Clinical trial NCT03924895: 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)
Official title: A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urinary Bladder Cancer, Muscle-invasive
Keywords: Muscle-Invasive Bladder Cancer (MIBC)
Enfortumab vedotin (EV)
Pembrolizumab (MK-3475)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Seagen Inc.
name: Astellas Pharma Global Development, Inc.
First posted: 2019-04-23
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


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 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

Primary outcomes:
measure: Event-Free Survival (EFS) between Arm C and Arm B
timeFrame: Up to approximately 6.75 years
Secondary outcomes:
measure: EFS between Arm A and Arm B
timeFrame: Up to approximately 6.75 years
measure: Overall Survival (OS) between Arm C and Arm B
timeFrame: Up to approximately 7.6 years
measure: OS between Arm A and Arm B
timeFrame: Up to approximately 7.6 years
measure: Pathologic Complete Response (pCR) Rate between Arm C and Arm B
timeFrame: Up to approximately 5.7 years
measure: pCR Rate between Arm A and Arm B
timeFrame: Up to approximately 5.7 years
measure: Disease-Free Survival (DFS)
timeFrame: Up to approximately 6.75 years
measure: Pathologic Downstaging (pDS) Rate between Arm A and Arm B
timeFrame: Up to approximately 5.7 years
measure: pDS Rate between Arm C and Arm B
timeFrame: Up to approximately 5.7 years
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 7.6 years
measure: Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)
timeFrame: Up to approximately 1 year
measure: Number of Participants Experiencing Perioperative Complications
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 1582)
state: Alabama
city: Little Rock
country: United States
facility: CARTI Cancer Center ( Site 1577)
state: Arkansas
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare ( Site 0046)
state: California
city: La Jolla
country: United States
facility: Scripps MD Anderson ( Site 0010)
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian ( Site 1595)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute ( Site 0075)
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital ( Site 0098)
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 0022)
state: District of Columbia
city: Atlanta
country: United States
facility: Emory School of Medicine ( Site 0006)
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County ( Site 1551)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago ( Site 0068)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute ( Site 0077)
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
state: Indiana
city: Wichita
country: United States
facility: Wichita Urology Group ( Site 0059)
state: Kansas
city: New Orleans
country: United States
facility: Tulane University School of Medicine ( Site 0088)
state: Louisiana
city: Westbrook
country: United States
facility: New England Cancer Specialists ( Site 0070)
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center ( Site 0014)
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute ( Site 1596)
state: Massachusetts
city: Burnsville
country: United States
facility: M Health Fairview Ridges Hospital ( Site 1555)
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center ( Site 0015)
state: New Jersey
city: Albuquerque
country: United States
facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
state: New Mexico
city: Lake Success
country: United States
facility: Northwell Health - Monter Cancer Center ( Site 0083)
state: New York
city: New York
country: United States
facility: New York University Perlmutter Cancer Center ( Site 0008)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0031)
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Main ( Site 1576)
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center [Portland, OR] ( Site 0095)
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology ( Site 0089)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University ( Site 1579)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 0055)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 0048)
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours St. Francis Health System ( Site 1572)
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center ( Site 0062)
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates [Nashville, TN] ( Site 0053)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ( Site 0017)
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0007)
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center ( Site 0023)
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)
state: Caba
city: Blacktown
country: Australia
facility: Western Sydney Local Health District ( Site 1259)
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University ( Site 1251)
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital ( Site 1257)
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd ( Site 1258)
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health ( Site 1255)
state: Victoria
city: Clayton
country: Australia
facility: Monash Health ( Site 1260)
state: Victoria
city: Bruxelles
country: Belgium
facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)
state: Bruxelles-Capitale, Region De
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site de Godinne ( Site 0354)
state: Namur
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent ( Site 0353)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0361)
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge ( Site 0352)
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta vzw-Oncology ( Site 0362)
state: West-Vlaanderen
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre ( Site 0100)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)
state: British Columbia
city: Victoria
country: Canada
facility: Silverado Resarch Inc. ( Site 0111)
state: British Columbia
city: Moncton
country: Canada
facility: Moncton Hospital - Horizon Health Network ( Site 0112)
state: New Brunswick
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0110)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0107)
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0120)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0123)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS ( Site 0106)
state: Quebec
city: Medellin
country: Colombia
facility: Fundacion Colombiana de Cancerología Clinica Vida ( Site 2003)
state: Antioquia
city: Montería
country: Colombia
facility: IMAT S.A.S ( Site 2001)
state: Cordoba
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2002)
state: Distrito Capital De Bogota
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia ( Site 2004)
state: Santander
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC-Fundacion Valle del Lili ( Site 2005)
state: Valle Del Cauca
city: Herlev
country: Denmark
facility: Herlev og Gentofte Hospital. ( Site 0412)
state: Hovedstaden
city: Kobenhavn
country: Denmark
facility: Rigshospitalet University Hospital ( Site 0411)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby ( Site 0418)
state: Midtjylland
city: Odense
country: Denmark
facility: Odense Universitetshospital ( Site 0413)
state: Syddanmark
city: Marseille
country: France
facility: Hopital de la Timone ( Site 0489)
state: Bouches-du-Rhone
city: Dijon
country: France
facility: Centre Georges Francois Leclerc ( Site 0488)
state: Bourgogne
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 0459)
state: Calvados
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0455)
state: Doubs
city: Nimes
country: France
facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
state: Gard
city: Bordeaux
country: France
facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0486)
state: Haute-Garonne
city: Montpellier
country: France
facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
state: Herault
city: Rennes
country: France
facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
state: Ille-et-Vilaine
city: Nantes
country: France
facility: CHU Hotel Dieu Nantes ( Site 0458)
state: Loire-Atlantique
city: Vantoux
country: France
facility: Hopital Belle Isle ( Site 0452)
state: Moselle
city: Pierre Benite
country: France
facility: C.H.U. Lyon Sud ( Site 0466)
state: Rhone
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0487)
state: Val-de-Marne
city: Paris
country: France
facility: CHU Cochin ( Site 0475)
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou ( Site 0476)
city: Paris
country: France
facility: Hopital Bichat du Paris ( Site 0462)
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Katharinenhospital ( Site 0520)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen ( Site 0546)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
state: Bayern
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg ( Site 0547)
state: Bayern
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn ( Site 0550)
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus ( Site 0532)
state: Sachsen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)
state: Thuringen
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban ( Site 0529)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)
city: Szeged
country: Hungary
facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
state: Csongrad
city: Budapest
country: Hungary
facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0734)
city: Waterford
country: Ireland
facility: University Hospital Waterford ( Site 0747)
city: Afula
country: Israel
facility: Ha Emek Medical Center ( Site 0843)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0849)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0845)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 0842)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0841)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0846)
city: Petach Tikva
country: Israel
facility: Rabin Medical Center ( Site 0847)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0844)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0850)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 0848)
city: Roma
country: Italy
facility: Policlinico Gemelli di Roma ( Site 0558)
state: Abruzzo
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)
state: Piemonte
city: Vicenza
country: Italy
facility: AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
state: Veneto
city: Arezzo
country: Italy
facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)
city: Milano
country: Italy
facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
city: Napoli
country: Italy
facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri IRCCS ( Site 0554)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2305)
state: Chiba
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 2302)
state: Ibaraki
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 2321)
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 2306)
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital ( Site 2307)
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital ( Site 2301)
state: Miyagi
city: Tomitake
country: Japan
facility: Nagano Municipal Hospital ( Site 2309)
state: Nagano
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 2312)
state: Nara
city: Sakai
country: Japan
facility: Osaka Rosai Hospital ( Site 2320)
state: Osaka
city: Ina-machi
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 2319)
state: Saitama
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center ( Site 2304)
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 2311)
state: Shizuoka
city: Bunkyō
country: Japan
facility: Institute of Science Tokyo Hospital ( Site 2303)
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital ( Site 2322)
state: Tokyo
city: Toyoma
country: Japan
facility: Toyama University Hospital ( Site 2308)
state: Toyama
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 2310)
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital ( Site 2317)
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital ( Site 2315)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 1354)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 1356)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 1355)
state: Seoul
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 1351)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1352)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1353)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 1702)
state: Kuala Lumpur
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang ( Site 1703)
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 1701)
state: Sarawak
city: Monterrey
country: Mexico
facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia. ( Site 0256)
city: Metepec
country: Mexico
facility: Centro de Tratamiento de Cancer ( Site 0266)
city: Mexico City
country: Mexico
facility: Hospital Angeles Roma ( Site 0262)
city: Iloilo City
country: Philippines
facility: THE MEDICAL CITY ILOILO ( Site 1756)
state: Iloilo
city: Pasig City
country: Philippines
facility: The Medical City ( Site 1752)
state: National Capital Region
city: Quezon City
country: Philippines
facility: St. Luke s Medical Center ( Site 1751)
state: National Capital Region
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
state: Kujawsko-pomorskie
city: Tarnow
country: Poland
facility: Szpital Wojewodzki ( Site 1062)
state: Malopolskie
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock ( Site 1058)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Luxmed Onkologia sp. z o. o. ( Site 1051)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 1072)
state: Podlaskie
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
state: Pomorskie
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
state: Slaskie
city: Poznań
country: Poland
facility: Clinical Research Center Medic-R ( Site 1073)
state: Wielkopolskie
city: Ufa
country: Russian Federation
facility: Clinic of Bashkortostan State Medical University ( Site 0873)
state: Baskortostan, Respublika
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary ( Site 0852)
state: Ivanovskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
state: Krasnoyarskiy Kray
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)
state: Kurskaya Oblast
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with outpatient Clinic ( Site 0856)
state: Moskva
city: Murmansk
country: Russian Federation
facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
state: Murmanskaya Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
state: Nizhegorodskaya Oblast
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 0865)
state: Omskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center ( Site 0868)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Clinical Hospital Saint Luka ( Site 0867)
state: Sankt-Peterburg
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
state: Saratovskaya Oblast
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Hospital ( Site 0874)
state: Sverdlovskaya Oblast
city: Tyumen
country: Russian Federation
facility: Medical Sanitary Unit Neftyannik ( Site 0888)
state: Tyumenskaya Oblast
city: Singapore
country: Singapore
facility: National University Hospital ( Site 1802)
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital ( Site 1804)
state: Central Singapore
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital-Medical Oncology ( Site 1601)
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital ( Site 1602)
state: Western Cape
city: Badalona
country: Spain
facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial ( Site 0674)
state: Cataluna
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara ( Site 0697)
state: Extremadura
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona ( Site 0700)
state: Gerona
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 0694)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 0698)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 0691)
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos ( Site 0678)
city: Madrid
country: Spain
facility: Hospital Universitario la Paz ( Site 0690)
city: Sevilla
country: Spain
facility: Hospital de Nuestra Senora de Valme ( Site 0693)
city: Jonkoping
country: Sweden
facility: Laenssjukhuset Ryhov ( Site 1215)
state: Jonkopings Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1212)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset ( Site 1211)
state: Uppsala Lan
city: Umea
country: Sweden
facility: Cancercentrum ( Site 1214)
state: Vasterbottens Lan
city: Goteborg
country: Sweden
facility: Onkologiska kliniken ( Site 1217)
state: Vastra Gotalands Lan
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital. ( Site 1451)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 1452)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital ( Site 1454)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Tip Fakultesi ( Site 0933)
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 0959)
state: Cherkaska Oblast
city: Dnipropetrovsk
country: Ukraine
facility: ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 0963)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 0951)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Oncology Center of Kharkiv ( Site 0958)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: MNPE V.I. Shapoval Regional Medical Clinical Urology and Nephrology Center of KharkivRegCouncil ( Site 0969)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
state: Kharkivska Oblast
city: Antonivka Village
country: Ukraine
facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 0976)
state: Khersonska Oblast
city: Kyiv
country: Ukraine
facility: SNPE National Cancer Institute ( Site 0962)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: MNPE Lviv Regional Clinical Hospital of Lviv Regional Council ( Site 0955)
state: Lvivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Regional Oncological Center ( Site 0967)
state: Lvivska Oblast
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Regional Oncology Center ( Site 0971)
state: Zhytomyrska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 0960)
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital-Oncology ( Site 0743)
state: Devon
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital ( Site 0733)
state: England
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital ( Site 0730)
state: England
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust ( Site 0745)
state: Hammersmith And Fulham
city: Stevenage
country: United Kingdom
facility: Lister Hospital ( Site 0739)
state: Hertfordshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Marsden Foundation Trust ( Site 0726)
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 0749)
state: Midlothian
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital ( Site 0727)
city: Wirral
country: United Kingdom
facility: Clatterbridge Oncology Centre ( Site 0731)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.