Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for... | NCT03924856 | Trialant

Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for... | NCT03924856 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Scripps MD Anderson ( Site 0010)

La Jolla, California 92037, United States

Providence Saint John's Health Center ( Site 0075)

Santa Monica, California 90404, United States

Georgetown University Medical Center ( Site 0022)

Washington D.C., District of Columbia 20007, United States

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)

Orlando, Florida 32804, United States

Parkview Cancer Institute ( Site 0077)

Fort Wayne, Indiana 46845, United States

Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)

Indianapolis, Indiana 46202, United States

Ochsner Medical Center ( Site 0049)

New Orleans, Louisiana 70121, United States

New England Cancer Specialists ( Site 0070)

Scarborough, Maine 04074, United States

UMass Memorial Medical Center ( Site 0051)

Worcester, Massachusetts 01655, United States

Henry Ford Hospital ( Site 0039)

Detroit, Michigan 48202, United States

Mercy Hospital Saint Louis ( Site 0064)

St Louis, Missouri 63141, United States

Morristown Medical Center ( Site 0015)

Morristown, New Jersey 07960, United States

UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

Albuquerque, New Mexico 87106, United States

New York University Perlmutter Cancer Center ( Site 0008)

New York, New York 10016, United States

University Hospitals Cleveland Medical Center ( Site 0038)

Cleveland, Ohio 44106, United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

Tulsa, Oklahoma 74146, United States

Portland VA Medical Center ( Site 0084)

Portland, Oregon 97239, United States

Allegheny General Hospital ( Site 0048)

Pittsburgh, Pennsylvania 15212, United States

MD Anderson Cancer Center ( Site 0063)

Houston, Texas 77030, United States

Central Texas Veterans Healthcare System ( Site 0057)

Temple, Texas 76504, United States

Inova Schar Cancer Institute ( Site 0007)

Fairfax, Virginia 22031, United States

Northwest Medical Specialties, PLLC ( Site 0061)

Puyallup, Washington 98373, United States

Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)

Seattle, Washington 98109, United States

Charleston Area Medical Center ( Site 0023)

Charles Town, West Virginia 25304, United States

Mid North Coast Cancer Institute ( Site 1256)

Port Macquarie, New South Wales 2444, Australia

Southside Cancer Care Centre ( Site 1252)

Sydney, New South Wales 2228, Australia

Cairns Base Hospital ( Site 1257)

Cairns, Queensland 4870, Australia

Eastern Health ( Site 1255)

Box Hill, Victoria 3128, Australia

Peninsula Health Frankston Hospital ( Site 1258)

Frankston, Victoria 3199, Australia

UZ Brussel ( Site 0358)

Brussels, Bruxelles-Capitale, Region de 1090, Belgium

Jessa Ziekenhuis ( Site 0360)

Hasselt, Limburg 3500, Belgium

CHU UCL Namur Site de Godinne ( Site 0354)

Yvoir, Namur 5530, Belgium

O.L.V. Ziekenhuis Aalst ( Site 0356)

Aalst, Oost-Vlaanderen 9300, Belgium

AZ Maria Middelares Gent ( Site 0353)

Ghent, Oost-Vlaanderen 9000, Belgium

Tom Baker Cancer Centre ( Site 0100)

Calgary, Alberta T2N 4N2, Canada

Nova Scotia Health Authority ( Site 0109)

Halifax, Nova Scotia B3H 1V7, Canada

Kingston Health Sciences Centre ( Site 0103)

Kingston, Ontario K7L 2V7, Canada

Lakeridge Health ( Site 0104)

Oshawa, Ontario L1G 2B9, Canada

Sunnybrook Research Institute ( Site 0110)

Toronto, Ontario M4N 3M5, Canada

Princess Margaret Cancer Centre ( Site 0107)

Toronto, Ontario M5G 2M9, Canada

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

Montreal, Quebec H1T 2M4, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec G1J 1Z4, Canada

Rigshospitalet University Hospital ( Site 0401)

Copenhagen, Capital Region 2100, Denmark

Herlev og Gentofte Hospital. ( Site 0402)

