Bladder Cancer Clinical Trial

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Summary

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior pathologic complete response (pCR) rates (based on central pathologic review) and event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a histologically confirmed diagnosis of urothelial carcinoma/muscle-invasive bladder cancer [MIBC] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).
Clinically nonmetastatic bladder cancer determined by imaging
Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)

Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria OR be eligible for treatment with cisplatin but decline treatment with cisplatin-based chemotherapy:

Impaired renal function with measured or calculated creatinine clearance (CrCl) 30 to 59 mL/min (calculated by Cockcroft-Gault method, Modification of Diet of Renal Disease [MDRD] equations, or measured by 24-hour urine collection)
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss
New York Heart Association (NYHA) Class III heart failure
Transurethral resection (TUR) of a bladder tumor that is submitted for central pathology assessment and adequate to determine urothelial histology and PD-L1 expression assessment
ECOG performance status of 0, 1, or 2
Adequate organ function
A male participant is eligible to participate if he agrees to use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of enfortumab vedotin. If the male participants are receiving pembrolizumab only or undergoing surgery only, there are no contraception requirements
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well
A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Exclusion Criteria:

Known additional nonurothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions
Has ≥ N2 or metastatic disease (M1) as identified by imaging
Received any prior systemic treatment, chemoradiation, and/or radiation therapy for for muscle-invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC)
Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Received prior systemic anticancer therapy including investigational agents within 3 years prior to randomization
Received any prior radiotherapy to the bladder
Received a partial cystectomy of the bladder to remove any non-muscle-invasive bladder cancer (NMIBC) or MIBC
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention
Ongoing sensory or motor neuropathy Grade 2 or higher
Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients
Severe hypersensitivity (≥ Grade 3) to enfortumab vedotin or any excipient contained in the drug formulation of enfortumab vedotin
Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator
Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed
Has uncontrolled diabetes
History of (noninfectious) pneumonitis that required steroids, or current pneumonitis
Active infection requiring systemic therapy
Has had an allogeneic tissue/solid organ transplant

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

857

Study ID:

NCT03924895

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 241 Locations for this study

