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
- Conditions
- Hepatocellular CarcinomaHepatomaLiver Cell Carcinoma, AdultLiver Cell CarcinomaLiver Cancer, Adult
- Interventions
- Registration Number
- NCT04567615
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 266
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C : Nivolumab + Relatlimab Dose 2 Relatlimab - Arm B : Nivolumab + Relatlimab Dose 1 Nivolumab - Arm B : Nivolumab + Relatlimab Dose 1 Relatlimab - Arm A : Nivolumab Nivolumab - Arm C : Nivolumab + Relatlimab Dose 2 Nivolumab -
- Primary Outcome Measures
Name Time Method Objective Response Rate(ORR) Assessed by BICR From randomization to primary completion date (Approximately 29.5 Months) Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set.
BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first.
For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
- Secondary Outcome Measures
Name Time Method Disease Control Rate Assessed by BICR From randomization to primary completion date (Approximately 29.5 Months) Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Duration of Response Assessed by BICR From randomization to primary completion date (Approximately 29.5 Months) Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first.
Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.Progression Free Survival(PFS) Assessed by BICR From randomization to primary completion date (Approximately 29.5 Months) PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first.
Participants who die without a reported progression will be considered to have progressed on the date of their death.Objective Response Rate Assessed by Investigator From randomization to primary completion date (Approximately 29.5 Months) Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set.
BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first.
For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.Disease Control Rate Assessed by Investigator From randomization to primary completion date (Approximately 29.5 Months) Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Duration of Response Assessed by Investigator From randomization to primary completion date (Approximately 29.5 Months) Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first.
Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.Progression Free Survival(PFS) Assessed by Investigator From randomization to primary completion date (Approximately 29.5 Months) PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first.
Participants who die without a reported progression will be considered to have progressed on the date of their death.Overall Survival (OS) From randomization to primary completion date (Approximately 29.5 Months) Overall survival (OS) is defined as the time from randomization to the date of death from any cause.
Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.Number of Participants With Adverse Events From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. Number of participants with an Adverse Event.
An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.Number of Participants With Serious Adverse Events From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. Number of participants with Serious Adverse Events
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.Number of Participants With Adverse Events Leading to Discontinuation From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. Number of participants with Adverse Events Leading to Discontinuation
Death Summary From randomization to primary completion date (Approximately 29.5 Months) Number of participants who died.
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. Number of participants with clinical laboratory abnormalities in specific liver tests
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. Number of participants with clinical laboratory abnormalities in thyroid tests
Trial Locations
- Locations (65)
Local Institution - 0016
🇧🇷Barretos, SAO Paulo, Brazil
Local Institution - 0010
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0019
🇦🇷Buenos Aires, Distrito Federal, Argentina
Local Institution - 0017
🇦🇷Rosario, Santa Fe, Argentina
Local Institution - 0063
🇦🇷San Miguel de Tucumán, Tucuman, Argentina
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, Brazil
Local Institution - 0024
🇨🇱Temuco, Araucanía, Chile
Local Institution - 0029
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0018
🇨🇱Santiago, Región Metropolitana De Santiago, 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, China
Local Institution - 0117
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0048
🇨🇿Brno, Czechia
Local Institution - 0047
🇨🇿Hradec Kralove, Czechia
Local Institution - 0046
🇨🇿Prague, Czechia
Local Institution - 0069
🇫🇷Vandoeuvre 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
🇯🇵Osaka-sayama, Osaka, Japan
Local Institution - 0075
🇯🇵Ishikawa, Japan
Local Institution - 0071
🇯🇵Kyoto, Japan
Local Institution - 0011
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Local Institution - 0020
🇰🇷Seongnam-si, Korea, Republic of
Local Institution - 0043
🇰🇷Seoul, Korea, Republic of
Local Institution - 0101
🇲🇽San Luis Potosí, SAN LUIS Potosi, Mexico
Local Institution - 0100
🇲🇽Cuauhtémoc, Mexico
Local Institution - 0106
🇲🇽Oaxaca, Mexico
Local Institution - 0003
🇳🇿Auckland, New Zealand
Local Institution - 0013
🇵🇱Krakow, Małopolskie, Poland
Local Institution - 0012
🇵🇱Bytom, Poland
Local Institution - 0009
🇵🇱Mysowice, Poland
Local Institution - 0039
🇵🇱Warszawa, Poland
Local Institution - 0038
🇷🇴Craiova, Dolj, Romania
Local Institution - 0037
🇷🇴București, Romania
Local Institution - 0036
🇷🇴Cluj, Romania
Local Institution - 0070
🇷🇴Suceava, Romania
Local Institution - 0001
🇸🇬Singapore, Central Singapore, Singapore
Local Institution - 0004
🇸🇬Singapore, Singapore
Local Institution - 0050
🇪🇸San Sebastian, Gipuzkoa, Spain
Local Institution - 0066
🇪🇸Barcelona, Spain
Local Institution - 0073
🇪🇸Cordoba, 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 City, Taiwan
Local Institution - 0042
🇨🇳Taipei, Taiwan
Local Institution - 0032
🇨🇳Taoyuan, Taiwan
Local Institution - 0089
🇹🇷Ankara, Turkey
Local Institution - 0090
🇹🇷Edirne, Turkey
Local Institution - 0091
🇹🇷Kadiköy/Istanbul, Turkey