Clinical trial NCT03924856: Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
Official title: A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Pembrolizumab (MK-3475)
Chemotherapy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 907
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: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.


Eligibility criteria: Inclusion Criteria:

* Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
* Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
* Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
* Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
* Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
* Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
* Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
* Has a known psychiatric or substance abuse disorder.
* Has had an allogenic tissue/solid organ transplant.

Primary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: Up to approximately 60 months
Secondary outcomes:
measure: Pathologic Complete Response (pCR) Rate
timeFrame: Up to approximately 72 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 72 months
measure: Disease-Free Survival (DFS)
timeFrame: From approximately 20 weeks up to approximately 72 months
measure: Pathologic Downstaging (pDS) Rate
timeFrame: Up to approximately 72 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 72 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 12 months
measure: Number of Participants Who Experienced Perioperative Complications
timeFrame: Up to approximately 12 months
measure: Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Baseline, Up to approximately 72 months
measure: Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys)
timeFrame: Baseline, Up to approximately 72 months
measure: Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI)
timeFrame: Baseline, Up to approximately 72 months
measure: Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)
timeFrame: Baseline, Up to approximately 72 months
measure: Time to Deterioration (TTD) in the Total Score of FACT-G
timeFrame: Up to approximately 72 months
measure: TTD in EQ-5D-5L VAS
timeFrame: Up to approximately 72 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps MD Anderson ( Site 0010)
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center ( Site 0075)
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 0022)
state: District of Columbia
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
state: Florida
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 Cancer Center ( Site 0004)
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center ( Site 0049)
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 0070)
state: Maine
city: Worcester
country: United States
facility: UMass Memorial Medical Center ( Site 0051)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0039)
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis ( Site 0064)
state: Missouri
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: New York
country: United States
facility: New York University Perlmutter Cancer Center ( Site 0008)
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0038)
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: Portland VA Medical Center ( Site 0084)
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 0048)
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center ( Site 0063)
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Healthcare System ( Site 0057)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0007)
state: Virginia
city: Puyallup
country: United States
facility: Northwest Medical Specialties, PLLC ( Site 0061)
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
state: Washington
city: Charles Town
country: United States
facility: Charleston Area Medical Center ( Site 0023)
state: West Virginia
city: Port Macquarie
country: Australia
facility: Mid North Coast Cancer Institute ( Site 1256)
state: New South Wales
city: Sydney
country: Australia
facility: Southside Cancer Care Centre ( Site 1252)
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital ( Site 1257)
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health ( Site 1255)
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health Frankston Hospital ( Site 1258)
state: Victoria
city: Brussels
country: Belgium
facility: UZ Brussel ( Site 0358)
state: Bruxelles-Capitale, Region De
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis ( Site 0360)
state: Limburg
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site de Godinne ( Site 0354)
state: Namur
city: Aalst
country: Belgium
facility: O.L.V. Ziekenhuis Aalst ( Site 0356)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent ( Site 0353)
state: Oost-Vlaanderen
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0100)
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health Authority ( Site 0109)
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 0103)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 0104)
state: Ontario
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: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
state: Quebec
city: Herlev
country: Denmark
facility: Herlev og Gentofte Hospital. ( Site 0402)
state: Hovedstaden
city: Kobenhavn
country: Denmark
facility: Rigshospitalet University Hospital ( Site 0401)
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense Universitetshospital ( Site 0403)
state: Syddanmark
city: Bordeaux
country: France
facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
state: Aquitaine
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0465)
state: Auvergne
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 0459)
state: Calvados
city: Plerin
country: France
facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
state: Cotes-d Armor
city: Suresnes
country: France
facility: Hopital Foch ( Site 0483)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
state: Languedoc-Roussillon
city: Angers
country: France
facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
state: Maine-et-Loire
city: Metz
country: France
facility: Hopital Robert Schuman ( Site 0452)
state: Moselle
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin ( Site 0460)
state: Puy-de-Dome
city: Le Mans
country: France
facility: Clinique Victor Hugo ( Site 0463)
state: Sarthe
city: Rouen
country: France
facility: CHU de Rouen ( Site 0493)
state: Seine-Maritime
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0454)