See Locations Near You

University of South Alabama, Mitchell Cancer Institute ( Site 1582)
Mobile Alabama, 36604, United States
CARTI Cancer Center ( Site 1577)
Little Rock Arkansas, 72205, United States
St. Joseph Heritage Healthcare ( Site 0046)
Fullerton California, 92835, United States
Scripps MD Anderson ( Site 0010)
La Jolla California, 92037, United States
Hoag Memorial Hospital Presbyterian ( Site 1595)
Newport Beach California, 92663, United States
John Wayne Cancer Institute ( Site 0075)
Santa Monica California, 90404, United States
University of Colorado Hospital ( Site 0098)
Aurora Colorado, 80045, United States
Georgetown University Medical Center ( Site 0022)
Washington District of Columbia, 20007, United States
Emory School of Medicine ( Site 0006)
Atlanta Georgia, 30322, United States
John H. Stroger Jr. Hospital of Cook County ( Site 1551)
Chicago Illinois, 60612, United States
University of Chicago ( Site 0068)
Chicago Illinois, 60637, United States
Parkview Cancer Institute ( Site 0077)
Fort Wayne Indiana, 46845, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
Indianapolis Indiana, 46202, United States
Wichita Urology Group ( Site 0059)
Wichita Kansas, 67226, United States
Tulane University School of Medicine ( Site 0088)
New Orleans Louisiana, 70112, United States
New England Cancer Specialists ( Site 0070)
Scarborough Maine, 04074, United States
Greater Baltimore Medical Center ( Site 0014)
Baltimore Maryland, 21204, United States
Dana-Farber Cancer Institute ( Site 1596)
Boston Massachusetts, 02215, United States
M Health Fairview Ridges Hospital ( Site 1555)
Burnsville Minnesota, 55337, United States
Morristown Medical Center ( Site 0015)
Morristown New Jersey, 07960, United States
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque New Mexico, 87106, United States
Northwell Health - Monter Cancer Center ( Site 0083)
Lake Success New York, 11042, United States
New York University Perlmutter Cancer Center ( Site 0008)
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai ( Site 0031)
New York New York, 10029, United States
Cleveland Clinic Main ( Site 1576)
Cleveland Ohio, 44195, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa Oklahoma, 74146, United States
Providence Portland Medical Center [Portland, OR] ( Site 0095)
Portland Oregon, 97213, United States
MidLantic Urology ( Site 0089)
Bala-Cynwyd Pennsylvania, 19004, United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University ( Site 1579)
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center ( Site 0055)
Philadelphia Pennsylvania, 19111, United States
Allegheny General Hospital ( Site 0048)
Pittsburgh Pennsylvania, 15212, United States
Bon Secours St. Francis Health System ( Site 1572)
Greenville South Carolina, 29607, United States
Carolina Urologic Research Center ( Site 0062)
Myrtle Beach South Carolina, 29572, United States
Urology Associates [Nashville, TN] ( Site 0053)
Nashville Tennessee, 37209, United States
Vanderbilt University Medical Center ( Site 0017)
Nashville Tennessee, 37232, United States
Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
Dallas Texas, 75246, United States
Inova Schar Cancer Institute ( Site 0007)
Fairfax Virginia, 22031, United States
Charleston Area Medical Center ( Site 0023)
Charleston West Virginia, 25304, United States
Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)
Buenos Aires Caba, C1419, Argentina
Western Sydney Local Health District ( Site 1259)
Blacktown New South Wales, 2148, Australia
Macquarie University ( Site 1251)
Macquarie Park New South Wales, 2109, Australia
Cairns Base Hospital ( Site 1257)
Cairns Queensland, 4870, Australia
Mater Misericordiae Ltd ( Site 1258)
South Brisbane Queensland, 4101, Australia
Eastern Health ( Site 1255)
Box Hill Victoria, 3128, Australia
Monash Health ( Site 1260)
Clayton Victoria, 3168, Australia
UCL Saint-Luc - Oncologie Medicale ( Site 0357)
Bruxelles Bruxelles-Capitale, Region De, 1200, Belgium
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir Namur, 5530, Belgium
AZ Maria Middelares Gent ( Site 0353)
Gent Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 0361)
Leuven Vlaams-Brabant, 3000, Belgium
AZ Sint-Jan Brugge ( Site 0352)
Brugge West-Vlaanderen, 8000, Belgium
AZ Delta vzw-Oncology ( Site 0362)
Roeselare West-Vlaanderen, 8800, Belgium
Tom Baker Cancer Centre ( Site 0100)
Calgary Alberta, T2N 4, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)
Vancouver British Columbia, V5Z 4, Canada
Silverado Resarch Inc. ( Site 0111)
Victoria British Columbia, V8T 2, Canada
Moncton Hospital - Horizon Health Network ( Site 0112)
Moncton New Brunswick, E1C 6, Canada
Sunnybrook Research Institute ( Site 0110)
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto Ontario, M5G 2, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
Chicoutimi Quebec, G7H 5, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal Quebec, H1T 2, Canada
Jewish General Hospital ( Site 0120)
Montreal Quebec, H3T 1, Canada
McGill University Health Centre ( Site 0123)
Montréal Quebec, H4A 3, Canada
CIUSSS de l'Estrie-CHUS ( Site 0106)
Sherbrooke Quebec, J1H 5, Canada
Fundación Colombiana de Cancerología Clínica Vida ( Site 2003)
Medellin Antioquia, 05003, Colombia
Oncomédica S.A.S ( Site 2001)
Montería Cordoba, 23000, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2002)
Bogota Distrito Capital De Bogota, 11132, Colombia
Fundación Cardiovascular de Colombia ( Site 2004)
Piedecuesta Santander, 68101, Colombia
Fundacion Valle del Lili- CIC-Fundacion Valle del Lili ( Site 2005)
Cali Valle Del Cauca, 76003, Colombia
Herlev og Gentofte Hospital. ( Site 0412)
Herlev Hovedstaden, 2730, Denmark
Rigshospitalet University Hospital ( Site 0411)
Kobenhavn Hovedstaden, 2100, Denmark
Aarhus University Hospital Skejby ( Site 0418)
Aarhus Midtjylland, 8200, Denmark
Odense Universitetshospital ( Site 0413)
Odense Syddanmark, 5000, Denmark
Hopital de la Timone ( Site 0489)
Marseille Bouches-du-Rhone, 13005, France
Centre Francois Baclesse ( Site 0459)
Caen Calvados, 14075, France
Centre Georges Francois Leclerc ( Site 0488)
Dijon Cote-d Or, 21000, France
CHU Jean Minjoz ( Site 0455)
Besancon Doubs, 25000, France
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
Nimes Gard, 30029, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux Gironde, 33075, France
Institut Claudius Regaud IUCT Oncopole ( Site 0486)
Toulouse Haute-Garonne, 31059, France
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
Rennes Ille-et-Vilaine, 35033, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier Languedoc-Roussillon, 34295, France
CHU Hotel Dieu Nantes ( Site 0458)
Nantes Loire-Atlantique, 44093, France
Hopital Belle Isle ( Site 0452)
Vantoux Moselle, 57070, France
C.H.U. Lyon Sud ( Site 0466)
Pierre Benite Rhone, 69310, France
Institut Gustave Roussy ( Site 0487)
Villejuif Val-de-Marne, 94805, France
CHU Cochin ( Site 0475)
Paris , 75014, France
Hopital Europeen Georges Pompidou ( Site 0476)
Paris , 75015, France
Hopital Bichat du Paris ( Site 0462)
Paris , 75018, France
Klinikum Stuttgart - Katharinenhospital ( Site 0520)
Stuttgart Baden-Wurttemberg, 70174, Germany
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
Tuebingen Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Erlangen ( Site 0546)
Erlangen Bayern, 91058, Germany
Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
Muenchen Bayern, 81377, Germany
Universitaetsklinikum Wuerzburg ( Site 0547)
Wuerzburg Bayern, 97080, Germany
Universitaetsklinikum Bonn ( Site 0550)
Bonn Nordrhein-Westfalen, 53127, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
Magdeburg Sachsen-Anhalt, 39120, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0532)
Dresden Sachsen, 01307, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)
Gera Thuringen, 07548, Germany
Vivantes Klinikum am Urban ( Site 0529)
Berlin , 10967, Germany
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)
Hamburg , 20246, Germany
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged Csongrad, 6720, Hungary
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest , 1106, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen , 4032, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Gyor , 9023, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvar , 7400, Hungary
Tallaght University Hospital ( Site 0734)
Dublin , D24 N, Ireland
University Hospital Waterford ( Site 0747)
Waterford , X91ER, Ireland
Ha Emek Medical Center ( Site 0843)
Afula , 18341, Israel
Soroka Medical Center ( Site 0849)
Beer Sheva , 84101, Israel
Rambam Health Care Campus-Oncology Division ( Site 0845)
Haifa , 31096, Israel
Shaare Zedek Medical Center ( Site 0842)
Jerusalem , 91031, Israel
Hadassah Ein Kerem Medical Center ( Site 0841)
Jerusalem , 91120, Israel
Meir Medical Center ( Site 0846)
Kfar Saba , 44281, Israel
Rabin Medical Center ( Site 0847)
Petach Tikva , 49414, Israel
Sheba Medical Center ( Site 0844)
Ramat Gan , 52656, Israel
Sourasky Medical Center ( Site 0850)
Tel Aviv , 64239, Israel
Yitzhak Shamir Medical Center. ( Site 0848)
Zerifin , 70300, Israel
Policlinico Gemelli di Roma ( Site 0558)
Roma Abruzzo, 00168, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0561)
Milano Lombardia, 20132, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)
Orbassano Piemonte, 10043, Italy
AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
Vicenza Veneto, 36100, Italy
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)
Arezzo , 52100, Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania , 95123, Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano , 20133, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli , 80131, Italy
Fondazione Salvatore Maugeri IRCCS ( Site 0554)
Pavia , 27100, Italy
Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)
Terni , 05100, Italy
National Cancer Center Hospital East ( Site 2305)
Kashiwa Chiba, 277-8, Japan
Tsukuba University Hospital ( Site 2302)
Tsukuba Ibaraki, 305-8, Japan
St. Marianna University Hospital ( Site 2321)
Kawasaki Kanagawa, 216-8, Japan
Kitasato University Hospital ( Site 2306)
Sagamihara Kanagawa, 252-0, Japan
Yokosukakyosai ( Site 2307)
Yokosuka Kanagawa, 238-8, Japan
Tohoku University Hospital ( Site 2301)
Sendai-shi Miyagi, 980-8, Japan
Nagano Municipal Hospital ( Site 2309)
Tomitake Nagano, 381-8, Japan
Nara Medical University Hospital ( Site 2312)
Kashihara Nara, 634-0, Japan
Osaka Rosai Hospital ( Site 2320)
Sakai Osaka, 591-8, Japan
Saitama Prefectural Cancer Center ( Site 2319)
Ina-machi Saitama, 362-0, Japan
Dokkyo Medical University Saitama Medical Center ( Site 2304)
Koshigaya Saitama, 34385, Japan
Hamamatsu University Hospital ( Site 2311)
Hamamatsu Shizuoka, 431-3, Japan
Tokyo Medical and Dental University Hospital ( Site 2303)
Bunkyō Tokyo, 113-8, Japan
Toranomon Hospital ( Site 2322)
Minato-ku Tokyo, 105-8, Japan
Toyama University Hospital ( Site 2308)
Toyoma Toyama, 930-0, Japan
Gifu University Hospital ( Site 2310)
Gifu , 501-1, Japan
Kagoshima University Hospital ( Site 2317)
Kagoshima , 890-8, Japan
Nagasaki University Hospital ( Site 2315)
Nagasaki , 852-8, Japan
National Cancer Center ( Site 1354)
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Asan Medical Center ( Site 1355)
Songpagu Seoul, 05505, Korea, Republic of
Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of
Korea University Anam Hospital ( Site 1351)
Seoul , 02841, Korea, Republic of
Seoul National University Hospital ( Site 1352)
Seoul , 03080, Korea, Republic of
Samsung Medical Center ( Site 1353)
Seoul , 06351, Korea, Republic of
University Malaya Medical Centre ( Site 1702)
Lembah Pantai Kuala Lumpur, 59100, Malaysia
Hospital Pulau Pinang ( Site 1703)
Georgetown Pulau Pinang, 10990, Malaysia
Sarawak General Hospital ( Site 1701)
Kuching Sarawak, 93586, Malaysia
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
Monterrey Nuevo Leon, 66269, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes , 20010, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
Chihuahua , 31000, Mexico
Instituto Nacional de Cancerologia. ( Site 0256)
Ciudad de Mexico , 14080, Mexico
Centro de Tratamiento de Cancer ( Site 0266)
Metepec , 52140, Mexico
Hospital Angeles Roma ( Site 0262)
Mexico City , 06700, Mexico
THE MEDICAL CITY ILOILO ( Site 1756)
Iloilo City Iloilo, 5000, Philippines
The Medical City ( Site 1752)
Pasig City National Capital Region, 1605, Philippines
St. Luke s Medical Center ( Site 1751)
Quezon City National Capital Region, 1112, Philippines
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
Wroclaw Dolnoslaskie, 50-55, Poland
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Szpital Wojewodzki ( Site 1062)
Tarnow Malopolskie, 33-10, Poland
Europejskie Centrum Zdrowia Otwock ( Site 1058)
Otwock Mazowieckie, 05-40, Poland
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa Mazowieckie, 01-74, Poland
Bialostockie Centrum Onkologii ( Site 1072)
Bialystok Podlaskie, 15-02, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
Slupsk Pomorskie, 76-20, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
Bielsko-Biala Slaskie, 43-30, Poland
Clinical Research Center Medic-R ( Site 1073)
Poznań Wielkopolskie, 60-84, Poland
Clinic of Bashkortostan State Medical University ( Site 0873)
Ufa Baskortostan, Respublika, 45008, Russian Federation
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo Ivanovskaya Oblast, 15304, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk Kurskaya Oblast, 30552, Russian Federation
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
Moscow Moskva, 11547, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
Moscow Moskva, 11999, Russian Federation
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow Moskva, 12135, Russian Federation
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk Murmanskaya Oblast, 18305, Russian Federation
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk Omskaya Oblast, 64401, Russian Federation
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg Sankt-Peterburg, 18866, Russian Federation
First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
Saint-Petersburg Sankt-Peterburg, 19702, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Clinical Hospital Saint Luka ( Site 0867)
St. Petersburg Sankt-Peterburg, 19404, Russian Federation
