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)
NCT ID: NCT03924895
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
595 participants
INTERVENTIONAL
2019-07-24
2027-12-15
Brief Summary
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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 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.
With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Arm B: Surgery alone
Participants receive standard of care surgery alone.
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Enfortumab Vedotin
Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Interventions
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Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Enfortumab Vedotin
Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Has ≥ N2 or metastatic disease (M1) as identified by imaging
* Received any prior systemic treatment, chemoradiation, and/or radiation therapy 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
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of South Alabama, Mitchell Cancer Institute ( Site 1582)
Mobile, Alabama, United States
CARTI Cancer Center ( Site 1577)
Little Rock, Arkansas, United States
St. Joseph Heritage Healthcare ( Site 0046)
Fullerton, California, United States
Scripps MD Anderson ( Site 0010)
La Jolla, California, United States
Hoag Memorial Hospital Presbyterian ( Site 1595)
Newport Beach, California, United States
John Wayne Cancer Institute ( Site 0075)
Santa Monica, California, United States
University of Colorado Hospital ( Site 0098)
Aurora, Colorado, United States
Georgetown University Medical Center ( Site 0022)
Washington D.C., District of Columbia, United States
Emory School of Medicine ( Site 0006)
Atlanta, Georgia, United States
John H. Stroger Jr. Hospital of Cook County ( Site 1551)
Chicago, Illinois, United States
University of Chicago ( Site 0068)
Chicago, Illinois, United States
Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
Indianapolis, Indiana, United States
Wichita Urology Group ( Site 0059)
Wichita, Kansas, United States
Tulane University School of Medicine ( Site 0088)
New Orleans, Louisiana, United States
New England Cancer Specialists ( Site 0070)
Westbrook, Maine, United States
Greater Baltimore Medical Center ( Site 0014)
Baltimore, Maryland, United States
Dana-Farber Cancer Institute ( Site 1596)
Boston, Massachusetts, United States
M Health Fairview Ridges Hospital ( Site 1555)
Burnsville, Minnesota, United States
Morristown Medical Center ( Site 0015)
Morristown, New Jersey, United States
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque, New Mexico, United States
Northwell Health - Monter Cancer Center ( Site 0083)
Lake Success, New York, United States
New York University Perlmutter Cancer Center ( Site 0008)
New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0031)
New York, New York, United States
Cleveland Clinic Main ( Site 1576)
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma, United States
Providence Portland Medical Center [Portland, OR] ( Site 0095)
Portland, Oregon, United States
MidLantic Urology ( Site 0089)
Bala-Cynwyd, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
Philadelphia, Pennsylvania, United States
Thomas Jefferson University ( Site 1579)
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0055)
Philadelphia, Pennsylvania, United States
Allegheny General Hospital ( Site 0048)
Pittsburgh, Pennsylvania, United States
Bon Secours St. Francis Health System ( Site 1572)
Greenville, South Carolina, United States
Carolina Urologic Research Center ( Site 0062)
Myrtle Beach, South Carolina, United States
Urology Associates [Nashville, TN] ( Site 0053)
Nashville, Tennessee, United States
Vanderbilt University Medical Center ( Site 0017)
Nashville, Tennessee, United States
Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
Dallas, Texas, United States
Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia, United States
Charleston Area Medical Center ( Site 0023)
Charleston, West Virginia, United States
Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)
Buenos Aires, Buenos Aires F.D., Argentina
Western Sydney Local Health District ( Site 1259)
Blacktown, New South Wales, Australia
Macquarie University ( Site 1251)
Macquarie Park, New South Wales, Australia
Cairns Base Hospital ( Site 1257)
Cairns, Queensland, Australia
Mater Misericordiae Ltd ( Site 1258)
South Brisbane, Queensland, Australia
Eastern Health ( Site 1255)
Box Hill, Victoria, Australia
Monash Health ( Site 1260)
Clayton, Victoria, Australia
UCL Saint-Luc - Oncologie Medicale ( Site 0357)
Brussels, Bruxelles-Capitale, Region de, Belgium
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir, Namur, Belgium
AZ Maria Middelares Gent ( Site 0353)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0361)
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan Brugge ( Site 0352)
Bruges, West-Vlaanderen, Belgium
AZ Delta vzw-Oncology ( Site 0362)
Roeselare, West-Vlaanderen, Belgium
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0100)
Calgary, Alberta, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)
Vancouver, British Columbia, Canada
Silverado Resarch Inc. ( Site 0111)
Victoria, British Columbia, Canada
Moncton Hospital - Horizon Health Network ( Site 0112)
Moncton, New Brunswick, Canada
Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
Chicoutimi, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0120)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0123)
Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS ( Site 0106)
Sherbrooke, Quebec, Canada
Fundacion Colombiana de Cancerología Clinica Vida ( Site 2003)
Medellín, Antioquia, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2002)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 2001)
Montería, Departamento de Córdoba, Colombia
Fundación Cardiovascular de Colombia ( Site 2004)
Piedecuesta, Santander Department, Colombia
Fundacion Valle del Lili- CIC-Fundacion Valle del Lili ( Site 2005)
Cali, Valle del Cauca Department, Colombia
Rigshospitalet University Hospital ( Site 0411)
Copenhagen, Capital Region, Denmark
Herlev og Gentofte Hospital. ( Site 0412)
Herlev, Capital Region, Denmark
Aarhus University Hospital Skejby ( Site 0418)
Aarhus, Central Jutland, Denmark
Odense Universitetshospital ( Site 0413)
Odense, Region Syddanmark, Denmark
Hopital de la Timone ( Site 0489)
Marseille, Bouches-du-Rhone, France
Centre Georges Francois Leclerc ( Site 0488)
Dijon, Bourgogne-Franche-Comté, France
Centre Francois Baclesse ( Site 0459)
Caen, Calvados, France
CHU Jean Minjoz ( Site 0455)
Besançon, Doubs, France
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
Nîmes, Gard, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux, Gironde, France
Institut Claudius Regaud IUCT Oncopole ( Site 0486)
Toulouse, Haute-Garonne, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Herault, France
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
Rennes, Ille-et-Vilaine, France
CHU Hotel Dieu Nantes ( Site 0458)
Nantes, Loire-Atlantique, France
Hopital Belle Isle ( Site 0452)
Vantoux, Moselle, France
C.H.U. Lyon Sud ( Site 0466)
Pierre-Bénite, Rhone, France
Institut Gustave Roussy ( Site 0487)
Villejuif, Val-de-Marne, France
CHU Cochin ( Site 0475)
Paris, , France
Hopital Europeen Georges Pompidou ( Site 0476)
Paris, , France
Hopital Bichat du Paris ( Site 0462)
Paris, , France
Klinikum Stuttgart - Katharinenhospital ( Site 0520)
Stuttgart, Baden-Wurttemberg, Germany
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 0546)
Erlangen, Bavaria, Germany
Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
Munich, Bavaria, Germany
Universitaetsklinikum Wuerzburg ( Site 0547)
Würzburg, Bavaria, Germany
Universitaetsklinikum Bonn ( Site 0550)
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0532)
Dresden, Saxony, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
Magdeburg, Saxony-Anhalt, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)
Gera, Thuringia, Germany
Vivantes Klinikum am Urban ( Site 0529)
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)
Hamburg, , Germany
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Csongrád megye, Hungary
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Győr, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvár, , Hungary
Tallaght University Hospital ( Site 0734)
Dublin, , Ireland
University Hospital Waterford ( Site 0747)
Waterford, , Ireland
Ha Emek Medical Center ( Site 0843)
Afula, , Israel
Soroka Medical Center ( Site 0849)
Beersheba, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0845)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 0842)
Jerusalem, , Israel
Hadassah Ein Kerem Medical Center ( Site 0841)
Jerusalem, , Israel
Meir Medical Center ( Site 0846)
Kfar Saba, , Israel
Rabin Medical Center ( Site 0847)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0844)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0850)
Tel Aviv, , Israel
Yitzhak Shamir Medical Center. ( Site 0848)
Ẕerifin, , Israel
Policlinico Gemelli di Roma ( Site 0558)
Roma, Abruzzo, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)
Orbassano, Piedmont, Italy
AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
Vicenza, Veneto, Italy
