Clinical trial NCT05337137: A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
Official title: A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular Carcinoma
HCC
Liver Cancer
Relatlimab
Nivolumab
Bevacizumab
First line HCC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 162
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 safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
* Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
* Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

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

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: Up to 6 weeks
measure: Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Assessed up to 3 years
Secondary outcomes:
measure: Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive
timeFrame: Assessed up to 3 years
measure: PFS by BICR per RECIST v1.1 in all randomized participants
timeFrame: Assessed up to 3 years
measure: ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive
timeFrame: Assessed up to 3 years
measure: Overall Survival (OS) of all randomized participants
timeFrame: Assessed up to 3 years
measure: OS of all randomized participants that are LAG-3 positive
timeFrame: Assessed up to 3 years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 135 days after participant's last dose
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0042
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0039
state: California
city: San Francisco
country: United States
facility: Local Institution - 0034
state: California
city: Washington
country: United States
facility: Local Institution - 0030
state: District of Columbia
city: Baltimore
country: United States
facility: Local Institution - 0059
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0060
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0065
state: Massachusetts
city: Bronx
country: United States
facility: Local Institution - 0062
state: New York
city: New York
country: United States
facility: Local Institution - 0061
state: New York
city: Milwaukee
country: United States
facility: Local Institution - 0033
state: Wisconsin
city: Camperdown
country: Australia
facility: Local Institution - 0045
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution - 0022
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution - 0026
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0013
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0017
state: Western Australia
city: Edmonton
country: Canada
facility: Local Institution - 0025
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 0009
state: Ontario
city: Guangzhou
country: China
facility: Local Institution - 0064
state: Guangdong
city: Xian
country: China
facility: Local Institution - 0066
state: Shan3xi
city: Avignon
country: France
facility: Local Institution - 0021
state: Cedex 9
city: Grenoble
country: France
facility: Local Institution - 0012
city: Nice
country: France
facility: Local Institution - 0001
city: Reims
country: France
facility: Local Institution - 0002
city: Rennes
country: France
facility: Local Institution - 0008
city: Suresnes
country: France
facility: Local Institution - 0054
city: Duesseldorf
country: Germany
facility: Local Institution - 0051
state: North Rhine-Westphalia
city: Frankfurt
country: Germany
facility: Local Institution - 0035
city: Mainz
country: Germany
facility: Local Institution - 0057
city: Munich
country: Germany
facility: Local Institution - 0055
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0004
city: Shatin
country: Hong Kong
facility: Local Institution - 0031
city: Milano
country: Italy
facility: Local Institution - 0036
city: Padova
country: Italy
facility: Local Institution - 0003
city: Roma
country: Italy
facility: Local Institution - 0010
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0047
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Local Institution - 0048
state: Ehime
city: Kanazawa
country: Japan
facility: Local Institution - 0058
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Local Institution - 0050
state: Kanagawa
city: Osakasayama
country: Japan
facility: Local Institution - 0041
state: Osaka
city: Chuo-ku
country: Japan
facility: Local Institution - 0063
state: Tokyo
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0037
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0056
city: Bydgoszcz
country: Poland
facility: Local Institution - 0028
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Local Institution - 0016
state: Mazowieckie
city: Gdansk
country: Poland
facility: Local Institution - 0023
city: Rio Piedras
country: Puerto Rico
facility: Local Institution - 0052
city: San Juan
country: Puerto Rico
facility: Local Institution - 0019
city: Singapore
country: Singapore
facility: Local Institution - 0029
city: Singapore
country: Singapore
facility: Local Institution - 0027
city: Singapore
country: Singapore
facility: Local Institution - 0018
city: Singapore
country: Singapore
facility: Local Institution - 0044
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0032
state: A Coruña
city: Santander
country: Spain
facility: Local Institution - 0007
state: Cantabria
city: Madrid
country: Spain
facility: Local Institution - 0067
state: Sede Madrid
city: Madrid
country: Spain
facility: Local Institution - 0053
city: Pamplona
country: Spain
facility: Local Institution - 0038
city: Zaragoza
country: Spain
facility: Local Institution - 0040
city: District Taichung City
country: Taiwan
facility: Local Institution - 0043
state: Tai Zhong Shi
city: Taichung
country: Taiwan
facility: Local Institution - 0024
city: Taipei
country: Taiwan
facility: Local Institution - 0046
city: Taipei
country: Taiwan
facility: Local Institution - 0049
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: