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

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ClinicalTrials.gov Identifier: NCT02576509
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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

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 : June 9, 2019
Estimated Study Completion Date : July 14, 2020

Resource links provided by the National Library of Medicine


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



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

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


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

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

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

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


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Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Ucla-Division Of Hematology/Oncology
Los Angeles, California, United States, 90095
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
University Of California San Francisco
San Francisco, California, United States, 94143
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Icahn School Of Medicine At Mount Sinai
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
The University Of Texas Health Science Center
San Antonio, Texas, United States, 78229
Scott & White Memorial Hospital And Clinic
Temple, Texas, United States, 76508
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre Clayton
Clayton, Victoria, Australia, 3168
Austin Hospital
Heidelberg, Victoria, Australia, 3084
The Alfred Hospital
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Austria
Universitaetsklinikum Graz
Graz, Austria, 8036
AKH Wien
Wien, Austria, 1090
Belgium
Local Institution
Bruxelles, Belgium, 1000
Local Institution
Leuven, Belgium, 3000
Local Institution
Liege, Belgium, 4000
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency-Vancouver Ctr
Vancouver, British Columbia, Canada, V5Z4E6
Canada
CHU de Quebec - Universite Laval
Quebec, Canada, G1R 2J6
China, Anhui
Local Institution
Hefei, Anhui, China, 230061
China, Beijing
Local Institution
Beijing, Beijing, China, 100050
Local Institution
Beijing, Beijing, China, 100071
Local Institution
Beijing, Beijing, China, 100142
China, Fujian
Local Institution
Fuzhou, Fujian, China, 350025
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510060
Local Institution
Guangzhou, Guangdong, China, 510080
Local Institution
Guangzhou, Guangdong, China, 510515
China, Guangxi
Local Institution
Nanning, Guangxi, China, 530021
China, Heilongjiang
Local Institution
Harbin, Heilongjiang, China, 155040
China, Hunan
Local Institution
Changsha, Hunan, China, 410013
China, Jiangsu
Local Institution
Changzhou, Jiangsu, China, 213003
Local Institution
Nanjing, Jiangsu, China, 210002
China, Jilin
Local Institution
Chang Chun, Jilin, China, 130012
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Dalian, Liaoning, China, 116000
China, Shan3xi
Local Institution
Xi'an, Shan3xi, China, 710038
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200032
China, Tianjin
Local Institution
Tianjin, Tianjin, China, 300060
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310003
Local Institution
Hangzhou, Zhejiang, China, 310022
Czechia
Klinika komplexni onkologicke pece
Brno, Czechia, 656 53
Klinika onkologie a radioterapie
Hradec Kralove, Czechia, 500 05
Onkologicka klinika
Olomouc, Czechia, 779 00
France
Local Institution
La Tronche, France, 38700
Local Institution
Lille Cedex, France, 59037
Local Institution
Lyon, France, 69004
Local Institution
Montpellier Cedex, France, 34295
Local Institution
Paris Cedex 13, France, 75651
Local Institution
Pessac, France, 33604
Local Institution
Rennes Cedex, France, 35042
Local Institution
Toulouse Cedex 9, France, 31059
Germany
Charite Campus Virchow Klinikum
Berlin, Germany, 13353
Kliniken Essen-Mitte/Huyssens-Stift
Essen, Germany, 45136
Klinikum Der Johann Wolfgang Goethe-Universitat
Frankfurt, Germany, 60590
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Johannes -Gutenberg Universitat
Mainz, Germany, 55131
Klinikum Grosshadern
Munich, Germany, 81366
Universitaetsklinikum Regensburg
Regensburg, Germany, 93053
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Hong Kong
Local Institution
Hong Kong, Hong Kong
Israel
Local Institution
Haifa, Israel, 31096
Local Institution
Jerusalem, Israel, 91120
Local Institution
Petah-tikva, Israel, 49100
Local Institution
Tel Aviv, Israel, 64239
Italy
Local Institution
Benevento, Italy, 82100
Local Institution
Bergamo, Italy
Local Institution
Milano, Italy, 20133
Local Institution
Orbassano, Italy, 10043
Local Institution
Siena, Italy, 53100
Japan
Local Institution
Chiba City, Chiba, Japan, 2608670
Local Institution
Matsuyama-shi, Ehime, Japan, 7900024
Local Institution
Kurume-shi, Fukuoka, Japan, 8300011
Local Institution
Ogaki-shi, Gifu, Japan, 5038502
Local Institution
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution
Sapporo-shi, Hokkaido, Japan, 0600033
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Kanazawa-shi, Ishikawa, Japan, 9208641
Local Institution
Kawasaki-shi, Kanagawa, Japan, 2138587
Local Institution
Yokohama-shi, Kanagawa, Japan, 2320024
Local Institution
Yokohama-shi, Kanagawa, Japan, 2418515
Local Institution
Kyoto-shi, Kyoto, Japan, 6028566
Local Institution
Osaka-Sayama-Shi, Osaka, Japan, 5898511
Local Institution
Suita-shi, Osaka, Japan, 5650871
Local Institution
Saga-shi, Saga, Japan, 8408571
Local Institution
Chiyoda-ku, Tokyo, Japan, 101-0062
Local Institution
Mitaka-shi, Tokyo, Japan, 181-8611
Local Institution
Musashino-shi, Tokyo, Japan, 1808610
Local Institution
Shinjuku-ku, Tokyo, Japan, 1628655
Korea, Republic of
Local Institution
Daegu, Korea, Republic of, 41944
Local Institution
Gyeonggi-do, Korea, Republic of, 410-769
Local Institution
Hwasun-gun, Korea, Republic of, 519-763
Local Institution
Seoul, Korea, Republic of, 03080
Local Institution
Seoul, Korea, Republic of, 05505
Local Institution
Seoul, Korea, Republic of, 06351
Local Institution
Seoul, Korea, Republic of, 06591
Local Institution
Seoul, Korea, Republic of, 120-752
Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote
Gdansk, Poland, 80-952
Klinika Gastroenterologii Onkologicznej
Warszawa, Poland, 02-781
Oddzial Onkologii
Wroclaw, Poland, 50-556
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Singapore
Local Institution
Singapore, Singapore, 169610
Local Institution
Singapore, Singapore, 308433
Spain
Local Institution
Alicante, Spain, 03010
Local Institution
Majadahonda - Madrid, Spain, 28222
Local Institution
Pamplona, Spain, 31008
Local Institution
Santiago Compostela, Spain, 15706
Sweden
Local Institution
Goteborg, Sweden, 413 45
Local Institution
Stockholm, Sweden, 141 86
Switzerland
Universitaetsspital Basel
Basel, Switzerland, 4031
Inselspital Bern
Bern, Switzerland
Taiwan
Local Institution
Kaohsiung, Taiwan, 833
Local Institution
Taichung, Taiwan, 40447
Local Institution
Tainan, Taiwan, 704
Local Institution
Tainan, Taiwan, 736
Local Institution
Taipei, Taiwan, 10048
Local Institution
Taipei, Taiwan, 11217
Local Institution
Taoyuan, Taiwan, 333
United Kingdom
Local Institution
London, Greater London, United Kingdom, NW3 2QG
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Local Institution
Wirral, Merseyside, United Kingdom, L63 4JY
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb

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: October 11, 2018
Last Verified: September 2018

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
Nivolumab
Sorafenib
Antibodies, Monoclonal
Niacinamide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances