Spots Global Cancer Trial Database for A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
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Trial Identification
Brief Title: A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
Official Title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Study ID: NCT03661320
Study Description
Brief Summary: The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 0022, Tucson, Arizona, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Local Institution - 0021, Littleton, Colorado, United States
Local Institution - 0036, Pensacola, Florida, United States
Local Institution - 0004, Tampa, Florida, United States
Local Institution - 0144, Atlanta, Georgia, United States
Local Institution - 0005, Chicago, Illinois, United States
Local Institution - 0006, Peoria, Illinois, United States
Local Institution - 0181, Columbia, Maryland, United States
Local Institution - 0009, Boston, Massachusetts, United States
Local Institution - 0166, Boston, Massachusetts, United States
Local Institution - 0209, Boston, Massachusetts, United States
Local Institution - 0025, Minneapolis, Minnesota, United States
Local Institution - 0129, Minneapolis, Minnesota, United States
Local Institution - 0183, Omaha, Nebraska, United States
Local Institution - 0001, Omaha, Nebraska, United States
Local Institution - 0024, Las Vegas, Nevada, United States
Local Institution - 0029, Albany, New York, United States
Local Institution - 0069, Lake Success, New York, United States
Local Institution - 0047, New York, New York, United States
Local Institution - 0191, Cleveland, Ohio, United States
Local Institution - 0028, Tigard, Oregon, United States
Local Institution - 0189, Charleston, South Carolina, United States
Local Institution - 0007, Nashville, Tennessee, United States
Local Institution - 0030, Austin, Texas, United States
Local Institution - 0023, Norfolk, Virginia, United States
Local Institution - 0051, Capital Federal, Buenos Aires, Argentina
Local Institution - 0049, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0151, Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution - 0131, Garran, Australian Capital Territory, Australia
Local Institution - 0130, Kingswood, New South Wales, Australia
Local Institution - 0157, Macquarie University, New South Wales, Australia
Local Institution - 0043, St Leonards, New South Wales, Australia
Local Institution - 0143, North Adelaide, South Australia, Australia
Local Institution - 0037, Heidelberg, Victoria, Australia
Local Institution - 0038, Murdoch, Western Australia, Australia
Local Institution - 0090, Klagenfurt Am Woerthersee, , Austria
Local Institution - 0091, Krems, , Austria
Local Institution - 0011, Linz, , Austria
Local Institution - 0012, Wien, , Austria
Local Institution - 0060, Bruxelles, , Belgium
Local Institution - 0063, Gent, , Belgium
Local Institution - 0062, Wilrijk, , Belgium
Local Institution - 0094, Fortaleza, Ceara, Brazil
Local Institution - 0099, Ipatinga, Minas Gerais, Brazil
Local Institution - 0092, Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0212, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0097, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0098, Barretos, Sao Paulo, Brazil
Local Institution - 0095, Jau, Sao Paulo, Brazil
Local Institution - 0093, Sao Jose Do Rio Preto, Sao Paulo, Brazil
Local Institution - 0164, Rio De Janeiro, , Brazil
Local Institution - 0214, Sao Paulo, , Brazil
Local Institution - 0159, Kelowna, British Columbia, Canada
Local Institution - 0182, North York, Ontario, Canada
Local Institution - 0192, Chicoutimi, Quebec, Canada
Local Institution - 0190, Montreal, Quebec, Canada
Local Institution - 0053, Santiago, Metropolitana, Chile
Local Institution - 0052, Santiago, Metropolitana, Chile
Local Institution - 0210, Santiago, Metropolitana, Chile
Local Institution - 0054, Santiago, Metropolitana, Chile
Local Institution - 0201, Colombia, Bogota, Colombia
Local Institution - 0104, Bucaramanga, , Colombia
Local Institution - 0103, Monteria, , Colombia
Local Institution - 0148, Helsinki, , Finland
Local Institution - 0145, Tampere, , Finland
Local Institution - 0146, Turku, , Finland
Local Institution - 0202, Brest, Cedex, France
Local Institution - 0204, Créteil, Val-de-Marne, France
Local Institution - 0205, Amiens, , France
Local Institution - 0198, Angers, , France
Local Institution - 0101, Besancon, , France
Local Institution - 0217, Bordeaux, , France
Local Institution - 0199, Clermont-ferrand, , France
Local Institution - 0206, La Tronche, , France
Local Institution - 0075, Marseille, , France
Local Institution - 0200, Montpellier Cedex 5, , France
Local Institution - 0074, Nice, , France
