A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors
NCT ID: NCT04567615
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
266 participants
INTERVENTIONAL
2021-02-04
2025-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A : Nivolumab
Nivolumab
Specified dose on specified days
Arm B : Nivolumab + Relatlimab Dose 1
Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Arm C : Nivolumab + Relatlimab Dose 2
Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have advanced/metastatic HCC
* Have to be immunotherapy treatment-naive in the advanced/metastatic setting
* Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
* Child-Pugh score of 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale
Exclusion Criteria
* Prior organ allograft or allogeneic bone marrow transplantation
* No uncontrolled or significant cardiovascular disease
* No active known autoimmune disease
* Have received one or two lines of tyrosine kinase inhibitor therapies
* Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0010
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0019
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0017
Rosario, Santa Fe Province, Argentina
Local Institution - 0063
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0025
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0060
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0016
Barretos, São Paulo, Brazil
Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology
Ribeirão Preto, São Paulo, Brazil
Local Institution - 0015
São Paulo, São Paulo, Brazil
Local Institution - 0024
Temuco, Región de la Araucanía, Chile
Local Institution - 0029
Santiago, Santiago Metropolitan, Chile
Local Institution - 0018
Santiago, Santiago Metropolitan, Chile
Local Institution - 0113
Harbin, Heilongjiang, China
Local Institution - 0114
Changsha, Hunan, China
Local Institution - 0118
Xi'an, Shaanxi, China
Local Institution - 0108
Xi'an, Shan3xi, China
Local Institution - 0107
Shanghai, Shanghai Municipality, China
Local Institution - 0117
Hangzhou, Zhejiang, China
Local Institution - 0048
Brno, , Czechia
Local Institution - 0047
Hradec Králové, , Czechia
Local Institution - 0046
Prague, , Czechia
Local Institution - 0069
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Local Institution - 0068
Clichy, , France
Local Institution - 0105
Grenoble, , France
Local Institution - 0074
Lyon, , France
Local Institution - 0067
Pessac, , France
Local Institution - 0077
Hksar, , Hong Kong
Local Institution - 0079
Shatin, , Hong Kong
Local Institution - 0072
Matsuyama, Ehime, Japan
Local Institution - 0054
Yokohama, Kanagawa, Japan
Local Institution - 0076
Yokohama, Kanagawa, Japan
Local Institution - 0045
Ōsaka-sayama, Osaka, Japan
Local Institution - 0075
Ishikawa, , Japan
Local Institution - 0071
Kyoto, , Japan
Local Institution - 0101
San Luis Potosí City, San Luis Potosí, Mexico
Local Institution - 0100
Cuauhtémoc, , Mexico
Local Institution - 0106
Oaxaca City, , Mexico
Local Institution - 0003
Auckland, , New Zealand
Local Institution - 0013
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0012
Bytom, , Poland
Local Institution - 0009
Mysowice, , Poland
Local Institution - 0039
Warsaw, , Poland
Local Institution - 0038
Craiova, Dolj, Romania
Local Institution - 0037
Bucharest, , Romania
Local Institution - 0036
Cluj-Napoca, , Romania
Local Institution - 0070
Suceava, , Romania
Local Institution - 0001
Singapore, Central Singapore, Singapore
Local Institution - 0004
Singapore, , Singapore
Local Institution - 0011
Seoul, Seoul-teukbyeolsi, South Korea
Local Institution - 0020
Seongnam-si, , South Korea
Local Institution - 0043
Seoul, , South Korea
Local Institution - 0050
Donostia / San Sebastian, Gipuzkoa, Spain
Local Institution - 0066
Barcelona, , Spain
Local Institution - 0073
Córdoba, , Spain
Local Institution - 0051
Madrid, , Spain
Local Institution - 0049
Madrid, , Spain
Local Institution - 0058
Pamplona, , Spain
Local Institution - 0041
Taichung, , Taiwan
Local Institution - 0034
Tainan, , Taiwan
Local Institution - 0031
Taipei, , Taiwan
Local Institution - 0042
Taipei, , Taiwan
Local Institution - 0032
Taoyuan District, , Taiwan
Local Institution - 0089
Ankara, , Turkey (Türkiye)
Local Institution - 0090
Edirne, , Turkey (Türkiye)
Local Institution - 0091
Kadiköy/Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-003151-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1218-6499
Identifier Type: OTHER
Identifier Source: secondary_id
CA224-073
Identifier Type: -
Identifier Source: org_study_id
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