Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder... | NCT04700124 | Trialant

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder... | NCT04700124 | 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.

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

Has ongoing sensory or motor neuropathy Grade 2 or higher

Has active keratitis (superficial punctate keratitis) or corneal ulcerations

Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms

Mayo Clinic in Arizona - Phoenix ( Site 0043)

Phoenix, Arizona 85054, United States

St Joseph Heritage Healthcare-Oncology ( Site 0035)

Fullerton, California 92835, United States

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005)

Los Angeles, California 90095, United States

University of California San Francisco ( Site 0010)

San Francisco, California 94158, United States

Stanford University ( Site 0023)

Stanford, California 94305, United States

University of Colorado, Anschutz Cancer Pavilion ( Site 0009)

Aurora, Colorado 80045, United States

UF Health ( Site 0031)

Gainesville, Florida 32608, United States

Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)

Indianapolis, Indiana 46202, United States

University of Iowa Hospital and Clinics ( Site 0029)

Iowa City, Iowa 52242, United States

University of Louisville, James Graham Brown Cancer Center ( Site 0022)

Louisville, Kentucky 40202, United States

Icahn School of Medicine at Mount Sinai ( Site 0011)

New York, New York 10029, United States

White Plains Hospital ( Site 0039)

White Plains, New York 10601, United States

Duke University Medical Center ( Site 0017)

Durham, North Carolina 27710, United States

Wake Forest Baptist Health ( Site 0014)

Winston-Salem, North Carolina 27157, United States

Oregon Health and Science University ( Site 0028)

Portland, Oregon 97239-3011, United States

MidLantic Urology ( Site 0002)

Bala-Cynwyd, Pennsylvania 19004, United States

Saint Francis Cancer Center ( Site 0008)

Greenville, South Carolina 29607, United States

The University of Tennessee Medical Center ( Site 0034)

Knoxville, Tennessee 37920, United States

UT Southwestern Medical Center ( Site 0003)

Dallas, Texas 75390, United States

Houston Methodist Urology Associates ( Site 0033)

Houston, Texas 77030, United States

Urology of San Antonio ( Site 0020)

San Antonio, Texas 78229, United States

University of Wisconsin Hospital and Clinics ( Site 0037)

Madison, Wisconsin 53792, United States

Hospital Británico de Buenos Aires-Oncology ( Site 1551)

Ciudad Autónoma de Buenos Aires, Buenos Aires C1280AEB, Argentina

Hospital Italiano de Buenos Aires ( Site 1554)

ABB, Buenos Aires F.D. C1199ABB, Argentina

Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)

Buenos Aires, Buenos Aires F.D. C1419AHN, Argentina

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)

Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina

Fundacion Estudios Clinicos-Oncology ( Site 1557)

Rosario, Santa Fe Province S2000DEJ, Argentina

Centro de Urología (CDU) ( Site 1552)

Buenos Aires, 1120, Argentina

Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)

Macquarie University, New South Wales 2109, Australia

Mater Hospital Brisbane ( Site 1257)

South Brisbane, Queensland 4101, Australia

Lyell McEwin Hospital ( Site 1252)

Elizabeth Vale, South Australia 5112, Australia

Frankston Hospital-Oncology and Haematology ( Site 1258)

Frankston, Victoria 3199, Australia

MHAT "Uni Hospital" OOD ( Site 1154)

Panagyurishte, Pazardzhik 4500, Bulgaria

Complex Oncology Center Plovdiv ( Site 1151)

Plovdiv, 4000, Bulgaria

MHAT Central Onco Hospital OOD ( Site 1158)

Plovdiv, 4000, Bulgaria

MHAT Serdika ( Site 1152)

Sofia, 1632, Bulgaria

BC Cancer - Vancouver Center ( Site 0110)

Vancouver, British Columbia V5Z 4E6, Canada

CancerCare Manitoba ( Site 0108)

Winnipeg, Manitoba R3E 0V9, Canada

Moncton Hospital ( Site 0107)

Moncton, New Brunswick E1C 6Z8, Canada

Ottawa Hospital Research Institute ( Site 0109)

Ottawa, Ontario K1H 8L6, Canada

Département clinique de médecine de laboratoire du CHUM ( Site 0106)

Montreal, Quebec H3T 1E2, Canada

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)

Guangzhou, Guangdong 510060, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)

Guangzhou, Guangdong 510220, China

Hunan Cancer Hospital ( Site 1403)

