NCT02576509CompletedPhase 3
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)
Source: ClinicalTrials.gov · Last updated 17 Feb 2025
Brief summary (registry, in English)
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 743 (actual)
- First submitted
- 13 Oct 2015
- Start date
- 7 Dec 2015
- Primary completion date
- 30 May 2019
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT02576509
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 743
- From 7 Dec 2015 to the primary completion date, 30 May 2019
- 138 sites in 22 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 liver transplant
Other illness
- Active, known, or suspected autoimmune disease
- Other protocol-defined inclusion/exclusion criteria apply
Other
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Who the study is looking for
- Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
- Child-Pugh Class A
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (138)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0039 Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Prahran | Australia | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0141 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0163 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0162 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0169 Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Local Institution - 0152 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0157 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0161 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0142 Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Local Institution - 0164 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0158 Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Local Institution - 0145 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0159 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Local Institution - 0065 Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Local Institution - 0085 Coordinator of this site? Confirm its status | Majadahonda - Madrid | Spain | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Santiago Compostela | Spain | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0082 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Benevento | Italy | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Chiyoda-ku | Japan | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0110 Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| Local Institution - 0107 Coordinator of this site? Confirm its status | Kurume-shi | Japan | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Mitaka-shi | Japan | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Musashino-shi | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Ogaki-shi | Japan | Unknown status |
| Local Institution - 0106 Coordinator of this site? Confirm its status | Osaka-Sayama-Shi | Japan | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0112 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Local Institution - 0118 Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0088 Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Local Institution - 0087 Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Kaohsiung County | Taiwan | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Taoyuan County | Taiwan | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Local Institution - 0084 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Washington - Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Scott & White Memorial Hospital and Clinic Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.