Herlev, Capital Region 2730, Denmark

Odense Universitetshospital ( Site 0403)

Odense, Region Syddanmark 5000, Denmark

CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

Bordeaux, Aquitaine 33075, France

Centre Leon Berard ( Site 0465)

Lyon, Auvergne 69373, France

Centre Francois Baclesse ( Site 0459)

Caen, Calvados 14075, France

Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)

Plérin, Cotes-d Armor 22190, France

Hopital Foch ( Site 0483)

Suresnes, Hauts-de-Seine 92150, France

CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

Montpellier, Languedoc-Roussillon 34295, France

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)

Angers, Maine-et-Loire 49000, France

Hopital Robert Schuman ( Site 0452)

Metz, Moselle 57070, France

Centre Jean Perrin ( Site 0460)

Clermont-Ferrand, Puy-de-Dome 63011, France

Clinique Victor Hugo ( Site 0463)

Le Mans, Sarthe 72000, France

CHU de Rouen ( Site 0493)

Rouen, Seine-Maritime 76031, France

Institut Sainte Catherine ( Site 0454)

Avignon, Vaucluse 84918, France

Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)

Tübingen, Baden-Wurttemberg 72076, Germany

Universitaetsklinikum Erlangen ( Site 0505)

Erlangen, Bavaria 91058, Germany

Universitaetsklinikum Carl Gustav Carus ( Site 0519)

Dresden, Saxony 01307, Germany

Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)

Magdeburg, Saxony-Anhalt 39120, Germany

Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)

Lübeck, Schleswig-Holstein 23538, Germany

Charite Universitaetsmedizin Berlin ( Site 0515)

Berlin, 10117, Germany

Vivantes Klinikum am Urban ( Site 0522)

Berlin, 10967, Germany

Pecsi Tudomanyegyetem AOK ( Site 1009)

Pécs, Baranya 7624, Hungary

SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

Szeged, Csongrád megye 6720, Hungary

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)

Szolnok, Jász-Nagykun-Szolnok 5004, Hungary

Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

Budapest, 1106, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 1006)

Debrecen, 4032, Hungary

Petz Aladar Megyei Oktato Korhaz ( Site 1012)

Győr, 9023, Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

Kaposvár, 7400, Hungary

Cork University Hospital ( Site 0722)

Cork, T12 DC4A, Ireland

Tallaght University Hospital ( Site 0710)

Dublin, D24 DH74, Ireland

University Hospital Waterford ( Site 0723)

Waterford, X91ER8E, Ireland

Ha Emek Medical Center ( Site 0808)

Afula, 1834111, Israel

Soroka Medical Center ( Site 0806)

Beersheba, 8410101, Israel

Rambam Health Care Campus-Oncology Division ( Site 0802)

Haifa, 3109601, Israel

Shaare Zedek Medical Center ( Site 0809)

Jerusalem, 9103102, Israel

Hadassah Ein Kerem Medical Center ( Site 0810)

Jerusalem, 9112001, Israel

Meir Medical Center ( Site 0803)

Kfar Saba, 4428164, Israel

Rabin Medical Center ( Site 0804)

Petah Tikva, 4941492, Israel

Sheba Medical Center ( Site 0801)

Ramat Gan, 5265601, Israel

Sourasky Medical Center ( Site 0807)

Tel Aviv, 6423906, Israel

Yitzhak Shamir Medical Center ( Site 0805)

Ẕerifin, 7030001, Israel

Policlinico Gemelli di Roma ( Site 0558)

Roma, Abruzzo 00168, Italy

Policlinico di Modena ( Site 0553)

Modena, Emilia-Romagna 41124, Italy

A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

Catania, 95123, Italy

Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

Milan, 20133, Italy

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

Naples, 80131, Italy

Fondazione Salvatore Maugeri IRCCS. ( Site 0554)

Pavia, 27100, Italy

Azienda Ospedaliera San Camillo Forlanini ( Site 0560)