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov Saratovskaya Oblast, 41001, Russian Federation
Sverdlovsk Regional Oncology Hospital ( Site 0874)
Ekaterinburg Sverdlovskaya Oblast, 62003, Russian Federation
Medical Sanitary Unit Neftyannik ( Site 0888)
Tyumen Tyumenskaya Oblast, 62500, Russian Federation
National University Hospital ( Site 1802)
Singapore Central Singapore, 11907, Singapore
Tan Tock Seng Hospital ( Site 1804)
Singapore Central Singapore, 39844, Singapore
Steve Biko Academic Hospital-Medical Oncology ( Site 1601)
Pretoria Gauteng, 0001, South Africa
Groote Schuur Hospital ( Site 1602)
Cape Town Western Cape, 7925, South Africa
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
Badalona Barcelona, 08916, Spain
Hospital Clinic i Provincial ( Site 0674)
Barcelona Cataluna, 08036, Spain
Hospital San Pedro de Alcantara ( Site 0697)
Caceres Extremadura, 10003, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 0700)
Girona Gerona, 17007, Spain
Hospital Universitario Quiron Madrid ( Site 0694)
Pozuelo de Alarcon Madrid, Comunidad De, 28223, Spain
Instituto Valenciano de Oncologia - IVO ( Site 0679)
Valencia Valenciana, Comunitat, 46009, Spain
Hospital del Mar ( Site 0698)
Barcelona , 08003, Spain
Hospital Universitario Ramon y Cajal ( Site 0691)
Madrid , 28034, Spain
Hospital Universitario San Carlos ( Site 0678)
Madrid , 28040, Spain
Hospital Universitario la Paz ( Site 0690)
Madrid , 28046, Spain
Hospital de Nuestra Senora de Valme ( Site 0693)
Sevilla , 41014, Spain
Laenssjukhuset Ryhov ( Site 1215)
Jonkoping Jonkopings Lan, 551 8, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1212)
Stockholm Stockholms Lan, 171 7, Sweden
Akademiska Sjukhuset ( Site 1211)
Uppsala Uppsala Lan, 751 8, Sweden
Cancercentrum ( Site 1214)
Umea Vasterbottens Lan, 901 8, Sweden
Onkologiska kliniken ( Site 1217)
Goteborg Vastra Gotalands Lan, 413 4, Sweden
Ramathibodi Hospital. ( Site 1451)
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai , 50200, Thailand
Srinagarind Hospital ( Site 1454)
Khon Kaen , 40002, Thailand
Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
Ankara , 06100, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
Istanbul , 34096, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
Istanbul , 34722, Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
Istanbul , 34899, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
Konya , 42080, Turkey
Sakarya Universitesi Tip Fakultesi ( Site 0933)
Sakarya , 54290, Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
Trabzon , 61080, Turkey
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy Cherkaska Oblast, 18009, Ukraine
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 0963)
Dnipropetrovsk Dnipropetrovska Oblast, 49005, Ukraine
MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 0951)
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Regional Oncology Center of Kharkiv ( Site 0958)
Kharkiv Kharkivska Oblast, 61000, Ukraine
MNPE V.I. Shapoval Regional Medical Clinical Urology and Nephrology Center of KharkivRegCouncil ( Si
Kharkiv Kharkivska Oblast, 61037, Ukraine
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
Kharkiv Kharkivska Oblast, 61166, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
Antonivka Village Khersonska Oblast, 73000, Ukraine
SNPE National Cancer Institute ( Site 0962)
Kyiv Kyivska Oblast, 03022, Ukraine
MNPE Lviv Regional Clinical Hospital of Lviv Regional Council ( Site 0955)
Lviv Lvivska Oblast, 79010, Ukraine
Lviv State Regional Oncological Center ( Site 0967)
Lviv Lvivska Oblast, 79031, Ukraine
Zhytomyr Regional Oncology Center ( Site 0971)
Zhytomyr Zhytomyrska Oblast, 10002, Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv , 03115, Ukraine
Kent and Canterbury Hospital ( Site 0733)
Canterbury England, CT1 3, United Kingdom
The James Cook University Hospital ( Site 0730)
Middlesbrough England, TS4 3, United Kingdom
Lister Hospital ( Site 0739)
Stevenage Hertfordshire, SG1 4, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
London London, City Of, EC1A , United Kingdom
The Royal Marsden Foundation Trust ( Site 0726)
London London, City Of, SW3 6, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0745)
London London, City Of, W6 8R, United Kingdom
Western General Hospital ( Site 0749)
Edinburgh Midlothian, EH4 2, United Kingdom
Royal Cornwall Hospital ( Site 0727)
Truro , TR1 3, United Kingdom
Walsall Manor Hospital-Oncology ( Site 0743)
Walsall , WS2 9, United Kingdom
Clatterbridge Oncology Centre ( Site 0731)
Wirral , CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

857

Study ID:

NCT03924895

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

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