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ACTIVE NOT RECRUITING
NCT03924856
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle

DRUG

Cisplatin

Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle

PROCEDURE

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.

DRUG

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