Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: Merck Sharp & Dohme LLC
Summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
907
Start Date
2019-06-13
Completion Date
2026-09-01
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Gemcitabine
Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
Cisplatin
Cisplatin 70 mg/m\^2, IV infusion 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.
Placebo
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
Locations (175)
Scripps MD Anderson ( Site 0010)
La Jolla, California, United States
Providence Saint John's Health Center ( Site 0075)
Santa Monica, California, United States
Georgetown University Medical Center ( Site 0022)
Washington D.C., District of Columbia, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
Orlando, Florida, United States
Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
Indianapolis, Indiana, United States
Ochsner Medical Center ( Site 0049)
New Orleans, Louisiana, United States
New England Cancer Specialists ( Site 0070)
Scarborough, Maine, United States
UMass Memorial Medical Center ( Site 0051)
Worcester, Massachusetts, United States
Henry Ford Hospital ( Site 0039)
Detroit, Michigan, United States
Mercy Hospital Saint Louis ( Site 0064)
St Louis, Missouri, 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
New York University Perlmutter Cancer Center ( Site 0008)
New York, New York, United States
University Hospitals Cleveland Medical Center ( Site 0038)
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma, United States
Portland VA Medical Center ( Site 0084)
Portland, Oregon, United States
Allegheny General Hospital ( Site 0048)
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center ( Site 0063)
Houston, Texas, United States
Central Texas Veterans Healthcare System ( Site 0057)
Temple, Texas, United States
Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 0061)
Puyallup, Washington, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
Seattle, Washington, United States
Charleston Area Medical Center ( Site 0023)
Charles Town, West Virginia, United States
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie, New South Wales, Australia
Southside Cancer Care Centre ( Site 1252)
Sydney, New South Wales, Australia
Cairns Base Hospital ( Site 1257)
Cairns, Queensland, Australia
Eastern Health ( Site 1255)
Box Hill, Victoria, Australia
Peninsula Health Frankston Hospital ( Site 1258)
Frankston, Victoria, Australia
UZ Brussel ( Site 0358)
Brussels, Bruxelles-Capitale, Region de, Belgium
Jessa Ziekenhuis ( Site 0360)
Hasselt, Limburg, Belgium
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir, Namur, Belgium
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst, Oost-Vlaanderen, Belgium
AZ Maria Middelares Gent ( Site 0353)
Ghent, Oost-Vlaanderen, Belgium
Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta, Canada
Nova Scotia Health Authority ( Site 0109)
Halifax, Nova Scotia, Canada
Kingston Health Sciences Centre ( Site 0103)
Kingston, Ontario, Canada
Lakeridge Health ( Site 0104)
Oshawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
Rigshospitalet University Hospital ( Site 0401)
Copenhagen, Capital Region, Denmark
Herlev og Gentofte Hospital. ( Site 0402)
Herlev, Capital Region, Denmark
Odense Universitetshospital ( Site 0403)
Odense, Region Syddanmark, Denmark
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux, Aquitaine, France
Centre Leon Berard ( Site 0465)
Lyon, Auvergne, France
Centre Francois Baclesse ( Site 0459)
Caen, Calvados, France
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
Plérin, Cotes-d Armor, France
Hopital Foch ( Site 0483)
Suresnes, Hauts-de-Seine, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Languedoc-Roussillon, France
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
Angers, Maine-et-Loire, France
Hopital Robert Schuman ( Site 0452)
Metz, Moselle, France
Centre Jean Perrin ( Site 0460)
Clermont-Ferrand, Puy-de-Dome, France
Clinique Victor Hugo ( Site 0463)
Le Mans, Sarthe, France
CHU de Rouen ( Site 0493)
Rouen, Seine-Maritime, France
Institut Sainte Catherine ( Site 0454)
Avignon, Vaucluse, France
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 0505)
Erlangen, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden, Saxony, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
Magdeburg, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
Lübeck, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin ( Site 0515)
Berlin, Germany
Vivantes Klinikum am Urban ( Site 0522)
Berlin, Germany
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pécs, Baranya, Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Csongrád megye, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
Szolnok, Jász-Nagykun-Szolnok, 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
Cork University Hospital ( Site 0722)
Cork, Ireland
Tallaght University Hospital ( Site 0710)
Dublin, Ireland
University Hospital Waterford ( Site 0723)
Waterford, Ireland
Ha Emek Medical Center ( Site 0808)
Afula, Israel
Soroka Medical Center ( Site 0806)
Beersheba, Israel
Rambam Health Care Campus-Oncology Division ( Site 0802)
Haifa, Israel
Shaare Zedek Medical Center ( Site 0809)
Jerusalem, Israel
Hadassah Ein Kerem Medical Center ( Site 0810)
Jerusalem, Israel
Meir Medical Center ( Site 0803)
Kfar Saba, Israel
Rabin Medical Center ( Site 0804)
Petah Tikva, Israel
Sheba Medical Center ( Site 0801)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0807)
Tel Aviv, Israel
Yitzhak Shamir Medical Center ( Site 0805)
Ẕerifin, Israel
Policlinico Gemelli di Roma ( Site 0558)
Roma, Abruzzo, Italy
Policlinico di Modena ( Site 0553)
Modena, Emilia-Romagna, Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milan, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Naples, Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
Roma, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
Terni, Italy
Hirosaki University Hospital ( Site 1502)
Hirosaki, Aomori, Japan
National Cancer Center Hospital East ( Site 1504)
Kashiwa, Chiba, Japan
Ehime University Hospital ( Site 1508)
Tōon, Ehime, Japan
Sapporo Medical University Hospital ( Site 1501)
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital ( Site 1503)
Tsukuba, Ibaraki, Japan
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka, Kanagawa, Japan
Nara Medical University Hospital ( Site 1510)
Kashihara, Nara, Japan
Saitama Medical University International Medical Center ( Site 1505)
Hidaka, Saitama, Japan
Chiba Cancer Center ( Site 1506)
Chiba, Japan
Harasanshin Hospital ( Site 1515)
Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
Hiroshima, Japan
Nagano Municipal Hospital ( Site 1516)
Nagano, Japan
Osaka Metropolitan University Hospital ( Site 1512)
Osaka, Japan
Tokushima University Hospital ( Site 1514)
Tokushima, Japan
Tokyo Medical and Dental University Hospital ( Site 1517)
Tokyo, Japan
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
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 0253)
Chihuahua City, Mexico
Instituto Nacional de Cancerologia ( Site 0256)
Tlalpan, Mexico
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw, Lower Silesian Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock, Masovian Voivodeship, Poland
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warsaw, Masovian Voivodeship, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala, Silesian Voivodeship, Poland
Clinic of Bashkortostan State Medical University ( Site 0869)
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
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
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
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov, Saratov Oblast, Russia
National Cancer Center ( Site 1354)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Kyonggi-do, South Korea
Korea University Anam Hospital ( Site 1351)
Seoul, South Korea
Seoul National University Hospital ( Site 1352)
Seoul, South Korea
Asan Medical Center ( Site 1355)
Seoul, South Korea
Samsung Medical Center ( Site 1353)
Seoul, South Korea
Hospital San Pedro de Alcantara ( Site 0654)
Cáceres, Extremadura, Spain
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona, Gerona, Spain
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcón, Madrid, Comunidad de, Spain
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia, Valenciana, Comunitat, Spain
Hospital del Mar ( Site 0653)
Barcelona, Spain
Hospital Universitario San Carlos ( Site 0663)
Madrid, Spain
Hospital Universitario La Paz ( Site 0661)
Madrid, Spain
Hospital Nuestra Sra. de Valme ( Site 0658)
Seville, Spain
Laenssjukhuset Ryhov ( Site 1205)
Jönköping, Jönköping County, Sweden
Akademiska Sjukhuset ( Site 1201)
Uppsala, Uppsala County, Sweden
Cancercentrum ( Site 1204)
Umeå, Västerbotten 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 0911)
Ankara, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
Istanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
Istanbul, Turkey (Türkiye)
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
Istanbul, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
Konya, Turkey (Türkiye)
Sakarya Universitesi Tip Fakultesi ( Site 0913)
Sakarya, Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
Trabzon, Turkey (Türkiye)
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy, Cherkasy Oblast, Ukraine
Regional Oncological Hospital ( Site 0956)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro, Dnipropetrovsk Oblast, Ukraine
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
CNPE "Regional Center of Oncology" ( Site 0958)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv, Kyivska Oblast, Ukraine
Lviv Regional Clinical Hospital ( Site 0955)
Lviv, Lviv Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
Lviv, Lviv Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv, Ukraine
Aberdeen Royal Infirmary ( Site 0708)
Aberdeen, Aberdeen City, United Kingdom
Torbay Hospital ( Site 0704)
Torquay, Devon, United Kingdom
Kent and Canterbury Hospital ( Site 0709)
Canterbury, England, United Kingdom
Lister Hospital ( Site 0715)
Stevenage, Hertfordshire, United Kingdom
The Royal Marsden Foundation Trust ( Site 0702)
London, London, City of, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0721)
London, London, City of, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
Norwich, Norfolk, United Kingdom
Royal Cornwall Hospital ( Site 0703)
Truro, United Kingdom