Local Institution - 0163, Paris, , France
Local Institution - 0020, Pierre Benite Cedax, , France
Local Institution - 0188, Saint Herblain Cedex, , France
Local Institution - 0002, Strasbourg Cedex, , France
Local Institution - 0003, TOULOUSE Cedex 9, , France
Local Institution - 0100, Mainz, Rheinland-Pfalz, Germany
Local Institution - 0078, Aachen, , Germany
Local Institution - 0015, Erfurt, , Germany
Local Institution - 0081, Essen, , Germany
Local Institution - 0086, Frankfurt Main, , Germany
Local Institution - 0080, Goettingen, , Germany
Local Institution - 0013, Herne, , Germany
Local Institution - 0010, Jena, , Germany
Local Institution - 0084, Luebeck, , Germany
Local Institution - 0079, Magdeburg, , Germany
Local Institution - 0082, Muenchen, , Germany
Local Institution - 0016, Nuernberg, , Germany
Local Institution - 0085, Trier, , Germany
Local Institution - 0195, Athens, Attikí, Greece
Local Institution - 0031, Larissa, Thessalía, Greece
Local Institution - 0194, Chaidari, , Greece
Local Institution - 0196, Tel Aviv, Tel-Aviv, Israel
Local Institution - 0068, Beer Sheva, , Israel
Local Institution - 0066, Haifa, , Israel
Local Institution - 0067, Ramat Gan, , Israel
Local Institution - 0064, Bari, , Italy
Local Institution - 0193, Forlì, , Italy
Local Institution - 0032, Milano, , Italy
Local Institution - 0065, Modena, , Italy
Local Institution - 0033, Padova, , Italy
Local Institution - 0034, Pisa, , Italy
Local Institution - 0035, Roma, , Italy
Local Institution - 0186, Komaki, Aichi, Japan
Local Institution - 0184, Sapporo, Hokkaido, Japan
Local Institution - 0177, Sapporo, Hokkaido, Japan
Local Institution - 0185, Sapporo, Hokkaido, Japan
Local Institution - 0179, Tsukuba-shi, Ibaraki, Japan
Local Institution - 0171, Kita-gun, Kagawa, Japan
Local Institution - 0169, Yokohama, Kanagawa, Japan
Local Institution - 0168, Niigata-shi, Niigata, Japan
Local Institution - 0173, Osakasayama, Osaka, Japan
Local Institution - 0175, Takatsuki City, Osaka, Japan
Local Institution - 0176, Hidaka-shi, Saitama, Japan
Local Institution - 0170, Hamamatasu, Shizuoka, Japan
Local Institution - 0178, Minato-ku, Tokyo, Japan
Local Institution - 0172, Shinjuku-ku, Tokyo, Japan
Local Institution - 0174, Fukuoka, , Japan
Local Institution - 0180, Kyoto, , Japan
Local Institution - 0137, Goyang-si, Gyeonggi-do, Korea, Republic of
Local Institution - 0203, Seongnam-si, Kyǒnggi-do, Korea, Republic of
Local Institution - 0220, Busan, , Korea, Republic of
Local Institution - 0218, Daegu, , Korea, Republic of
Local Institution - 0208, Gyeongsangnam-do, , Korea, Republic of
Local Institution - 0215, Seongnam-si,, , Korea, Republic of
Local Institution - 0140, Seoul, , Korea, Republic of
Local Institution - 0136, Seoul, , Korea, Republic of
Local Institution - 0211, Seoul, , Korea, Republic of
Local Institution - 0138, Seoul, , Korea, Republic of
Local Institution - 0160, La Paz, BAJA Californa SUR, Mexico
Local Institution - 0102, Zapopan, Jalisco, Mexico
Local Institution - 0056, Monterrey, Nuevo LEON, Mexico
Local Institution - 0105, Colima, , Mexico
Local Institution - 0070, Amsterdam, , Netherlands
Local Institution - 0072, Groningen, , Netherlands
Local Institution - 0073, Sittard-Geleen, , Netherlands
Local Institution - 0087, Auckland, , New Zealand
Local Institution - 0089, Christchurch, , New Zealand
Local Institution - 0158, Gralum, , Norway
Local Institution - 0132, Lorenskog, , Norway
Local Institution - 0133, Oslo, , Norway
Local Institution - 0153, Lisboa, , Portugal
Local Institution - 0152, Porto, , Portugal
Local Institution - 0219, Cluj-Napoca, , Romania
Local Institution - 0076, Craiova, , Romania
Local Institution - 0058, Sector 2, , Romania
Local Institution, Saint-Petersburg, , Russian Federation
Local Institution, St Petersburg, , Russian Federation
Local Institution - 0154, Singapore, , Singapore
Local Institution - 0113, Lugo, , Spain
Local Institution - 0111, Madrid, , Spain
Local Institution - 0112, Madrid, , Spain
Local Institution - 0114, Madrid, , Spain
Local Institution - 0156, Malaga, , Spain
Local Institution - 0109, Sevilla, , Spain
Local Institution - 0135, Kaohsiung, , Taiwan
Local Institution - 0165, Taichung, , Taiwan
Local Institution - 0141, Taipei City, , Taiwan
Local Institution - 0139, Taipei, , Taiwan
Local Institution - 0128, Chelmsford, Essex, United Kingdom
Local Institution - 0127, York, Yorkshire, United Kingdom
Local Institution - 0122, Glasgow, , United Kingdom
Local Institution - 0117, Lancaster, , United Kingdom
Local Institution - 0121, London, , United Kingdom
Local Institution - 0124, Oxford, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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