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An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02576509
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

NOTE: Global recruitment is complete but enrollment is ongoing for the China sub-study.

The Completion Date for the Primary Outcome Measure is expected in October 2018.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Nivolumab Drug: Sorafenib Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 726 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 25, 2015
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : June 22, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab specified dose on specified days
Drug: Nivolumab
Active Comparator: Sorafenib
Sorafenib specified dose on specified days
Drug: Sorafenib


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 33 months ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Approximately 33 months ]
  2. Progression-Free Survival (PFS) [ Time Frame: Approximately 33 months ]
  3. Programmed death (PD)-L1 expression [ Time Frame: Approximately 33 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

NOTE: Global recruitment is complete but enrollment is ongoing for the China sub-study

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Prior liver transplant
  • Active, known, or suspected autoimmune disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576509


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham Terminated
Birmingham, Alabama, United States, 35294
United States, California
Ucla-Division Of Hematology/Oncology Active, not recruiting
Los Angeles, California, United States, 90095
Pacific Hematology Oncology Associates Active, not recruiting
San Francisco, California, United States, 94115
University Of California San Francisco Active, not recruiting
San Francisco, California, United States, 94143
United States, Illinois
University Of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Louisiana
Ochsner Clinic Foundation Active, not recruiting
New Orleans, Louisiana, United States, 70121
United States, New York
Icahn School Of Medicine At Mount Sinai Active, not recruiting
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University Of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Ut Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
The University Of Texas Health Science Center Active, not recruiting
San Antonio, Texas, United States, 78229
Scott & White Memorial Hospital And Clinic Active, not recruiting
Temple, Texas, United States, 76508
United States, Washington
Virginia Mason Medical Center Active, not recruiting
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance Active, not recruiting
Seattle, Washington, United States, 98109
United States, Wisconsin
University Of Wisconsin Active, not recruiting
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Royal Prince Alfred Hospital Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Royal Adelaide Hospital Active, not recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre Clayton Active, not recruiting
Clayton, Victoria, Australia, 3168
Austin Hospital Active, not recruiting
Heidelberg, Victoria, Australia, 3084
The Alfred Hospital Active, not recruiting
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Austria
Universitaetsklinikum Graz Active, not recruiting
Graz, Austria, 8036
Akh Wien Active, not recruiting
Wien, Austria, 1090
Belgium
Local Institution Active, not recruiting
Bruxelles, Belgium, 1000
Local Institution Active, not recruiting
Leuven, Belgium, 3000
Local Institution Active, not recruiting
Liege, Belgium, 4000
Canada, Alberta
Tom Baker Cancer Centre Active, not recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency-Vancouver Ctr Active, not recruiting
Vancouver, British Columbia, Canada, V5Z4E6
Canada
Chu De Quebec - Universite Laval Active, not recruiting
Quebec, Canada, G1R 2J6
China, Anhui
Local Institution Recruiting
Hefei, Anhui, China, 230061
Contact: Site 0164         
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100050
Contact: Site 0139         
Local Institution Recruiting
Beijing, Beijing, China, 100071
Contact: Site 0137         
Local Institution Recruiting
Beijing, Beijing, China, 100142
Contact: Site 0140         
Local Institution Recruiting
Beijing, Beijing, China, 100142
Contact: Site 0141         
China, Fujian
Local Institution Not yet recruiting
Fuzhou, Fujian, China, 350025
Contact: Site 0152         
China, Guangdong
Local Institution Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Site 0161         
Local Institution Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site 0157         
Local Institution Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Site 0144         
China, Guangxi
Local Institution Recruiting
Nanning, Guangxi, China, 530021
Contact: Site 0158         
China, Heilongjiang
Local Institution Recruiting
Harbin, Heilongjiang, China, 155040
Contact: Site 0142         
China, Hunan
Local Institution Not yet recruiting
Changsha, Hunan, China, 410000
Contact: Site 0162         
Local Institution Recruiting
Changsha, Hunan, China, 410013
Contact: Site 0148         
China, Jiangsu
Local Institution Not yet recruiting
Changzhou, Jiangsu, China, 213003
Contact: Site 0169         
Local Institution Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Site 0135         
China, Jilin
Local Institution Recruiting
Chang Chun, Jilin, China, 130012
Contact: Site 0136         
Local Institution Recruiting
Changchun, Jilin, China, 130021
Contact: Site 0163         
China, Liaoning
Local Institution Recruiting
Dalian, Liaoning, China, 116011
Contact: Site 0166         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0151         
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0145         
China, Shanxi
Local Institution Recruiting
Xi'an, Shanxi, China, 710038
Contact: Site 0138         
China, Tianjin
Local Institution Recruiting
Tianjin, Tianjin, China, 300060
Contact: Site 0159         
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Site 0146         
China
Local Institution Not yet recruiting
Beijing, China, 100021
Contact: Site 0153         
Local Institution Not yet recruiting
Hangzhou, China, 310016
Contact: Site 0147         
Czechia
Klinika Komplexni Onkologicke Pece Active, not recruiting
Brno, Czechia, 656 53
Klinika Onkologie A Radioterapie Active, not recruiting
Hradec Kralove, Czechia, 500 05
Onkologicka Klinika Active, not recruiting
Olomouc, Czechia, 779 00
France
Local Institution Active, not recruiting
La Tronche, France, 38700
Local Institution Active, not recruiting
Lille Cedex, France, 59037
Local Institution Active, not recruiting
Lyon, France, 69004
Local Institution Active, not recruiting
Montpellier Cedex, France, 34295
Local Institution Active, not recruiting
Paris Cedex 13, France, 75651
Local Institution Active, not recruiting
Pessac, France, 33604
Local Institution Active, not recruiting
Rennes Cedex, France, 35042
Local Institution Active, not recruiting
Toulouse Cedex 9, France, 31059
Germany
Charite Campus Virchow Klinikum Active, not recruiting
Berlin, Germany, 13353
Kliniken Essen-Mitte/Huyssens-Stift Active, not recruiting
Essen, Germany, 45136
Klinikum Der Johann Wolfgang Goethe-Universitat Active, not recruiting
Frankfurt, Germany, 60590
Universitatsklinikum Hamburg-Eppendorf Active, not recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Leipzig Active, not recruiting
Leipzig, Germany, 04103
Johannes -Gutenberg Universitat Active, not recruiting
Mainz, Germany, 55131
Klinikum Grosshadern Active, not recruiting
Munich, Germany, 81366
Universitaetsklinikum Regensburg Active, not recruiting
Regensburg, Germany, 93053
Universitaetsklinikum Tuebingen Active, not recruiting
Tuebingen, Germany, 72076
Hong Kong
Local Institution Active, not recruiting
Hong Kong, Hong Kong
Israel
Local Institution Active, not recruiting
Haifa, Israel, 31096
Local Institution Active, not recruiting
Jerusalem, Israel, 91120
Local Institution Active, not recruiting
Petah-tikva, Israel, 49100
Local Institution Active, not recruiting
Tel Aviv, Israel, 64239
Italy
Local Institution Active, not recruiting
Orbassano, Torino, Italy, 10043
Local Institution Active, not recruiting
Benevento, Italy, 82100
Local Institution Active, not recruiting
Bergamo, Italy
Local Institution Active, not recruiting
Milano, Italy, 20133
Local Institution Active, not recruiting
Siena, Italy, 53100
Japan
Local Institution Active, not recruiting
Chiba City, Chiba, Japan, 2608670
Local Institution Active, not recruiting
Matsuyama-shi, Ehime, Japan, 7900024
Local Institution Active, not recruiting
Kurume-shi, Fukuoka, Japan, 8300011
Local Institution Active, not recruiting
Ogaki-shi, Gifu, Japan, 5038502
Local Institution Active, not recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0600033
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution Active, not recruiting
Kanazawa-shi, Ishikawa, Japan, 9208641
Local Institution Active, not recruiting
Kawasaki-shi, Kanagawa, Japan, 2138587
Local Institution Active, not recruiting
Yokohama-shi, Kanagawa, Japan, 2320024
Local Institution Active, not recruiting
Yokohama-shi, Kanagawa, Japan, 2418515
Local Institution Active, not recruiting
Kyoto-shi, Kyoto, Japan, 6028566
Local Institution Active, not recruiting
Osaka-sayama, Osaka, Japan, 589-8511
Local Institution Active, not recruiting
Suita-shi, Osaka, Japan, 5650871
Local Institution Active, not recruiting
Chiyoda-ku, Tokyo, Japan, 101-0062
Local Institution Active, not recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Local Institution Active, not recruiting
Musashino-shi, Tokyo, Japan, 1808610
Local Institution Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 1628655
Korea, Republic of
Local Institution Active, not recruiting
Daegu, Korea, Republic of, 700-721
Local Institution Active, not recruiting
Gyeonggi-do, Korea, Republic of, 410-769
Local Institution Active, not recruiting
Hwasun-gun, Korea, Republic of, 519-763
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 03080
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 05505
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 06351
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 120-752
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 137-701
Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote Active, not recruiting
Gdansk, Poland, 80-952
Klinika Gastroenterologii Onkologicznej Active, not recruiting
Warszawa, Poland, 02-781
Oddzial Onkologii Active, not recruiting
Wroclaw, Poland, 50-556
Russian Federation
Local Institution Active, not recruiting
Moscow, Russian Federation, 115478
Singapore
Local Institution Active, not recruiting
Singapore, Singapore, 169610
Local Institution Active, not recruiting
Singapore, Singapore, 308433
Spain
Local Institution Active, not recruiting
Alicante, Spain, 03010
Local Institution Active, not recruiting
Majadahonda - Madrid, Spain, 28222
Local Institution Active, not recruiting
Pamplona, Spain, 31008
Local Institution Active, not recruiting
Santiago De Compostela, Spain, 15706
Sweden
Local Institution Active, not recruiting
Goteborg, Sweden, 413 45
Local Institution Active, not recruiting
Stockholm, Sweden, 141 86
Switzerland
Universitaetsspital Basel Active, not recruiting
Basel, Switzerland, 4031
Inselspital Bern Active, not recruiting
Bern, Switzerland
Taiwan
Local Institution Active, not recruiting
Kaohsiung County, Taiwan, 83301
Local Institution Active, not recruiting
Taichung, Taiwan, 40447
Local Institution Active, not recruiting
Tainan, Taiwan, 704
Local Institution Active, not recruiting
Tainan, Taiwan, 736
Local Institution Active, not recruiting
Taipei, Taiwan, 10048
Local Institution Active, not recruiting
Taipei, Taiwan, 112
Local Institution Active, not recruiting
Taoyuan, Taiwan, 333
Local Institution Active, not recruiting
Yunlin, Taiwan, 640
United Kingdom
Local Institution Active, not recruiting
London, Greater London, United Kingdom, SE5 9RS
Local Institution Active, not recruiting
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Local Institution Active, not recruiting
Wirral, Merseyside, United Kingdom, L63 4JY
Local Institution Active, not recruiting
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02576509     History of Changes
Other Study ID Numbers: CA209-459
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Nivolumab
Niacinamide
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Immunologic Factors