Bladder Cancer Clinical Trial
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Summary
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
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
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There are 181 Locations for this study
Phoenix Arizona, 85054, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
San Francisco California, 94158, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Gainesville Florida, 32608, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40202, United States
New York New York, 10029, United States
White Plains New York, 10601, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Portland Oregon, 97239, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Greenville South Carolina, 29607, United States
Knoxville Tennessee, 37920, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Madison Wisconsin, 53792, United States
Ciudad autónoma de Buenos Aires Buenos Aires, 1280, Argentina
ABB Caba, C1199, Argentina
Buenos Aires Caba, C1431, Argentina
Rosario Santa Fe, 2000, Argentina
Buenos Aires , 1120, Argentina
Buenos Aires , C1419, Argentina
Macquarie University New South Wales, 2109, Australia
South Brisbane Queensland, 4101, Australia
Elizabeth Vale South Australia, 5112, Australia
Frankston Victoria, 3199, Australia
Panagyurishte Pazardzhik, 4500, Bulgaria
Plovdiv , 4000, Bulgaria
Plovdiv , 4000, Bulgaria
Sofia , 1632, Bulgaria
Vancouver British Columbia, V5Z 4, Canada
Winnipeg Manitoba, R3E 0, Canada
Moncton New Brunswick, E1C 6, Canada
Ottawa Ontario, K1H 8, Canada
Montreal Quebec, H3T 1, Canada
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51012, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nantong Jiangsu, 22636, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20012, China
Medellin Antioquia, 05003, Colombia
Montería Cordoba, 23000, Colombia
Bogota Distrito Capital De Bogota, 11132, Colombia
Piedecuesta Santander, 68101, Colombia
Cali Valle Del Cauca, 76003, Colombia
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Osijek Osjecko-baranjska Zupanija, 31000, Croatia
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Brno Jihomoravsky Kraj, 656 9, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Praha 4 , 140 5, Czechia
Marseille Bouches-du-Rhone, 13005, France
Besancon Doubs, 25000, France
Brest Finistere, 29200, France
Toulouse Haute-Garonne, 31059, France
Limoges Haute-Vienne, 87042, France
Villejuif Ile-de-France, 94800, France
La Tronche Isere, 38700, France
Orleans Loiret, 45067, France
Lille Nord, 59000, France
Paris , 75020, France
Freiburg Baden-Wurttemberg, 79106, Germany
Tuebingen Baden-Wurttemberg, 72076, Germany
Regensburg Bayern, 93053, Germany
Wuerzburg Bayern, 97080, Germany
Herne Nordrhein-Westfalen, 44625, Germany
Muenster Nordrhein-Westfalen, 48149, Germany
Halle Sachsen-Anhalt, 06120, Germany
Dresden Sachsen, 01307, Germany
Berlin , 10967, Germany
Patras Achaia, 26504, Greece
Athens Attiki, 115 2, Greece
Athens Attiki, 151 2, Greece
Chaidari Attiki, 124 6, Greece
Larissa Thessalia, 411 1, Greece
Szeged Csongrad, 6720, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Debrecen , 4032, Hungary
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petah-Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Zerifin , 70300, Israel
Milan Lombardia, 20133, Italy
Pozzuoli Napoli, 80078, Italy
Orbassano Torino, 10043, Italy
Verona Veneto, 37126, Italy
Ancona , 60126, Italy
Catania , 95126, Italy
Milano , 20132, Italy
Padova , 35128, Italy
Nagoya Aichi, 466-8, Japan
Hirosaki Aomori, 036-8, Japan
Tsukuba Ibaraki, 305-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Sagamihara Kanagawa, 252-0, Japan
Yokohama Kanagawa, 232-0, Japan
Yokohama Kanagawa, 241-8, Japan
Sendai Miyagi, 980-8, Japan
Hamamatsu Shizuoka, 431-3, Japan
Gifu , 501-1, Japan
Nagasaki , 852-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Osaka , 545-8, Japan
Tokyo , 113-8, Japan
Tokyo , 160-8, Japan
Toyama , 930-0, Japan
Jeollanam-do Jeonranamdo, 58128, Korea, Republic of
Gyeonggi-do Kyonggi-do, 13620, Korea, Republic of
Songpagu Seoul, 05505, Korea, Republic of
Daegu Taegu-Kwangyokshi, 41404, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Lembah Pantai Kuala Lumpur, 59100, Malaysia
George Town Pulau Pinang, 10990, Malaysia
Kuching Sarawak, 93586, Malaysia
Petaling Jaya Selangor, 47500, Malaysia
Iloilo City Iloilo, 5000, Philippines
Wrocław Dolnoslaskie, 50-55, Poland
Siedlce Mazowieckie, 08-11, Poland
Warszawa Mazowieckie, 02-78, Poland
Przemysl Podkarpackie, 37-70, Poland
Poznan Wielkopolskie, 61-73, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Coimbra , 3000-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1449-, Portugal
Porto , 4099-, Portugal
Cluj Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40001, Romania
Comuna Floresti Cluj, 40728, Romania
Craiova Dolj, 20054, Romania
Timisoara Timis, 30023, Romania
Bucuresti , 02254, Romania
Cluj , 40001, Romania
Barnaul Altayskiy Kray, 65604, Russian Federation
Obninsk Kaluzskaja Oblast, 24903, Russian Federation
Moscow Moskva, 11523, Russian Federation
Moscow Moskva, 11999, Russian Federation
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Saint Petersburg Sankt-Peterburg, 19401, Russian Federation
Saint Petersburg Sankt-Peterburg, 19710, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Ekaterinburg Sverdlovskaya Oblast, 62003, Russian Federation
Ekaterinburg Sverdlovskaya Oblast, 62010, Russian Federation
Volzhsky Volgogradskaya Oblast, 40412, Russian Federation
Singapore Central Singapore, 30844, Singapore
Johannesburg Gauteng, 2193, South Africa
Pretoria Gauteng, 0002, South Africa
Cape Town Western Cape, 7925, South Africa
Oviedo Asturias, 33011, Spain
Badalona Barcelona, 08916, Spain
Manresa Barcelona, 08243, Spain
Girona Gerona, 17007, Spain
Santiago de Compostela La Coruna, 15706, Spain
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
Valencia Valenciana, Comunitat, 46009, Spain
Barcelona , 08035, Spain
Madrid , 28040, Spain
Sevilla , 41013, Spain
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
Taichung , 40433, Taiwan
Taipei , 11217, Taiwan
Dnipro Dnipropetrovska Oblast, 49005, Ukraine
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Kharkiv Kharkivska Oblast, 61037, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kharkiv Kharkivska Oblast, 61166, Ukraine
Lviv Lvivska Oblast, 79031, Ukraine
Zhytomyr Zhytomyrska Oblast, 10002, Ukraine
Torquay Devon, TQ2 7, United Kingdom
London London, City Of, EC1A , United Kingdom
London London, City Of, W2 1N, United Kingdom
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