Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
| Verified date | March 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor therapy.
| Status | Active, not recruiting |
| Enrollment | 266 |
| Est. completion date | September 25, 2024 |
| Est. primary completion date | August 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: - Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation - 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 Key Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma - 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 Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0019 | Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0010 | Ciudad de Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0017 | Rosario | Santa Fe |
| Argentina | Local Institution - 0063 | San Miguel de Tucumán | Tucuman |
| Brazil | Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica | Barretos | SAO Paulo |
| Brazil | Local Institution - 0025 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0060 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology | Ribeirao Preto | SAO Paulo |
| Brazil | Local Institution - 0015 | São Paulo | SAO Paulo |
| Chile | Local Institution - 0018 | Santiago | Metropolitana |
| Chile | Local Institution - 0029 | Santiago | Metropolitana |
| Chile | Local Institution - 0024 | Temuco | Araucanía |
| China | Local Institution - 0114 | Changsha | Hunan |
| China | Local Institution - 0117 | Hangzhou | Zhejiang |
| China | Local Institution - 0113 | Harbin | Heilongjiang |
| China | Local Institution - 0107 | Shanghai | Shanghai |
| China | Local Institution - 0108 | Xi'an | Shan3xi |
| China | Local Institution - 0118 | Xi'an | Shaanxi |
| Czechia | Local Institution - 0048 | Brno | |
| Czechia | Local Institution - 0047 | Hradec Kralove | |
| Czechia | Local Institution - 0046 | Prague | |
| France | Local Institution - 0068 | Clichy | |
| France | Local Institution - 0105 | Grenoble | |
| France | Local Institution - 0074 | Lyon | |
| France | Local Institution - 0067 | Pessac | |
| France | Local Institution - 0069 | Vandoeuvre lès Nancy | Meurthe-et-Moselle |
| Hong Kong | Local Institution - 0077 | Hksar | |
| Hong Kong | Local Institution - 0079 | Shatin | |
| Japan | Local Institution - 0075 | Ishikawa | |
| Japan | Local Institution - 0071 | Kyoto | |
| Japan | Local Institution - 0072 | Matsuyama | Ehime |
| Japan | Local Institution - 0045 | Osaka-sayama | Osaka |
| Japan | Local Institution - 0054 | Yokohama | Kanagawa |
| Japan | Local Institution - 0076 | Yokohama | Kanagawa |
| Korea, Republic of | Local Institution - 0020 | Seongnam-si | |
| Korea, Republic of | Local Institution - 0011 | Seoul | Seoul-teukbyeolsi |
| Korea, Republic of | Local Institution - 0043 | Seoul | |
| Mexico | Local Institution - 0100 | Cuauhtémoc | |
| Mexico | Local Institution - 0106 | Oaxaca | |
| Mexico | Local Institution - 0101 | San Luis Potosí | SAN LUIS Potosi |
| New Zealand | Local Institution - 0003 | Auckland | |
| Poland | Local Institution - 0012 | Bytom | |
| Poland | Local Institution - 0013 | Krakow | Malopolskie |
| Poland | Local Institution - 0009 | Mysowice | |
| Poland | Local Institution - 0039 | Warszawa | |
| Romania | Local Institution - 0037 | Bucure?ti | |
| Romania | Local Institution - 0036 | Cluj | |
| Romania | Local Institution - 0038 | Craiova | |
| Romania | Local Institution - 0070 | Suceava | |
| Singapore | Local Institution - 0001 | Singapore | Central Singapore |
| Singapore | Local Institution - 0004 | Singapore | |
| Spain | Local Institution - 0066 | Barcelona | |
| Spain | Local Institution - 0073 | Cordoba | |
| Spain | Local Institution - 0049 | Madrid | |
| Spain | Local Institution - 0051 | Madrid | |
| Spain | Local Institution - 0058 | Pamplona | |
| Spain | Local Institution - 0050 | San Sebastian | Gipuzkoa |
| Taiwan | Local Institution - 0041 | Taichung | |
| Taiwan | Local Institution - 0034 | Tainan | |
| Taiwan | Local Institution - 0042 | Taipei | |
| Taiwan | Local Institution - 0031 | Taipei City | |
| Taiwan | Local Institution - 0032 | Taoyuan | |
| Turkey | Local Institution - 0089 | Ankara | |
| Turkey | Local Institution - 0090 | Edirne | |
| Turkey | Local Institution - 0091 | Kadiköy/Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Argentina, Brazil, Chile, China, Czechia, France, Hong Kong, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Romania, Singapore, Spain, Taiwan, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 2 years | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to approximately 2.5 years | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to approximately 2.5 years | ||
| Secondary | Incidence of AEs leading to discontinuation | Up to approximately 2.5 years | ||
| Secondary | Incidence of death | Up to approximately 2.5 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to approximately 2.5 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to approximately 2.5 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to approximately 2.5 years | ||
| Secondary | Disease control rate (DCR) assessed by BICR per RECIST v1.1 | Up to 2 years until progression of disease | ||
| Secondary | Duration of response (DOR) assessed by BICR per RECIST v1.1 | Up to 2 years after first dose of treatment | ||
| Secondary | Progression-free survival assessed by BICR per RECIST v1.1 | Up to 2 years after first dose of treatment | ||
| Secondary | ORR assessed by investigator per RECIST v1.1 | Up to 2 years after first dose of treatment | ||
| Secondary | DCR assessed by investigator per RECIST v1.1 | Up to 2 years after first dose of treatment | ||
| Secondary | DOR assessed by investigator per RECIST v1.1 | Up to 2 years after first dose of treatment | ||
| Secondary | PFS assessed by investigator per RECIST v1.1 | Up to 2 years after first dose of treatment | ||
| Secondary | Overall survival (OS) | Up to 3 years after first dose of treatment |
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