Clinical trial NCT04567615: 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
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Hepatoma
Liver Cancer, Adult
Liver Cell Carcinoma
Liver Cell Carcinoma, Adult
Keywords: Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
Liver Cancer
Liver Cancer, Adult
Liver Cell Carcinoma
Liver Cell Carcinoma, Adult
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate(ORR) Assessed by BICR
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
Secondary outcomes:
measure: Disease Control Rate Assessed by BICR
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Duration of Response Assessed by BICR
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Progression Free Survival(PFS) Assessed by BICR
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Objective Response Rate Assessed by Investigator
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Disease Control Rate Assessed by Investigator
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Duration of Response Assessed by Investigator
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Progression Free Survival(PFS) Assessed by Investigator
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Overall Survival (OS)
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Number of Participants With Adverse Events
timeFrame: 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.
measure: Number of Participants With Serious Adverse Events
timeFrame: 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.
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: 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.
measure: Death Summary
timeFrame: From randomization to primary completion date (Approximately 29.5 Months)
measure: Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
timeFrame: 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.
measure: Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
timeFrame: 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.
Other outcomes:
Locations:
city: Ciudad de Buenos Aires
country: Argentina
facility: Local Institution - 0010
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0019
state: Distrito Federal
city: Rosario
country: Argentina
facility: Local Institution - 0017
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Local Institution - 0063
state: Tucuman
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0025
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution - 0060
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0016
state: SAO Paulo
city: Ribeirao Preto
country: Brazil
facility: Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 0015
state: SAO Paulo
city: Temuco
country: Chile
facility: Local Institution - 0024
state: Araucanía
city: Santiago
country: Chile
facility: Local Institution - 0029
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0018
state: Región Metropolitana De Santiago
city: Harbin
country: China
facility: Local Institution - 0113
state: Heilongjiang
city: Changsha
country: China
facility: Local Institution - 0114
state: Hunan
city: Xi'an
country: China
facility: Local Institution - 0118
state: Shaanxi
city: Xi'an
country: China
facility: Local Institution - 0108
state: Shan3xi
city: Shanghai
country: China
facility: Local Institution - 0107
state: Shanghai
city: Hangzhou
country: China
facility: Local Institution - 0117
state: Zhejiang
city: Brno
country: Czechia
facility: Local Institution - 0048
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0047
city: Prague
country: Czechia
facility: Local Institution - 0046
city: Vandoeuvre lès Nancy
country: France
facility: Local Institution - 0069
state: Meurthe-et-Moselle
city: Clichy
country: France
facility: Local Institution - 0068
city: Grenoble
country: France
facility: Local Institution - 0105
city: Lyon
country: France
facility: Local Institution - 0074
city: Pessac
country: France
facility: Local Institution - 0067
city: Hksar
country: Hong Kong
facility: Local Institution - 0077
city: Shatin
country: Hong Kong
facility: Local Institution - 0079
city: Matsuyama
country: Japan
facility: Local Institution - 0072
state: Ehime
city: Yokohama
country: Japan
facility: Local Institution - 0054
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution - 0076
state: Kanagawa
city: Osaka-sayama
country: Japan
facility: Local Institution - 0045
state: Osaka
city: Ishikawa
country: Japan
facility: Local Institution - 0075
city: Kyoto
country: Japan
facility: Local Institution - 0071
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0011
state: Seoul-teukbyeolsi
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0020
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0043
city: San Luis Potosí
country: Mexico
facility: Local Institution - 0101
state: SAN LUIS Potosi
city: Cuauhtémoc
country: Mexico
facility: Local Institution - 0100
city: Oaxaca
country: Mexico
facility: Local Institution - 0106
city: Auckland
country: New Zealand
facility: Local Institution - 0003
city: Krakow
country: Poland
facility: Local Institution - 0013
state: Małopolskie
city: Bytom
country: Poland
facility: Local Institution - 0012
city: Mysowice
country: Poland
facility: Local Institution - 0009
city: Warszawa
country: Poland
facility: Local Institution - 0039
city: Craiova
country: Romania
facility: Local Institution - 0038
state: Dolj
city: București
country: Romania
facility: Local Institution - 0037
city: Cluj
country: Romania
facility: Local Institution - 0036
city: Suceava
country: Romania
facility: Local Institution - 0070
city: Singapore
country: Singapore
facility: Local Institution - 0001
state: Central Singapore
city: Singapore
country: Singapore
facility: Local Institution - 0004
city: San Sebastian
country: Spain
facility: Local Institution - 0050
state: Gipuzkoa
city: Barcelona
country: Spain
facility: Local Institution - 0066
city: Cordoba
country: Spain
facility: Local Institution - 0073
city: Madrid
country: Spain
facility: Local Institution - 0051
city: Madrid
country: Spain
facility: Local Institution - 0049
city: Pamplona
country: Spain
facility: Local Institution - 0058
city: Taichung
country: Taiwan
facility: Local Institution - 0041
city: Tainan
country: Taiwan
facility: Local Institution - 0034
city: Taipei City
country: Taiwan
facility: Local Institution - 0031
city: Taipei
country: Taiwan
facility: Local Institution - 0042
city: Taoyuan
country: Taiwan
facility: Local Institution - 0032
city: Ankara
country: Turkey
facility: Local Institution - 0089
city: Edirne
country: Turkey
facility: Local Institution - 0090
city: Kadiköy/Istanbul
country: Turkey
facility: Local Institution - 0091
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: