Facility Name
Houston Methodist Urology Associates ( Site 0033)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
346-238-6123
Facility Name
Urology of San Antonio ( Site 0020)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-614-4116
Facility Name
University of Wisconsin Hospital and Clinics ( Site 0037)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-622-8922
Facility Name
Hospital Británico de Buenos Aires-Oncology ( Site 1551)
City
Ciudad autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 11 4309-6400
Facility Name
Hospital Italiano de Buenos Aires ( Site 1554)
City
ABB
State/Province
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541149590200
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541152990100
Facility Name
Fundacion Estudios Clinicos-Oncology ( Site 1557)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5493469699922
Facility Name
Centro de Urología (CDU) ( Site 1552)
City
Buenos Aires
ZIP/Postal Code
1120
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541149642424
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
54 11 4574-4343
Facility Name
Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0402856430
Facility Name
Mater Hospital Brisbane ( Site 1257)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Lyell McEwin Hospital ( Site 1252)
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61882820833
Facility Name
Frankston Hospital-Oncology and Haematology ( Site 1258)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61425733507
Facility Name
MHAT "Uni Hospital" OOD ( Site 1154)
City
Panagyurishte
State/Province
Pazardzhik
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359888938571
Facility Name
Complex Oncology Center Plovdiv ( Site 1151)
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359899822788
Facility Name
MHAT Central Onco Hospital OOD ( Site 1158)
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359888431354
Facility Name
MHAT Serdika ( Site 1152)
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359888223107
Facility Name
BC Cancer - Vancouver Center ( Site 0110)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6048776000
Facility Name
CancerCare Manitoba ( Site 0108)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
204-787-1992
Facility Name
Moncton Hospital ( Site 0107)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
506-857-5669
Facility Name
Ottawa Hospital Research Institute ( Site 0109)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
613-737-7700
Facility Name
Jewish General Hospital ( Site 0106)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-340-8222
Facility Name
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-87343585
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-34071255
Facility Name
Hunan Cancer Hospital ( Site 1403)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86073188651900
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02568182222
Facility Name
Nantong Tumor Hospital-Urology ( Site 1405)
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Individual Site Status
Completed
Facility Name
Fudan University Shanghai Cancer Center-Urology department ( Site 1401)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13701663571
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02158752345
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 1653)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
57 (604) 4480016 Ext.2404
Facility Name
Oncomédica S.A.S ( Site 1652)
City
Montería
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+57 (604) 7862333 Ext: 4007
Facility Name
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573103469453
Facility Name
Fundación Cardiovascular de Colombia-Santander ( Site 1657)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573203400438
Facility Name
Fundacion Valle del Lili- CIC ( Site 1656)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
57233190904022
Facility Name
Klinički bolnički centar Sestre milosrdnice ( Site 1703)
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+385913860091
Facility Name
Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
012388575
Facility Name
Klinički bolnički centar Osijek ( Site 1705)
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
031511490
Facility Name
Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
385915297299
Facility Name
Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
City
Brno
State/Province
Jihomoravsky Kraj
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420543183073
Facility Name
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420495834980
Facility Name
Fakultni Nemocnice Olomouc ( Site 0251)
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420588444288
Facility Name
Fakultni Thomayerova nemocnice ( Site 0252)
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00420261083530
Facility Name
CHU La Timone ( Site 0456)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33491385708
Facility Name
CHU Jean Minjoz ( Site 0453)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33370632403
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 0461)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33298223395
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33531155993
Facility Name
CHU Limoges Hopital Dupuytren ( Site 0459)
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33555056396
Facility Name
Gustave Roussy ( Site 0467)
City
Villejuif
State/Province
Ile-de-France
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33142115348
Facility Name
CHU GRENOBLE ALPES ( Site 0468)
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33476767971
Facility Name
Centre Hospitalier Regional du Orleans ( Site 0463)
City
Orleans
State/Province
Loiret
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33238514444
Facility Name
Polyclinique du Bois ( Site 0458)
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33 320009757
Facility Name
Hopital Diaconesses Croix Saint Simon ( Site 0465)
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33144742839
Facility Name
Universitaetsklinikum Freiburg ( Site 0512)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4976127028930
Facility Name
Universitaetsklinik fuer Urologie ( Site 0501)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4970712985268
Facility Name
Caritas Krankenhaus St. Josef ( Site 0502)
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+499417820
Facility Name
Universitaetsklinikum Wuerzburg ( Site 0520)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
49 931 201 32001
Facility Name
Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4923234991660
Facility Name
Universitaetsklinikum Muenster ( Site 0516)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
492518348001
Facility Name
Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493455591449
Facility Name
Universitaetsklinikum Carl Gustav Carus ( Site 0509)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00493514582157
Facility Name
Vivantes Klinikum Am Urban ( Site 0519)
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004930130226365
Facility Name
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)
City
Patras
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302610999791
Facility Name
General Hospital of Athens "Alexandra" ( Site 0303)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0302132162513
Facility Name
Athens Medical Center ( Site 0304)
City
Athens
State/Province
Attiki
ZIP/Postal Code
151 25
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302106157392
Facility Name
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302105831255
Facility Name
University General Hospital of Larissa ( Site 0302)
City
Larissa
State/Province
Thessalia
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302413502027
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3662545405
Facility Name
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36209323256
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3652255585
Facility Name
Rambam Health Care Campus-Oncology ( Site 0751)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972-4-7776400
Facility Name
Hadassah Medical Center-Oncology ( Site 0757)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972505172315
Facility Name
Meir Medical Center-oncology ( Site 0754)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97297472337
Facility Name
Rabin Medical Center-Oncology ( Site 0752)
City
Petah-Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97239378074
Facility Name
Sheba Medical Center-ONCOLOGY ( Site 0753)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972-3-5302191
Facility Name
Sourasky Medical Center-Oncology ( Site 0755)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97236947616
Facility Name
Yitzhak Shamir Medical Center-Oncology ( Site 0756)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972 8 9779715
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390223904450
Facility Name
Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
City
Pozzuoli
State/Province
Napoli
ZIP/Postal Code
80078
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
08118844048
Facility Name
AOU San Luigi Gonzaga di Orbassano ( Site 0595)
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390119026993
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390458122768
Facility Name
Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390715964169
Facility Name
Ospedale Cannizzaro ( Site 0590)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 3487142015
Facility Name
IRCCS Ospedale San Raffaele ( Site 0596)
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390226435789
Facility Name
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390498215908
Facility Name
Nagoya University Hospital ( Site 1512)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-741-2111
Facility Name
Hirosaki University Hospital ( Site 1501)
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-172-33-5111
Facility Name
University of Tsukuba Hospital ( Site 1502)
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-29-853-3900
Facility Name
Kanazawa University Hospital ( Site 1509)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-76-265-2000
Facility Name
Kitasato University Hospital ( Site 1506)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-42-778-8111
Facility Name
Yokohama City University Medical Center ( Site 1508)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Completed
Facility Name
Kanagawa Cancer Center ( Site 1507)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-45-520-2222
Facility Name
Tohoku University Hospital ( Site 1503)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-717-7000
Facility Name
Hamamatsu University Hospital ( Site 1511)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-53-435-2111
Facility Name
Gifu University Hospital ( Site 1513)
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-58-230-6000
Facility Name
Nagasaki University Hospital ( Site 1517)
City
Nagasaki
ZIP/Postal Code
852-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-95-819-7200
Facility Name
Okayama University Hospital ( Site 1516)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-86-223-7151
Facility Name
Osaka International Cancer Institute ( Site 1514)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6945-1181
Facility Name
Osaka Metropolitan University Hospital ( Site 1515)
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6645-2121
Facility Name
Tokyo Medical and Dental University Hospital ( Site 1505)
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3813-6111
Facility Name
Keio University Hospital ( Site 1504)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3353-1211
Facility Name
Toyama University Hospital ( Site 1510)
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-76-434-2281
Facility Name
Chonnam National University Hwasun Hospital ( Site 1353)
City
Jeollanam-do
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82613797745
Facility Name
Seoul National University Bundang Hospital ( Site 1355)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82317877351
Facility Name
Asan Medical Center ( Site 1352)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82230103980
Facility Name
Kyungpook National University Chilgok Hospital ( Site 1354)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82532002672
Facility Name
Gachon University Gil Medical Center ( Site 1356)
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82324603231
Facility Name
Korea University Anam Hospital ( Site 1357)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8229205530
Facility Name
Seoul National University Hospital ( Site 1351)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220720361
Facility Name
University Malaya Medical Centre ( Site 0352)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60379492120
Facility Name
Hospital Pulau Pinang ( Site 0355)
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+604 222 5711
Facility Name
Sarawak General Hospital ( Site 0351)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6082-276666 ext. 6030
Facility Name
Sunway Medical Centre ( Site 0353)
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47500
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+603 7491 9191
Facility Name
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo
City
Iloilo City
State/Province
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639274761729
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48601143281
Facility Name
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48 25 64 03 485
Facility Name
Narodowy Instytut Onkologii ( Site 1051)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48225462331
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48 16 677 55 11
Facility Name
Clinical Research Center Medic-R ( Site 1061)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48500799053
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48502204953
Facility Name
Centro Hospitalar e Universitario de Coimbra ( Site 0406)
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351239400457
Facility Name
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217229800
Facility Name
CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351210431704
Facility Name
Hospital Geral de Santo Antonio ( Site 0408)
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351222077500
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40745976913
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 1101)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721254415
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4026459831
Facility Name
SC Radiotherapy Center Cluj SRL ( Site 1108)
City
Comuna Floresti
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40742206212
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40727774974
Facility Name
Policlinica Oncomed SRL ( Site 1106)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40256495403
Facility Name
SC Focus Lab Plus SRL ( Site 1104)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721298677
Facility Name
Altay Regional Oncology Dispensary ( Site 0851)
City
Barnaul
State/Province
Altayskiy Kray
ZIP/Postal Code
656040
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
National Medical Research Radiology Centre ( Site 0869)
City
Obninsk
State/Province
Kaluzskaja Oblast
ZIP/Postal Code
249036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115230
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Volga District Medical Center ( Site 0876)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603074
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
St.Petersburg Clinical Hospital RAS ( Site 0864)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194017
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197101
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Sverdlovsk Regional Oncology Hospital ( Site 0867)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Sverdlovsky Regional Clinical hospital #1 ( Site 0868)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Volgograd Regional Uronephrological Center ( Site 0870)
City
Volzhsky
State/Province
Volgogradskaya Oblast
ZIP/Postal Code
404120
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Tan Tock Seng Hospital ( Site 0704)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
308442
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6562566011
Facility Name
Wits Clinical Research ( Site 0603)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27113390600
Facility Name
Steve Biko Academic Hospital ( Site 0601)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27123466701
Facility Name
Groote Schuur Hospital ( Site 0602)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27(0)214044265
Facility Name
Hospital Universitario Central de Asturias ( Site 0654)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34985106121
Facility Name
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934651200
Facility Name
Xarxa Assistencial Universitaria Manresa ( Site 0655)
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34938759300
Facility Name
Institut Català d'Oncologia (ICO) - Girona ( Site 0653)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34972225832
Facility Name
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34981950511
Facility Name
Hospital Universitario Insular de Gran Canaria ( Site 0657)
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34961452191
Facility Name
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34961114229
Facility Name
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934894350
Facility Name
Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913303000 x7554
Facility Name
Hospital Virgen del Rocio ( Site 0659)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955012000
Facility Name
Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88677317123
Facility Name
China Medical University Hospital ( Site 1202)
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
04-22052121 #2955
Facility Name
Taipei Veterans General Hospital ( Site 1201)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-2-28757519 ext. 306
Facility Name
I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61037
Country
Ukraine
Individual Site Status
Suspended
Facility Name
MNPE Regional Center of Oncology ( Site 0955)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+380573151591
Facility Name
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61166
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Zhytomyr Regional Oncology Center ( Site 0961)
City
Zhytomyr
State/Province
Zhytomyrska Oblast
ZIP/Postal Code
10002
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Torbay Hospital ( Site 1804)
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4401803655376
Facility Name
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020 7822 8498
Facility Name
Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital ( Site 1802)
City
London
State/Province
London, City Of
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
442033110277
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
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
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