Spots Global Cancer Trial Database for A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
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Trial Identification
Brief Title: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
Official Title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
Study ID: NCT04810078
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution, Chicago, Illinois, United States
Local Institution - 0025, Buffalo, New York, United States
Local Institution - 0088, West Reading, Pennsylvania, United States
Local Institution - 0038, Ciudad Autonoma de BuenosAires, Buenos Aires, Argentina
Local Institution - 0058, Mar Del Plata, Buenos Aires, Argentina
Local Institution - 0037, Pergamino, Buenos Aires, Argentina
Local Institution - 0079, Parana, Cordoba, Argentina
Cent Priv RMI Rio Cuarto SA II, Rio Cuarto, Cordoba, Argentina
Local Institution - 0066, Viedma, RIO Negro, Argentina
Local Institution - 0056, San Juan, , Argentina
Local Institution - 0064, Curitiba, Parana, Brazil
Local Institution - 0011, Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0107, Ijui, Rio Grande Do Sul, Brazil
Local Institution - 0039, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0071, Barretos, Sao Paulo, Brazil
Local Institution - 0070, Sao Jose Do Rio Preto, Sao Paulo, Brazil
Local Institution - 0090, Rio de Janeiro, , Brazil
Local Institution - 0095, Sao Paulo, , Brazil
Local Institution - 0081, Sao Paulo, , Brazil
Local Institution - 0096, Sao Paulo, , Brazil
Local Institution - 0084, Temuco, Araucania, Chile
Local Institution - 0005, Santiago de Chile, Metropolitana, Chile
Local Institution - 0104, Santiago de Chile, Metropolitana, Chile
Local Institution - 0076, Santiago, Metropolitana, Chile
Local Institution - 0077, Vina del Mar, Valparaiso, Chile
Local Institution - 0063, Brno, , Czechia
Local Institution - 0036, Hradec Kralove, , Czechia
Local Institution - 0020, Olomouc, , Czechia
Local Institution - 0099, Ostrava, , Czechia
Local Institution - 0010, Prague, , Czechia
Local Institution - 0106, Praha 8 Liben, , Czechia
Local Institution, Jyvaskyla, , Finland
Local Institution - 0080, Kuopio, , Finland
Local Institution - 0017, Tampere, , Finland
Local Institution - 0047, Turku, , Finland
Local Institution - 0073, Lyon, , France
Local Institution, Nice cedex 2, , France
Local Institution - 0051, Suresnes, , France
Local Institution, Toulouse, , France
Local Institution - 0068, Villejuif, , France
Local Institution - 0060, Tallaght, Dublin, Ireland
Local Institution, Cork, , Ireland
Local Institution, Dublin, , Ireland
Local Institution - 0033, Cremona, , Italy
Local Institution - 0008, Firenze, , Italy
Local Institution - 0027, Meldola, , Italy
Local Institution, Milano, , Italy
Local Institution - 0018, Milan, , Italy
Local Institution - 0014, Padova, , Italy
Local Institution - 0082, Parma, , Italy
Local Institution - 0092, Pavia, , Italy
Local Institution, Pisa, , Italy
Local Institution - 0100, Roma, , Italy
Local Institution - 0091, Rome, , Italy
Local Institution - 0057, Terni, , Italy
Local Institution - 0101, Torreon, Coahuila, Mexico
Local Institution - 0089, Tlalpan, Distrito Federal, Mexico
Local Institution - 0103, Monterrey, Nuevo LEON, Mexico
Local Institution - 0031, Monterrey, Nuevo LEON, Mexico
Local Institution - 0065, Queretaro, , Mexico
Local Institution - 0085, Queretaro, , Mexico
Local Institution - 0105, San Luis Potosi, , Mexico
Auckland District Health Board-Auckland City Hospital, Auckland, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Palmerston North Hospital, Palmerston North, , New Zealand
Local Institution - 0055, Biala Podlaska, , Poland
Local Institution - 0062, Bydgoszcz, , Poland
Local Institution - 0083, Gdansk, , Poland
Local Institution - 0009, Gliwice, , Poland
Local Institution - 0021, Krakow, , Poland
Local Institution - 0098, Krakow, , Poland
Local Institution - 0001, Poznan, , Poland
Local Institution - 0023, Warszawa, , Poland
Local Institution - 0050, Coimbra, , Portugal
Local Institution - 0052, Lisboa, , Portugal
Local Institution - 0024, Bucuresti, , Romania
Local Institution - 0002, Cluj-Napoca, , Romania
Local Institution - 0040, Cluj-Napoca, , Romania
Local Institution - 0016, Craiova, , Romania
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine, Chelyabinsk, , Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Local Institution, Moscow, , Russian Federation
Local Institution, Moscow, , Russian Federation
Local Institution - 0015, Moscow, , Russian Federation
Local Institution, Moscow, , Russian Federation
Hertzen Moscow Oncology Research Center, Moscow, , Russian Federation
Local Institution, Nizghiy Novgorod, , Russian Federation
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary, Omsk, , Russian Federation
LLC Eurocityclinic, Saint Petersburg, , Russian Federation
Local Institution - 0048, Barcelona, , Spain
Local Institution - 0102, Barcelona, , Spain
Local Institution - 0049, Barcelona, , Spain
Local Institution - 0072, Madrid, , Spain
Local Institution - 0067, Madrid, , Spain
Local Institution - 0074, Madrid, , Spain
Local Institution - 0075, Madrid, , Spain
Local Institution - 0032, Sabadell, , Spain
Local Institution - 0086, Santander, , Spain
Local Institution - 0059, Sevilla, , Spain
Local Institution, Adana, , Turkey
Local Institution - 0026, Ankara, , Turkey
Local Institution - 0097, Ankara, , Turkey
Local Institution - 0019, Istanbul, , Turkey
Local Institution - 0035, Istanbul, , Turkey
Local Institution, Izmir, , Turkey
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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