NCT05337137CompletedPhase 1/2
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 13 Apr 2022
- Start date
- 5 May 2022
- Primary completion date
- 5 Jul 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05337137
- EU CT number
- 2024-510649-33-00
- EudraCT number
- 2021-003606-53
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 82
- From 5 May 2022 to the primary completion date, 5 Jul 2025
- 61 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogenic stem cell or solid organ transplantation
- Clinically significant ascites as defined by:
- Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment
- Other protocol-defined inclusion/exclusion criteria apply
Other
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Untreated symptomatic central nervous system (CNS) metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0022 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Completed |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Sainte Catherine Institut Du Cancer Avignon-Provence Coordinator of this site? Confirm its status | Avignon Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Completed |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Completed |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Completed |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | District Taichung City | Taiwan | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Local Institution - 0065 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.