Roma, 00152, Italy

Azienda Ospedaliera Santa Maria Terni ( Site 0557)

Terni, 05100, Italy

Hirosaki University Hospital ( Site 1502)

Hirosaki, Aomori 036-8563, Japan

National Cancer Center Hospital East ( Site 1504)

Kashiwa, Chiba 2778577, Japan

Ehime University Hospital ( Site 1508)

Tōon, Ehime 791-0295, Japan

Sapporo Medical University Hospital ( Site 1501)

Sapporo, Hokkaido 060-8543, Japan

University of Tsukuba Hospital ( Site 1503)

Tsukuba, Ibaraki 305-8576, Japan

Yokosuka Kyosai Hospital ( Site 1509)

Yokosuka, Kanagawa 238-8558, Japan

Nara Medical University Hospital ( Site 1510)

Kashihara, Nara 634-8522, Japan

Saitama Medical University International Medical Center ( Site 1505)

Hidaka, Saitama 350-1298, Japan

Chiba Cancer Center ( Site 1506)

Chiba, 260-8717, Japan

Harasanshin Hospital ( Site 1515)

Fukuoka, 812-0033, Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 1513)

Hiroshima, 730-8518, Japan

Nagano Municipal Hospital ( Site 1516)

Nagano, 381-8551, Japan

Osaka Metropolitan University Hospital ( Site 1512)

Osaka, 545-8586, Japan

Tokushima University Hospital ( Site 1514)

Tokushima, 770-8503, 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 66269, Mexico

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

Aguascalientes, 20010, Mexico

Centro Estatal de Cancerologia de Chihuahua ( Site 0253)

Chihuahua City, 31000, Mexico

Instituto Nacional de Cancerologia ( Site 0256)

Tlalpan, 14080, Mexico

Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)

Wroclaw, Lower Silesian Voivodeship 50-556, Poland

Europejskie Centrum Zdrowia Otwock ( Site 1057)

Otwock, Masovian Voivodeship 05-400, Poland

Luxmed Onkologia sp. z o. o. ( Site 1051)

Warsaw, Masovian Voivodeship 01-748, Poland

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)

Bielsko-Biala, Silesian Voivodeship 43-300, Poland

Clinic of Bashkortostan State Medical University ( Site 0869)

Ufa, Baskortostan, Respublika 450081, Russia

Ivanovo Regional Oncology Dispensary ( Site 0852)

Ivanovo, Ivanovo Oblast 153040, Russia

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

Krasnoyarsk, Krasnoyarsk Krai 660133, Russia

Kursk Regional Clinical Oncology Dispensary ( Site 0854)

Kursk, Kursk Oblast 305524, Russia

FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru

Moscow, Moscow 119285, Russia

Central Clinical Hospital with outpatient Clinic ( Site 0856)

Moscow, Moscow 121359, Russia

Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

Murmansk, Murmansk Oblast 183057, Russia

Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

Nizhny Novgorod, Nizhny Novgorod Oblast 603074, Russia

Omsk Clinical Oncology Dispensary ( Site 0865)

Omsk, Omsk Oblast 644013, Russia

Leningrad Regional Oncology Center ( Site 0868)

Saint Petersburg, Sankt-Peterburg 188663, Russia

Clinical Hospital Saint Luka ( Site 0867)

Saint Petersburg, Sankt-Peterburg 194044, Russia

Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

Saratov, Saratov Oblast 410012, Russia

National Cancer Center ( Site 1354)

Goyang-si, Kyonggi-do 10408, South Korea

Seoul National University Bundang Hospital ( Site 1356)

Seongnam-si, Kyonggi-do 13620, South Korea

Korea University Anam Hospital ( Site 1351)

Seoul, 02841, South Korea

Seoul National University Hospital ( Site 1352)

Seoul, 03080, South Korea

Asan Medical Center ( Site 1355)

Seoul, 05505, South Korea

Samsung Medical Center ( Site 1353)

Seoul, 06351, South Korea

Hospital San Pedro de Alcantara ( Site 0654)

Cáceres, Extremadura 10003, Spain

H. de Gerona Dr. Josep Trueta ( Site 0651)

Girona, Gerona 17007, Spain

Hospital Universitario Ramon y Cajal ( Site 0660)

Madrid, Madrid, Comunidad de 28034, Spain

Hospital Universitario Quiron Madrid ( Site 0657)

Pozuelo de Alarcón, Madrid, Comunidad de 28223, Spain

Instituto Valenciano de Oncologia - IVO ( Site 0662)

Valencia, Valenciana, Comunitat 46009, Spain

Hospital del Mar ( Site 0653)

Barcelona, 08003, Spain

Hospital Universitario San Carlos ( Site 0663)

Madrid, 28040, Spain

Hospital Universitario La Paz ( Site 0661)

Madrid, 28046, Spain

Hospital Nuestra Sra. de Valme ( Site 0658)

Seville, 41014, Spain

Laenssjukhuset Ryhov ( Site 1205)

Jönköping, Jönköping County 551 85, Sweden

Akademiska Sjukhuset ( Site 1201)

Uppsala, Uppsala County 751 85, Sweden

Cancercentrum ( Site 1204)

Umeå, Västerbotten County 901 85, Sweden

Ramathibodi Hospital. ( Site 1451)

Bangkok, Bangkok 10400, Thailand

Faculty of Medicine Siriraj Hospital ( Site 1452)

Bangkok, Bangkok 10700, Thailand

Maharaj Nakorn Chiangmai Hospital ( Site 1453)

Chiang Mai, 50200, Thailand

Srinagarind Hospital ( Site 1454)

Khon Kaen, 40002, Thailand

Hacettepe Universitesi Tıp Fakultesi ( Site 0911)

Ankara, 06100, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)

Istanbul, 34096, Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)

Istanbul, 34722, Turkey (Türkiye)

Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)

Istanbul, 34899, Turkey (Türkiye)

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)

Konya, 42080, Turkey (Türkiye)

Sakarya Universitesi Tip Fakultesi ( Site 0913)

Sakarya, 54290, Turkey (Türkiye)

Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)

Trabzon, 61080, Turkey (Türkiye)

Cherkasy Regional Oncology Dispensary ( Site 0959)

Cherkasy, Cherkasy Oblast 18009, Ukraine

Regional Oncological Hospital ( Site 0956)

Dnipro, Dnipropetrovsk Oblast 49055, Ukraine

Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

Dnipro, Dnipropetrovsk Oblast 49102, Ukraine

MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

Dnipropetrovsk, Dnipropetrovsk Oblast 49005, Ukraine

Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

Kharkiv, Kharkiv Oblast 61037, Ukraine

CNPE "Regional Center of Oncology" ( Site 0958)

Kharkiv, Kharkiv Oblast 61070, Ukraine

National Cancer Institute of the MoH of Ukraine ( Site 0962)

Kyiv, Kyivska Oblast 03022, Ukraine

Lviv Regional Clinical Hospital ( Site 0955)

Lviv, Lviv Oblast 79000, Ukraine

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)

Lviv, Lviv Oblast 79000, Ukraine

Kyiv City Clinical Oncology Center ( Site 0960)

Kyiv, 03115, Ukraine

Aberdeen Royal Infirmary ( Site 0708)

Aberdeen, Aberdeen City AB25 2ZN, United Kingdom

Torbay Hospital ( Site 0704)

Torquay, Devon TQ2 7AA, United Kingdom

Kent and Canterbury Hospital ( Site 0709)

Canterbury, England CT1 3NG, United Kingdom

Lister Hospital ( Site 0715)

Stevenage, Hertfordshire SG1 4AB, United Kingdom

The Royal Marsden Foundation Trust ( Site 0702)

London, London, City of SW3 6JJ, United Kingdom

Imperial College Healthcare NHS Trust ( Site 0721)

London, London, City of W6 8RF, United Kingdom

Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)

Norwich, Norfolk NR4 7UY, United Kingdom

Royal Cornwall Hospital ( Site 0703)

Truro, TR1 3LJ, United Kingdom