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Brief Title: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Official Title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
Study ID: NCT04039607
Brief Summary: The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0292, Tucson, Arizona, United States
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Local Institution - 0037, Caba, Buenos Aires, Argentina
Local Institution - 0194, Pilar Provincia De Buenos Aires, Buenos Aires, Argentina
Local Institution - 0282, Rosario, Santa Fe, Argentina
Local Institution - 0136, Buenos Aires, , Argentina
Local Institution - 0058, Tucuman, , Argentina
Local Institution - 0003, Kogarah, New South Wales, Australia
Local Institution - 0038, Liverpool, New South Wales, Australia
Local Institution - 0002, Westmead, New South Wales, Australia
Local Institution - 0004, Birtinya, Queensland, Australia
Local Institution - 0013, Herston, Queensland, Australia
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Local Institution - 0001, Melbourne, Victoria, Australia
Local Institution - 0020, St Albans, Victoria, Australia
Local Institution - 0114, St. Polten, Niederosterreich, Austria
Local Institution - 0057, Wiener Neustadt, Niederosterreich, Austria
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Local Institution - 0034, Brussels, , Belgium
Local Institution - 0008, Federal District, , Belgium
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Local Institution - 0298, Gent, , Belgium
Local Institution - 0099, Haine-Saint-Paul, , Belgium
Local Institution - 0064, Leuven, , Belgium
Local Institution - 0104, Liege, , Belgium
Local Institution, Salvador, Bahia, Brazil
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Local Institution - 0181, Brasilia, DF, Brazil
Local Institution - 0278, Vitoria, Espirito Santo, Brazil
Local Institution - 0279, Ijui, Rio Grande Do Sul, Brazil
Local Institution - 0060, Pelotas, RIO Grande DO SUL, Brazil
Local Institution - 0054, Jau, SAO Paulo, Brazil
Local Institution - 0280, Sao Jose do Rio Preto, Sao Paulo, Brazil
Local Institution - 0016, Parana, , Brazil
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Local Institution - 0192, Edmonton, Alberta, Canada
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Local Institution, Munchen, , Germany
Local Institution - 0053, North Rhine-Westphalia, , Germany
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Local Institution - 0110, Meldola, Forli-Cesena, Italy
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Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR