A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation



Status:Recruiting
Conditions:Liver Cancer, Liver Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:December 18, 2017
End Date:June 7, 2025
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared
to placebo in participants with HCC who have undergone complete resection or have achieved a
complete response after local ablation, and who are at high risk of recurrence


For more information regarding Bristol Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Participants with a first diagnosis of HCC who have undergone a curative resection or
ablation

- Participants are eligible to enroll if they have non-viral related-HCC, or if they
have HBV-HCC, or HCV-HCC

- Child-Pugh Score 5 or 6

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

- Any evidence of tumor metastasis or co-existing malignant disease

- Participants previously receiving any prior therapy for HCC, including loco-regional
therapies

- Participants who have undergone a liver transplant or those who are in the waiting
list for liver transplantation

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
21
sites
New York, New York 10029
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-9570
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Phone: 206-288-7350
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-647-8902
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Anniston, Alabama 36207
Phone: 2562360055111
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Anniston, AL
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Phone: 404-778-2670
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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Camperdown, New South Wales 2050
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Camperdown,
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-590-3869
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, TX
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Los Angeles, California
Phone: 310-825-7412
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Los Angeles, CA
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Miami, Florida 33442
Phone: 305-243-3174
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Miami, FL
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New Orleans, LA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-5121
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Palo Alto, California 94304
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Phoenix, Arizona
Phone: 480-342-6641
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Richmond, Virginia 23249
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Richmond, VA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-3575
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94110
Phone: 415-600-1775
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Tampa, Florida
Phone: 813-745-5448
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Westwood, Kansas 66205
Phone: 913-588-1886
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Westwood, KS
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