Changsha, Hunan 410013, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1404)

Nanjing, Jiangsu 210008, China

Nantong Tumor Hospital-Urology ( Site 1405)

Nantong, Jiangsu 226361, China

Fudan University Shanghai Cancer Center-Urology department ( Site 1401)

Shanghai, Shanghai Municipality 200032, China

Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)

Shanghai, Shanghai Municipality 200127, China

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1653)

Medellín, Antioquia 050030, Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)

Bogotá, Bogota D.C. 111321, Colombia

IMAT S.A.S ( Site 1652)

Montería, Departamento de Córdoba 230002, Colombia

Fundacion Cardiovascular de Colombia ( Site 1657)

Piedecuesta, Santander Department 681017, Colombia

Fundación Valle del Lili ( Site 1656)

Cali, Valle del Cauca Department 760032, Colombia

Klinički bolnički centar Sestre milosrdnice ( Site 1703)

Zagreb, City of Zagreb 10000, Croatia

Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)

Zagreb, City of Zagreb 10000, Croatia

Klinički bolnički centar Osijek ( Site 1705)

Osijek, County of Osijek-Baranja 31000, Croatia

Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)

Split, Split-Dalmatia County 21000, Croatia

Fakultni nemocnice u sv. Anny v Brne ( Site 0253)

Brno, South Moravian 656 91, Czechia

Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)

Hradec Králové, 500 05, Czechia

Fakultni Nemocnice Olomouc ( Site 0251)

Olomouc, 77900, Czechia

Fakultni Thomayerova nemocnice ( Site 0252)

Prague, 140 59, Czechia

CHU La Timone ( Site 0456)

Marseille, Bouches-du-Rhone 13005, France

CHU Jean Minjoz ( Site 0453)

Besançon, Doubs 25000, France

C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( Site 0461)

Brest, Finistere 29200, France

Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)

Toulouse, Haute-Garonne 31059, France

CHU Limoges Hopital Dupuytren ( Site 0459)

Limoges, Haute-Vienne 87042, France

CHU GRENOBLE ALPES ( Site 0468)

La Tronche, Isere 38700, France

Centre Hospitalier Regional du Orleans ( Site 0463)

Orléans, Loiret 45067, France

Polyclinique du Bois ( Site 0458)

Lille, Nord 59000, France

Hopital Diaconesses Croix Saint Simon ( Site 0465)

Paris, 75960, France

Gustave Roussy ( Site 0467)

Villejuif, Île-de-France Region 94805, France

Universitaetsklinikum Freiburg ( Site 0512)

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

Universitaetsklinik fuer Urologie ( Site 0501)

Tübingen, Baden-Wurttemberg 72076, Germany

Caritas Krankenhaus St. Josef ( Site 0502)

Regensburg, Bavaria 93053, Germany

Universitaetsklinikum Wuerzburg ( Site 0520)

Würzburg, Bavaria 97080, Germany

Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)

Herne, North Rhine-Westphalia 44625, Germany

Universitaetsklinikum Muenster ( Site 0516)

Münster, North Rhine-Westphalia 48149, Germany

Universitaetsklinikum Carl Gustav Carus ( Site 0509)

Dresden, Saxony 01307, Germany

Krankenhaus Martha Maria Halle-Doelau ( Site 0507)

Halle, Saxony-Anhalt 06120, Germany

Vivantes Klinikum Am Urban ( Site 0519)

Berlin, 10967, Germany

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)

Pátrai, Achaia 26504, Greece

General Hospital of Athens "Alexandra" ( Site 0303)

Athens, Attica 115 28, Greece

Athens Medical Center ( Site 0304)

Athens, Attica 151 25, Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)

Chaïdári, Attica 124 62, Greece

University General Hospital of Larissa ( Site 0302)

Larissa, Thessaly 411 10, Greece

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)

Szeged, Csongrád megye 6720, Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)

Szolnok, Jász-Nagykun-Szolnok 5004, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 1006)

Debrecen, 4032, Hungary

Rambam Health Care Campus-Oncology ( Site 0751)

Haifa, 3109601, Israel

Hadassah Medical Center-Oncology ( Site 0757)

Jerusalem, 9112001, Israel

Meir Medical Center-oncology ( Site 0754)

Kfar Saba, 4428164, Israel

Rabin Medical Center-Oncology ( Site 0752)

Petah Tikva, 4941492, Israel

Sheba Medical Center-ONCOLOGY ( Site 0753)

Ramat Gan, 5265601, Israel

Sourasky Medical Center-Oncology ( Site 0755)

Tel Aviv, 6423906, Israel

Yitzhak Shamir Medical Center-Oncology ( Site 0756)

Ẕerifin, 70300, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)

Milan, Lombardy 20133, Italy

Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)

Pozzuoli, Napoli 80078, Italy

AOU San Luigi Gonzaga di Orbassano ( Site 0595)

Orbassano, Torino 10043, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)

Verona, Veneto 37126, Italy

Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)

Ancona, 60126, Italy

Ospedale Cannizzaro ( Site 0590)

Catania, 95126, Italy

IRCCS Ospedale San Raffaele ( Site 0596)

Milan, 20132, Italy

Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)

Padova, 35128, Italy

Nagoya University Hospital ( Site 1512)

Nagoya, Aichi-ken 466-8560, Japan

Hirosaki University Hospital ( Site 1501)

Hirosaki, Aomori 036-8563, Japan

University of Tsukuba Hospital ( Site 1502)

Tsukuba, Ibaraki 305-8576, Japan

Kanazawa University Hospital ( Site 1509)

Kanazawa, Ishikawa-ken 920-8641, Japan

Kitasato University Hospital ( Site 1506)

Sagamihara, Kanagawa 252-0375, Japan

Yokohama City University Medical Center ( Site 1508)

Yokohama, Kanagawa 232-0024, Japan

Kanagawa Cancer Center ( Site 1507)

Yokohama, Kanagawa 241-8515, Japan

Tohoku University Hospital ( Site 1503)

Sendai, Miyagi 980-8574, Japan

Hamamatsu University Hospital ( Site 1511)

Hamamatsu, Shizuoka 431-3192, Japan

Gifu University Hospital ( Site 1513)

Gifu, 501-1194, Japan

Nagasaki University Hospital ( Site 1517)

Nagasaki, 852-8510, Japan

Okayama University Hospital ( Site 1516)

Okayama, 700-8558, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1514)

Osaka, 541-8567, Japan

Osaka Metropolitan University Hospital ( Site 1515)

Osaka, 545-8586, Japan

Institute of Science Tokyo Hospital ( Site 1505)

Tokyo, 113-8519, Japan

Keio University Hospital ( Site 1504)

Tokyo, 160-8582, Japan

Toyama University Hospital ( Site 1510)

Toyama, 930-0194, Japan

University Malaya Medical Centre ( Site 0352)

Lembah Pantai, Kuala Lumpur 59100, Malaysia

Hospital Pulau Pinang ( Site 0355)

George Town, Pulau Pinang 10450, Malaysia

Sarawak General Hospital ( Site 0351)

Kuching, Sarawak 93586, Malaysia

Sunway Medical Centre ( Site 0353)

Petaling Jaya, Selangor 47500, Malaysia

THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 0801)

Iloilo City, Iloilo 5000, Philippines

Clinical Research Center Medic-R ( Site 1061)

Poznan, Greater Poland Voivodeship 61-731, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)

Siedlce, Masovian Voivodeship 08-110, Poland

Narodowy Instytut Onkologii ( Site 1051)

Warsaw, Masovian Voivodeship 02-781, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)

Przemyśl, Podkarpackie Voivodeship 37-700, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)

Wrocław, Silesian Voivodeship 50556, Poland

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)

Koszalin, West Pomeranian Voivodeship 75-581, Poland

Unidade Local de Saude de Coimbra - Hospitais da Universidade de Coimbra ( Site 0406)

Coimbra, 3000-075, Portugal

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)

Lisbon, 1099-023, Portugal

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0401)

Lisbon, 1449-005, Portugal

Unidade Local de Saude de Santo António - Hospital Santo António ( Site 0408)

Porto, 4099-001, Portugal

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1104)

Bucharest, Bucharest 013823, Romania

Cardiomed SRL Cluj-Napoca ( Site 1101)

Cluj-Napoca, Cluj 400015, Romania

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)

Cluj-Napoca, Cluj 400015, Romania

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)

Cluj-Napoca, Cluj 400015, Romania

SC Radiotherapy Center Cluj SRL ( Site 1108)

Comuna Floresti, Cluj 407280, Romania

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)

Craiova, Dolj 200542, Romania

Policlinica Oncomed SRL ( Site 1106)

Timișoara, Timiș County 300239, Romania

Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)

Cluj-Napoca, 400015, Romania

Altay Regional Oncology Dispensary ( Site 0851)

Barnaul, Altayskiy Kray 656045, Russia

National Medical Research Radiology Centre ( Site 0869)

Obninsk, Kaluzskaja Oblast 249036, Russia

National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)

Moscow, Moscow 115230, Russia

First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)

Moscow, Moscow 119991, Russia

Volga District Medical Center ( Site 0876)

Nizhny Novgorod, Nizhny Novgorod Oblast 603074, Russia

St.Petersburg Clinical Hospital RAS ( Site 0864)

Saint Petersburg, Sankt-Peterburg 194017, Russia

St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)

Saint Petersburg, Sankt-Peterburg 197101, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Sverdlovsk Regional Oncology Hospital ( Site 0867)

Yekaterinburg, Sverdlovsk Oblast 620036, Russia

Sverdlovsky Regional Clinical hospital #1 ( Site 0868)

Yekaterinburg, Sverdlovsk Oblast 620102, Russia

Volgograd Regional Uronephrological Center ( Site 0870)

Volzhsky, Volgograd Oblast 404120, Russia

Tan Tock Seng Hospital ( Site 0704)

Singapore, Central Singapore 308442, Singapore

Wits Clinical Research ( Site 0603)

Johannesburg, Gauteng 2193, South Africa

Steve Biko Academic Hospital ( Site 0601)

Pretoria, Gauteng 0002, South Africa

Groote Schuur Hospital ( Site 0602)

Cape Town, Western Cape 7925, South Africa

Chonnam National University Hwasun Hospital ( Site 1353)

Jeollanam-do, Jeonranamdo 58128, South Korea

Seoul National University Bundang Hospital ( Site 1355)

Gyeonggi-do, Kyonggi-do 13620, South Korea

Asan Medical Center ( Site 1352)

Songpagu, Seoul 05505, South Korea

Kyungpook National University Chilgok Hospital ( Site 1354)

Daegu, Taegu-Kwangyokshi 41404, South Korea

Gachon University Gil Medical Center ( Site 1356)

Incheon, 21565, South Korea

Korea University Anam Hospital ( Site 1357)

Seoul, 02841, South Korea

Seoul National University Hospital ( Site 1351)

Seoul, 03080, South Korea

Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)

Badalona, Barcelona 08916, Spain

Xarxa Assistencial Universitaria Manresa ( Site 0655)

Manresa, Barcelona 08243, Spain

Institut Català d'Oncologia (ICO) - Girona ( Site 0653)

Girona, Gerona 17007, Spain

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)

Santiago de Compostela, La Coruna 15706, Spain

Hospital Universitario Insular de Gran Canaria ( Site 0657)

Las Palmas de Gran Canaria, Las Palmas 35016, Spain

Hospital Universitario Central de Asturias ( Site 0654)

Oviedo, Principality of Asturias 33011, Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)

Valencia, Valenciana, Comunitat 46009, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)

Barcelona, 08035, Spain

Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)

Madrid, 28040, Spain

Hospital Virgen del Rocio ( Site 0659)

Seville, 41013, Spain

Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)

Kaohsiung City, 83301, Taiwan

China Medical University Hospital ( Site 1202)

Taichung, 404332, Taiwan

Taipei Veterans General Hospital ( Site 1201)

Taipei, 112, Taiwan

I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)

Dnipro, Dnipropetrovsk Oblast 49005, Ukraine

MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)

Dnipro, Dnipropetrovsk Oblast 49055, Ukraine

Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)

Kharkiv, Kharkiv Oblast 61037, Ukraine

MNPE Regional Center of Oncology ( Site 0955)

Kharkiv, Kharkiv Oblast 61070, Ukraine

Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)

Kharkiv, Kharkiv Oblast 61166, Ukraine

Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)

Lviv, Lviv Oblast 79031, Ukraine

Zhytomyr Regional Oncology Center ( Site 0961)

Zhytomyr, Zhytomyr Oblast 10002, Ukraine

Torbay Hospital ( Site 1804)

Torquay, Devon TQ2 7AA, United Kingdom

Charing Cross Hospital-Oncology Research ( Site 1802)

London, Hammersmith and Fulham W6 8RF, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)

London, London, City of EC1A 7BE, United Kingdom