state: Vaucluse
city: Tuebingen
country: Germany
facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen ( Site 0505)
state: Bayern
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus ( Site 0519)
state: Sachsen
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 0515)
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban ( Site 0522)
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem AOK ( Site 1009)
state: Baranya
city: Szeged
country: Hungary
facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
state: Csongrad
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
state: Jasz-Nagykun-Szolnok
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: Cork
country: Ireland
facility: Cork University Hospital ( Site 0722)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0710)
city: Waterford
country: Ireland
facility: University Hospital Waterford ( Site 0723)
city: Afula
country: Israel
facility: Ha Emek Medical Center ( Site 0808)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0806)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0802)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 0809)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0810)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0803)
city: Petach Tikva
country: Israel
facility: Rabin Medical Center ( Site 0804)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0801)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0807)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center ( Site 0805)
city: Roma
country: Italy
facility: Policlinico Gemelli di Roma ( Site 0558)
state: Abruzzo
city: Modena
country: Italy
facility: Policlinico di Modena ( Site 0553)
state: Emilia-Romagna
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
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: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni ( Site 0557)
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital ( Site 1502)
state: Aomori
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1504)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1508)
state: Ehime
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 1501)
state: Hokkaido
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 1503)
state: Ibaraki
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital ( Site 1509)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 1510)
state: Nara
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1505)
state: Saitama
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 1506)
city: Fukuoka
country: Japan
facility: Harasanshin Hospital ( Site 1515)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
city: Nagano
country: Japan
facility: Nagano Municipal Hospital ( Site 1516)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 1512)
city: Tokushima
country: Japan
facility: Tokushima University Hospital ( Site 1514)
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital ( Site 1517)
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: 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: Asan Medical Center ( Site 1355)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1353)
city: Monterrey
country: Mexico
facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
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 0253)
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cancerologia ( Site 0256)
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
state: Kujawsko-pomorskie
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock ( Site 1057)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Luxmed Onkologia sp. z o. o. ( Site 1051)
state: Mazowieckie
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
state: Slaskie
city: Ufa
country: Russian Federation
facility: Clinic of Bashkortostan State Medical University ( Site 0869)
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: FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
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: 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: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara ( Site 0654)
state: Extremadura
city: Girona
country: Spain
facility: H. de Gerona Dr. Josep Trueta ( Site 0651)
state: Gerona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 0660)
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 0657)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia - IVO ( Site 0662)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 0653)
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos ( Site 0663)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 0661)
city: Sevilla
country: Spain
facility: Hospital Nuestra Sra. de Valme ( Site 0658)
city: Jonkoping
country: Sweden
facility: Laenssjukhuset Ryhov ( Site 1205)
state: Jonkopings Lan
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset ( Site 1201)
state: Uppsala Lan
city: Umea
country: Sweden
facility: Cancercentrum ( Site 1204)
state: Vasterbottens 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 0911)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
city: Istanbul
country: Turkey
facility: Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Tip Fakultesi ( Site 0913)
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 0959)
state: Cherkaska Oblast
city: Dnipropetrovsk
country: Ukraine
facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Regional Oncological Hospital ( Site 0956)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: CNPE "Regional Center of Oncology" ( Site 0958)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital ( Site 0955)
state: Lvivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
state: Lvivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 0960)
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary ( Site 0708)
state: Aberdeen City
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 0704)
state: Devon
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital ( Site 0709)
state: England
city: Stevenage
country: United Kingdom
facility: Lister Hospital ( Site 0715)
state: Hertfordshire
city: London
country: United Kingdom
facility: The Royal Marsden Foundation Trust ( Site 0702)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust ( Site 0721)
state: London, City Of
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
state: Norfolk
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital ( Site 0703)
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.