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)
Arezzo, , Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, , Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0561)
Milan, , Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milan, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, , Italy
Fondazione Salvatore Maugeri IRCCS ( Site 0554)
Pavia, , Italy
Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)
Terni, , Italy
National Cancer Center Hospital East ( Site 2305)
Kashiwa, Chiba, Japan
University of Tsukuba Hospital ( Site 2302)
Tsukuba, Ibaraki, Japan
St. Marianna University Hospital ( Site 2321)
Kawasaki, Kanagawa, Japan
Kitasato University Hospital ( Site 2306)
Sagamihara, Kanagawa, Japan
Yokosuka Kyosai Hospital ( Site 2307)
Yokosuka, Kanagawa, Japan
Tohoku University Hospital ( Site 2301)
Sendai, Miyagi, Japan
Nagano Municipal Hospital ( Site 2309)
Tomitake, Nagano, Japan
Nara Medical University Hospital ( Site 2312)
Kashihara, Nara, Japan
Osaka Rosai Hospital ( Site 2320)
Sakai, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 2319)
Ina-machi, Saitama, Japan
Dokkyo Medical University Saitama Medical Center ( Site 2304)
Koshigaya, Saitama, Japan
Hamamatsu University Hospital ( Site 2311)
Hamamatsu, Shizuoka, Japan
Institute of Science Tokyo Hospital ( Site 2303)
Bunkyō, Tokyo, Japan
Toranomon Hospital ( Site 2322)
Minato-ku, Tokyo, Japan
Toyama University Hospital ( Site 2308)
Toyoma, Toyama, Japan
Gifu University Hospital ( Site 2310)
Gifu, , Japan
Kagoshima University Hospital ( Site 2317)
Kagoshima, , Japan
Nagasaki University Hospital ( Site 2315)
Nagasaki, , Japan
University Malaya Medical Centre ( Site 1702)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 1703)
George Town, Pulau Pinang, Malaysia
Sarawak General Hospital ( Site 1701)
Kuching, Sarawak, Malaysia
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
Monterrey, Nuevo León, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes, , Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
Chihuahua City, , Mexico
Centro de Tratamiento de Cancer ( Site 0266)
Metepec, , Mexico
Hospital Angeles Roma ( Site 0262)
Mexico City, , Mexico
Instituto Nacional de Cancerologia. ( Site 0256)
Mexico City, , Mexico
THE MEDICAL CITY ILOILO ( Site 1756)
Iloilo City, Iloilo, Philippines
The Medical City ( Site 1752)
Pasig, National Capital Region, Philippines
St. Luke s Medical Center ( Site 1751)
Quezon City, National Capital Region, Philippines
Clinical Research Center Medic-R ( Site 1073)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Wojewodzki ( Site 1062)
Tarnów, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
Wroclaw, Lower Silesian Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock ( Site 1058)
Otwock, Masovian Voivodeship, Poland
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warsaw, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 1072)
Bialystok, Podlaskie Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
Słupsk, Pomeranian Voivodeship, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
Bielsko-Biala, Silesian Voivodeship, Poland
Clinic of Bashkortostan State Medical University ( Site 0873)
Ufa, Baskortostan, Respublika, Russia
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo, Ivanovo Oblast, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk, Kursk Oblast, Russia
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
Moscow, Moscow, Russia
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
Moscow, Moscow, Russia
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow, Moscow, Russia
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk, Murmansk Oblast, Russia
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk, Omsk Oblast, Russia
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg, Sankt-Peterburg, Russia
Clinical Hospital Saint Luka ( Site 0867)
Saint Petersburg, Sankt-Peterburg, Russia
First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
Saint Petersburg, Sankt-Peterburg, Russia
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
Saint Petersburg, Sankt-Peterburg, Russia
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov, Saratov Oblast, Russia
Sverdlovsk Regional Oncology Hospital ( Site 0874)
Yekaterinburg, Sverdlovsk Oblast, Russia
Medical Sanitary Unit Neftyannik ( Site 0888)
Tyumen, Tyumen Oblast, Russia
National University Hospital ( Site 1802)
Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital ( Site 1804)
Singapore, Central Singapore, Singapore
Steve Biko Academic Hospital-Medical Oncology ( Site 1601)
Pretoria, Gauteng, South Africa
Groote Schuur Hospital ( Site 1602)
Cape Town, Western Cape, South Africa
National Cancer Center ( Site 1354)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 1355)
Songpagu, Seoul, South Korea
Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
Deagu, Taegu-Kwangyokshi, South Korea
Korea University Anam Hospital ( Site 1351)
Seoul, , South Korea
Seoul National University Hospital ( Site 1352)
Seoul, , South Korea
Samsung Medical Center ( Site 1353)
Seoul, , South Korea
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
Badalona, Barcelona, Spain
Hospital Clinic i Provincial ( Site 0674)
Barcelona, Catalonia, Spain
Hospital San Pedro de Alcantara ( Site 0697)
Cáceres, Extremadura, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 0700)
Girona, Gerona, Spain
Hospital Universitario Quiron Madrid ( Site 0694)
Pozuelo de Alarcón, Madrid, Comunidad de, Spain
Instituto Valenciano de Oncologia - IVO ( Site 0679)
Valencia, Valenciana, Comunitat, Spain
Hospital del Mar ( Site 0698)
Barcelona, , Spain
Hospital Universitario Ramon y Cajal ( Site 0691)
Madrid, , Spain
Hospital Universitario San Carlos ( Site 0678)
Madrid, , Spain
Hospital Universitario la Paz ( Site 0690)
Madrid, , Spain
Hospital de Nuestra Senora de Valme ( Site 0693)
Seville, , Spain
Laenssjukhuset Ryhov ( Site 1215)
Jönköping, Jönköping County, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1212)
Stockholm, Stockholm County, Sweden
Akademiska Sjukhuset ( Site 1211)
Uppsala, Uppsala County, Sweden
Cancercentrum ( Site 1214)
Umeå, Västerbotten County, Sweden
Onkologiska kliniken ( Site 1217)
Gothenburg, Västra Götaland County, Sweden
Ramathibodi Hospital. ( Site 1451)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, , Thailand
Srinagarind Hospital ( Site 1454)
Khon Kaen, , Thailand
Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
Istanbul, , Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
Konya, , Turkey (Türkiye)
Sakarya Universitesi Tip Fakultesi ( Site 0933)
Sakarya, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
Trabzon, , Turkey (Türkiye)
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy, Cherkasy Oblast, Ukraine
MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 0951)
Dnipro, Dnipropetrovsk Oblast, Ukraine
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 0963)
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Regional Oncology Center of Kharkiv ( Site 0958)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
MNPE V.I. Shapoval Regional Medical Clinical Urology and Nephrology Center of KharkivRegCouncil ( Site 0969)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 0976)
Antonivka Village, Kherson Oblast, Ukraine
SNPE National Cancer Institute ( Site 0962)
Kyiv, Kyivska Oblast, Ukraine
MNPE Lviv Regional Clinical Hospital of Lviv Regional Council ( Site 0955)
Lviv, Lviv Oblast, Ukraine
Lviv State Regional Oncological Center ( Site 0967)
Lviv, Lviv Oblast, Ukraine
Zhytomyr Regional Oncology Center ( Site 0971)
Zhytomyr, Zhytomyr Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv, , Ukraine
Walsall Manor Hospital-Oncology ( Site 0743)
Walsall, Devon, United Kingdom
Kent and Canterbury Hospital ( Site 0733)
Canterbury, England, United Kingdom
The James Cook University Hospital ( Site 0730)
Middlesbrough, England, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0745)
London, Hammersmith and Fulham, United Kingdom
Lister Hospital ( Site 0739)
Stevenage, Hertfordshire, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
London, London, City of, United Kingdom
The Royal Marsden Foundation Trust ( Site 0726)
London, London, City of, United Kingdom
Western General Hospital ( Site 0749)
Edinburgh, Midlothian, United Kingdom
Clatterbridge Oncology Centre ( Site 0731)
Metropolitan Borough of Wirral, , United Kingdom
Royal Cornwall Hospital ( Site 0727)
Truro, , United Kingdom
Countries
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References
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Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-905
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-905
Identifier Type: OTHER
Identifier Source: secondary_id
EV-303
Identifier Type: OTHER
Identifier Source: secondary_id
PHRR210911-003890
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031220686
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-504932-16
Identifier Type: REGISTRY
Identifier Source: secondary_id
2031220686
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-4057
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-003809-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-905
Identifier Type: -
Identifier Source: org_study_id
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