Carcinoma, Hepatocellular Clinical Trial
— RELATIVITY-106Official 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
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).
| Status | Recruiting |
| Enrollment | 162 |
| Est. completion date | December 15, 2026 |
| Est. primary completion date | June 4, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0022 | Adelaide | South Australia |
| Australia | Local Institution - 0045 | Camperdown | New South Wales |
| Australia | Olivia Newton-John Cancer Research Institute | Heidelberg | Victoria |
| Australia | St. Vincents Hospital | Melbourne | Victoria |
| Australia | Local Institution - 0017 | Nedlands | Western Australia |
| Canada | Local Institution - 0025 | Edmonton | Alberta |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| China | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
| China | Xian International Medical Center Hospital | Xian | Shan3xi |
| France | Local Institution - 0021 | Avignon | Cedex 9 |
| France | Local Institution | Bondy | |
| France | Local Institution - 0012 | Grenoble | |
| France | Centre Hospitalier Universitaire de Nice Hopital l Archet (Albert Tran) | Nice | |
| France | Local Institution - 0002 | Reims | |
| France | Centre Eugene Marquis | Rennes | |
| France | Local Institution - 0054 | Suresnes | |
| Germany | Universitaetsklinikum Duesseldorf | Duesseldorf | North Rhine-Westphalia |
| Germany | University Hospital Frankfurt | Frankfurt | |
| Germany | Universitaetsmedizin der Johannes Gutenberg-University Mainz | Mainz | |
| Germany | Local Institution - 0055 | Munich | |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| Hong Kong | Local Institution - 0031 | Shatin | |
| Italy | Local Institution - 0036 | Milano | MI |
| Italy | Oncology Institute Veneto IOV-IRCCS | Padova | |
| Italy | Local Institution - 0010 | Roma | |
| Italy | Local Institution - 0020 | Rozzano | Milano |
| Japan | Kanazawa University Hospital | Kanazawa-shi | Ishikawa |
| Japan | Local Institution - 0047 | Kashiwa-shi | Chiba |
| Japan | Ehime Prefectural Central Hospital | Matsuyama | Ehime |
| Japan | Local Institution - 0041 | Osakasayama | Osaka |
| Japan | Local Institution - 0063 | Tokyo | |
| Japan | Yokohama City University Medical Center | Yokohama-shi | Kanagawa |
| Korea, Republic of | Local Institution - 0037 | Seongnam-si | Gyeonggido |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Poland | Centrum Onkologii im. Prof. Franciszka Aukaszczyka, Ambulatorium Chemioterapii | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Local Institution - 0023 | Gdansk | Pomorskie |
| Poland | M Sklodowska Curie Memorial National Cancer Institute | Warszawa | Mazowieckie |
| Puerto Rico | Pan American Center for Oncology Trials, LLC | Rio Piedras | |
| Puerto Rico | FDI Clinical Research | San Juan | |
| Puerto Rico | Local Institution - 0019_NA | San Juan | |
| Singapore | Local Institution - 0027 | Singapore | |
| Singapore | Local Institution - 0044 | Singapore | |
| Singapore | National Cancer Centre | Singapore | |
| Singapore | Tan Tock Seng Hospital | Singapore | |
| Spain | Clinica Universidad de Navarra | Madrid | Sede Madrid |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Clinica Universidad de Navarra | Pamplona | |
| Spain | Local Institution - 0007 | Santander | Cantabria |
| Spain | Hospital Clnico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| Taiwan | Local Institution - 0043 | District Taichung City | Tai Zhong Shi |
| Taiwan | Taichung Veterans General Hospital | Taichung | |
| Taiwan | Local Institution - 0049 | Taipei | |
| Taiwan | National Taiwan University Hospital NTUH | Taipei | |
| United States | Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Harvard Medical School - Massachusetts General Hospital MGH - Cancer Center | Boston | Massachusetts |
| United States | Albert Einstein School of Medicine Montefiore | Bronx | New York |
| United States | University of California - Los Angeles | Los Angeles | California |
| United States | USC Norris Comprehensive Cancer Center | Los Angeles | California |
| United States | Medical College of Wisconsin/ Froedtert Hospital | Milwaukee | Wisconsin |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | California Pacific Hematology Oncology Associates | San Francisco | California |
| United States | Georgetown University Medical Center - Lombardi Comprehensive Cancer Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Canada, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Singapore, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) | Up to 6 weeks | ||
| Primary | 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 | 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 | ||
| Secondary | PFS by BICR per RECIST v1.1 in all randomized participants | Assessed up to 3 years | ||
| Secondary | ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive | Assessed up to 3 years | ||
| Secondary | Overall Survival (OS) of all randomized participants | Assessed up to 3 years | ||
| Secondary | OS of all randomized participants that are LAG-3 positive | Assessed up to 3 years | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 135 days after participant's last dose |
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