Bladder Cancer Clinical Trial
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)
Summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
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.
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There are 173 Locations for this study
La Jolla California, 92037, United States
Santa Monica California, 90404, United States
Washington District of Columbia, 20007, United States
Orlando Florida, 32804, United States
Fort Wayne Indiana, 46845, United States
Indianapolis Indiana, 46202, United States
New Orleans Louisiana, 70121, United States
Scarborough Maine, 04074, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63141, United States
Morristown New Jersey, 07960, United States
Albuquerque New Mexico, 87106, United States
New York New York, 10016, United States
Cleveland Ohio, 44106, United States
Tulsa Oklahoma, 74146, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15212, United States
Houston Texas, 77030, United States
Temple Texas, 76504, United States
Fairfax Virginia, 22031, United States
Puyallup Washington, 98373, United States
Seattle Washington, 98109, United States
Charles Town West Virginia, 25304, United States
Port Macquarie New South Wales, 2444, Australia
Sydney New South Wales, 2228, Australia
Cairns Queensland, 4870, Australia
Box Hill Victoria, 3128, Australia
Frankston Victoria, 3199, Australia
Brussels Bruxelles-Capitale, Region De, 1090, Belgium
Hasselt Limburg, 3500, Belgium
Yvoir Namur, 5530, Belgium
Aalst Oost-Vlaanderen, 9300, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Calgary Alberta, T2N 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Kingston Ontario, K7L 2, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Quebec City Quebec, G1J 1, Canada
Herlev Hovedstaden, 2730, Denmark
Kobenhavn Hovedstaden, 2100, Denmark
Odense Syddanmark, 5000, Denmark
Bordeaux Aquitaine, 33075, France
Lyon Auvergne, 69373, France
Caen Calvados, 14075, France
Plerin Cotes-d Armor, 22190, France
Suresnes Hauts-de-Seine, 92150, France
Montpellier Languedoc-Roussillon, 34295, France
Angers Maine-et-Loire, 49000, France
Metz Moselle, 57070, France
Clermont-Ferrand Puy-de-Dome, 63011, France
Le Mans Sarthe, 72000, France
Rouen Seine-Maritime, 76031, France
Avignon Vaucluse, 84918, France
Tuebingen Baden-Wurttemberg, 72076, Germany
Erlangen Bayern, 91058, Germany
Magdeburg Sachsen-Anhalt, 39120, Germany
Dresden Sachsen, 01307, Germany
Luebeck Schleswig-Holstein, 23538, Germany
Berlin , 10117, Germany
Berlin , 10967, Germany
Pecs Baranya, 7624, Hungary
Szeged Csongrad, 6720, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary
Budapest , 1106, Hungary
Debrecen , 4032, Hungary
Gyor , 9023, Hungary
Kaposvar , 7400, Hungary
Cork , T12 D, Ireland
Dublin , D24 D, Ireland
Waterford , X91ER, Ireland
Afula , 18341, Israel
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petach Tikva , 49414, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Zerifin , 70300, Israel
Roma Abruzzo, 00168, Italy
Modena Emilia-Romagna, 41124, Italy
Catania , 95123, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Pavia , 27100, Italy
Roma , 00152, Italy
Terni , 05100, Italy
Hirosaki Aomori, 036-8, Japan
Kashiwa Chiba, 27785, Japan
Toon Ehime, 791-0, Japan
Sapporo Hokkaido, 060-8, Japan
Tsukuba Ibaraki, 305-8, Japan
Yokosuka Kanagawa, 238-8, Japan
Kashihara Nara, 634-8, Japan
Hidaka Saitama, 350-1, Japan
Chiba , 260-8, Japan
Fukuoka , 812-0, Japan
Hiroshima , 730-8, Japan
Nagano , 381-8, Japan
Osaka , 545-8, Japan
Tokushima , 770-8, Japan
Tokyo , , Japan
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Monterrey Nuevo Leon, 66269, Mexico
Aguascalientes , 20010, Mexico
Chihuahua , 31000, Mexico
Tlalpan , 14080, Mexico
Wroclaw Dolnoslaskie, 50-55, Poland
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Otwock Mazowieckie, 05-40, Poland
Warszawa Mazowieckie, 01-74, Poland
Bielsko-Biala Slaskie, 43-30, Poland
Ufa Baskortostan, Respublika, 45008, Russian Federation
Ivanovo Ivanovskaya Oblast, 15304, Russian Federation
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Kursk Kurskaya Oblast, 30552, Russian Federation
Moscow Moskva, 11928, Russian Federation
Moscow Moskva, 12135, Russian Federation
Murmansk Murmanskaya Oblast, 18305, Russian Federation
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Omsk Omskaya Oblast, 64401, Russian Federation
Saint Petersburg Sankt-Peterburg, 18866, Russian Federation
St. Petersburg Sankt-Peterburg, 19404, Russian Federation
Saratov Saratovskaya Oblast, 41001, Russian Federation
Caceres Extremadura, 10003, Spain
Girona Gerona, 17007, Spain
Madrid Madrid, Comunidad De, 28034, Spain
Pozuelo de Alarcon Madrid, Comunidad De, 28223, Spain
Valencia Valenciana, Comunitat, 46009, Spain
Barcelona , 08003, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Sevilla , 41014, Spain
Jonkoping Jonkopings Lan, 551 8, Sweden
Uppsala Uppsala Lan, 751 8, Sweden
Umea Vasterbottens Lan, 901 8, Sweden
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Chiang Mai , 50200, Thailand
Khon Kaen , 40002, Thailand
Ankara , 06100, Turkey
Istanbul , 34096, Turkey
Istanbul , 34722, Turkey
Istanbul , 34899, Turkey
Konya , 42080, Turkey
Sakarya , 54290, Turkey
Trabzon , 61080, Turkey
Cherkasy Cherkaska Oblast, 18009, Ukraine
Dnipropetrovsk Dnipropetrovska Oblast, 49005, Ukraine
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Kharkiv Kharkivska Oblast, 61037, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kyiv Kyivska Oblast, 03022, Ukraine
Lviv Lvivska Oblast, 79000, Ukraine
Lviv Lvivska Oblast, 79000, Ukraine
Kyiv , 03115, Ukraine
Aberdeen Aberdeen City, AB25 , United Kingdom
Torquay Devon, TQ2 7, United Kingdom
Canterbury England, CT1 3, United Kingdom
Stevenage Hertfordshire, SG1 4, United Kingdom
London London, City Of, SW3 6, United Kingdom
London London, City Of, W6 8R, United Kingdom
Norwich Norfolk, NR4 7, United Kingdom
Truro , TR1 3, United Kingdom
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