A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Registration Number
- NCT05337137
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 162
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Placebo + Nivolumab + Bevacizumab Placebo - Arm B: Placebo + Nivolumab + Bevacizumab Bevacizumab - Arm A: Relatlimab + Nivolumab + Bevacizumab Nivolumab - Arm B: Placebo + Nivolumab + Bevacizumab Nivolumab - Arm A: Relatlimab + Nivolumab + Bevacizumab Bevacizumab - Arm A: Relatlimab + Nivolumab + Bevacizumab Relatlimab -
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) Up to 6 weeks Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Assessed up to 3 years
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive Assessed up to 3 years PFS by BICR per RECIST v1.1 in all randomized participants Assessed up to 3 years ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive Assessed up to 3 years Overall Survival (OS) of all randomized participants Assessed up to 3 years OS of all randomized participants that are LAG-3 positive Assessed up to 3 years Number of participants with adverse events (AEs) Up to 135 days after participant's last dose
Trial Locations
- Locations (61)
Local Institution - 0042
🇺🇸Los Angeles, California, United States
Local Institution - 0039
🇺🇸Los Angeles, California, United States
Local Institution - 0034
🇺🇸San Francisco, California, United States
Local Institution - 0030
🇺🇸Washington, District of Columbia, United States
Local Institution - 0059
🇺🇸Baltimore, Maryland, United States
Local Institution - 0060
🇺🇸Boston, Massachusetts, United States
Local Institution - 0065
🇺🇸Boston, Massachusetts, United States
Local Institution - 0062
🇺🇸Bronx, New York, United States
Local Institution - 0061
🇺🇸New York, New York, United States
Local Institution - 0033
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0045
🇦🇺Camperdown, New South Wales, Australia
Local Institution - 0022
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0026
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0013
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0017
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0025
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0009
🇨🇦Toronto, Ontario, Canada
Local Institution - 0064
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0066
🇨🇳Xian, Shan3xi, China
Local Institution - 0021
🇫🇷Avignon, Cedex 9, France
Local Institution - 0012
🇫🇷Grenoble, France
Local Institution - 0001
🇫🇷Nice, France
Local Institution - 0002
🇫🇷Reims, France
Local Institution - 0008
🇫🇷Rennes, France
Local Institution - 0054
🇫🇷Suresnes, France
Local Institution - 0051
🇩🇪Duesseldorf, North Rhine-Westphalia, Germany
Local Institution - 0035
🇩🇪Frankfurt, Germany
Local Institution - 0057
🇩🇪Mainz, Germany
Local Institution - 0055
🇩🇪Munich, Germany
Local Institution - 0004
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Local Institution - 0031
ðŸ‡ðŸ‡°Shatin, Hong Kong
Local Institution - 0036
🇮🇹Milano, Italy
Local Institution - 0003
🇮🇹Padova, Italy
Local Institution - 0010
🇮🇹Roma, Italy
Local Institution - 0047
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0048
🇯🇵Matsuyama-shi, Ehime, Japan
Local Institution - 0058
🇯🇵Kanazawa, Ishikawa, Japan
Local Institution - 0050
🇯🇵Yokohama-shi, Kanagawa, Japan
Local Institution - 0041
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0063
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0037
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Local Institution - 0056
🇰🇷Seoul, Korea, Republic of
Local Institution - 0028
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Local Institution - 0016
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0023
🇵🇱Gdansk, Poland
Local Institution - 0052
🇵🇷Rio Piedras, Puerto Rico
Local Institution - 0019
🇵🇷San Juan, Puerto Rico
Local Institution - 0029
🇸🇬Singapore, Singapore
Local Institution - 0027
🇸🇬Singapore, Singapore
Local Institution - 0018
🇸🇬Singapore, Singapore
Local Institution - 0044
🇸🇬Singapore, Singapore
Local Institution - 0032
🇪🇸Santiago de Compostela, A Coruña, Spain
Local Institution - 0007
🇪🇸Santander, Cantabria, Spain
Local Institution - 0067
🇪🇸Madrid, Sede Madrid, Spain
Local Institution - 0053
🇪🇸Madrid, Spain
Local Institution - 0038
🇪🇸Pamplona, Spain
Local Institution - 0040
🇪🇸Zaragoza, Spain
Local Institution - 0043
🇨🇳District Taichung City, Tai Zhong Shi, Taiwan
Local Institution - 0024
🇨🇳Taichung, Taiwan
Local Institution - 0046
🇨🇳Taipei, Taiwan
Local Institution - 0049
🇨🇳Taipei, Taiwan