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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04567615
Other study ID # CA224-073
Secondary ID 2018-003151-38U1
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 4, 2021
Est. completion date September 25, 2024

Study information

Verified date March 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  China,  Czechia,  France,  Hong Kong,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Romania,  Singapore,  Spain,  Taiwan,  Turkey, 

Outcome

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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