A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
NCT ID: NCT05337137
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
83 participants
INTERVENTIONAL
2022-05-05
2025-11-18
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
TRIPLE
Study Groups
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Arm A: Relatlimab + Nivolumab + Bevacizumab
Relatlimab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Arm B: Placebo + Nivolumab + Bevacizumab
Nivolumab
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Relatlimab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
* Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
* Prior allogenic stem cell or solid organ transplantation
* Untreated symptomatic central nervous system (CNS) metastases
* Clinically significant ascites as defined by:
i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment
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 - 0042
Los Angeles, California, United States
Local Institution - 0039
Los Angeles, California, United States
Local Institution - 0034
San Francisco, California, United States
Local Institution - 0030
Washington D.C., District of Columbia, United States
Local Institution - 0059
Baltimore, Maryland, United States
Local Institution - 0060
Boston, Massachusetts, United States
Local Institution - 0065
Boston, Massachusetts, United States
Local Institution - 0061
New York, New York, United States
Local Institution - 0062
The Bronx, New York, United States
Local Institution - 0033
Milwaukee, Wisconsin, United States
Local Institution - 0045
Camperdown, New South Wales, Australia
Local Institution - 0022
Adelaide, South Australia, Australia
Local Institution - 0026
Heidelberg, Victoria, Australia
Local Institution - 0013
Melbourne, Victoria, Australia
Local Institution - 0017
Nedlands, Western Australia, Australia
Local Institution - 0025
Edmonton, Alberta, Canada
Local Institution - 0009
Toronto, Ontario, Canada
Local Institution - 0064
Guangzhou, Guangdong, China
Local Institution - 0066
Xi'an, Shan3xi, China
Local Institution - 0021
Avignon, Cedex 9, France
Local Institution - 0012
Grenoble, , France
Local Institution - 0001
Nice, , France
Local Institution - 0002
Reims, , France
Local Institution - 0008
Rennes, , France
Local Institution - 0054
Suresnes, , France
Local Institution - 0051
Düsseldorf, North Rhine-Westphalia, Germany
Local Institution - 0035
Frankfurt, , Germany
Local Institution - 0057
Mainz, , Germany
Local Institution - 0055
Munich, , Germany
Local Institution - 0004
Hong Kong, , Hong Kong
Local Institution - 0031
Shatin, , Hong Kong
Local Institution - 0036
Milan, , Italy
Local Institution - 0003
Padua, , Italy
Local Institution - 0010
Roma, , Italy
Local Institution - 0047
Kashiwa-shi, Chiba, Japan
Local Institution - 0048
Matsuyama, Ehime, Japan
Local Institution - 0058
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0050
Yokohama, Kanagawa, Japan
Local Institution - 0041
Sayama, Osaka, Japan
Local Institution - 0063
Chuo-ku, Tokyo, Japan
Local Institution - 0028
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0016
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0023
Gdansk, , Poland
Local Institution - 0052
Rio Piedras, PR, Puerto Rico
Local Institution - 0019
San Juan, , Puerto Rico
Local Institution - 0029
Singapore, , Singapore
Local Institution - 0027
Singapore, , Singapore
Local Institution - 0018
Singapore, , Singapore
Local Institution - 0044
Singapore, , Singapore
Local Institution - 0037
Seongnam-si, Gyeonggido, South Korea
Local Institution - 0056
Seoul, , South Korea
Local Institution - 0032
Santiago de Compostela, A Coruña, Spain
Local Institution - 0007
Santander, Cantabria, Spain
Local Institution - 0067
Madrid, Sede Madrid, Spain
Local Institution - 0053
Madrid, , Spain
Local Institution - 0038
Pamplona, , Spain
Local Institution - 0040
Zaragoza, , Spain
Local Institution - 0043
District Taichung City, Tai Zhong Shi, Taiwan
Local Institution - 0024
Taichung, , Taiwan
Local Institution - 0046
Taipei, , Taiwan
Local Institution - 0049
Taipei, , Taiwan
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-003606-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1267-1579
Identifier Type: OTHER
Identifier Source: secondary_id
CA224-106
Identifier Type: -
Identifier Source: org_study_id
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