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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003606-53 | EudraCT Number | ||
| U1111-1267-1579 | Other Identifier | WHO |
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The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Relatlimab + Nivolumab + Bevacizumab | Experimental |
| |
| Arm B: Placebo + Nivolumab + Bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relatlimab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Up to 6 weeks | |
| Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive | Assessed up to 3 years | |
| PFS by BICR per RECIST v1.1 in all randomized participants | Assessed up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
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
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0042 | Los Angeles | California | 90033 | United States | ||
| Local Institution - 0039 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Nivolumab | Drug | Specified dose on specified days |
|
|
| Bevacizumab | Drug | Specified dose on specified days |
|
|
| Placebo | Other | Specified dose on specified days |
|
| ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive | Assessed up to 3 years |
| Overall Survival (OS) of all randomized participants | Assessed up to 3 years |
| OS of all randomized participants that are LAG-3 positive | Assessed up to 3 years |
| Number of participants with adverse events (AEs) | Up to 135 days after participant's last dose |
| Los Angeles |
| California |
| 90095 |
| United States |
| Local Institution - 0034 | San Francisco | California | 94115 | United States |
| Local Institution - 0030 | Washington D.C. | District of Columbia | 20007 | United States |
| Local Institution - 0059 | Baltimore | Maryland | 21231 | United States |
| Local Institution - 0060 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 0065 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0061 | New York | New York | 10065 | United States |
| Local Institution - 0062 | The Bronx | New York | 10461 | United States |
| Local Institution - 0033 | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution - 0045 | Camperdown | New South Wales | 2050 | Australia |
| Local Institution - 0022 | Adelaide | South Australia | 5000 | Australia |
| Local Institution - 0026 | Heidelberg | Victoria | 3084 | Australia |
| Local Institution - 0013 | Melbourne | Victoria | 3065 | Australia |
| Local Institution - 0017 | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0025 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0009 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0064 | Guangzhou | Guangdong | 510515 | China |
| Local Institution - 0066 | Xi'an | Shan3xi | 710700 | China |
| Local Institution - 0021 | Avignon | Cedex 9 | 84918 | France |
| Local Institution - 0012 | Grenoble | 38043 | France |
| Local Institution - 0001 | Nice | 06202 | France |
| Local Institution - 0002 | Reims | 51092 | France |
| Local Institution - 0008 | Rennes | 35042 | France |
| Local Institution - 0054 | Suresnes | 92151 | France |
| Local Institution - 0051 | DĂĽsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Local Institution - 0035 | Frankfurt | 60590 | Germany |
| Local Institution - 0057 | Mainz | 55131 | Germany |
| Local Institution - 0055 | Munich | 81377 | Germany |
| Local Institution - 0004 | Hong Kong | 0 | Hong Kong |
| Local Institution - 0031 | Shatin | 999077 | Hong Kong |
| Local Institution - 0036 | Milan | 20122 | Italy |
| Local Institution - 0003 | Padova | 35128 | Italy |
| Local Institution - 0010 | Roma | 00168 | Italy |
| Local Institution - 0047 | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution - 0048 | Matsuyama | Ehime | 7900024 | Japan |
| Local Institution - 0058 | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Local Institution - 0050 | Yokohama | Kanagawa | 2320024 | Japan |
| Local Institution - 0041 | Sayama | Osaka | 5898511 | Japan |
| Local Institution - 0063 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Local Institution - 0028 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Local Institution - 0016 | Warsaw | Masovian Voivodeship | 02-034 | Poland |
| Local Institution - 0023 | Gdansk | 80-219 | Poland |
| Local Institution - 0052 | Rio Piedras | PR | 935 | Puerto Rico |
| Local Institution - 0019 | San Juan | 00927 | Puerto Rico |
| Local Institution - 0029 | Singapore | 168583 | Singapore |
| Local Institution - 0027 | Singapore | 217562 | Singapore |
| Local Institution - 0018 | Singapore | 308433 | Singapore |
| Local Institution - 0044 | Singapore | 329563 | Singapore |
| Local Institution - 0037 | Seongnam-si | Gyeonggido | 13496 | South Korea |
| Local Institution - 0056 | Seoul | 138-736 | South Korea |
| Local Institution - 0032 | Santiago de Compostela | A Coruña | 15706 | Spain |
| Local Institution - 0007 | Santander | Cantabria | 39008 | Spain |
| Local Institution - 0067 | Madrid | Sede Madrid | 28027 | Spain |
| Local Institution - 0053 | Madrid | 28046 | Spain |
| Local Institution - 0038 | Pamplona | 31008 | Spain |
| Local Institution - 0040 | Zaragoza | 50009 | Spain |
| Local Institution - 0043 | District Taichung City | Tai Zhong Shi | 404 | Taiwan |
| Local Institution - 0024 | Taichung | 40705 | Taiwan |
| Local Institution - 0046 | Taipei | 10048 | Taiwan |
| Local Institution - 0049 | Taipei | 11217 | Taiwan |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 4, 2026 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000721227 | relatlimab |
| D000077594 | Nivolumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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