An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:September 26, 2012
End Date:December 26, 2019

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A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

The first part of the study is the Dose Escalation Phase designed to establish the safety of
nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular
carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B
virus (HBV)-infected subjects).

The second part of the study is the Expansion Phase designed to generate additional clinical
data at specified doses for each of the 3 cohorts. A third cohort has been added in this
study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A
fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus
ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data
will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added
to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and
nivolumab with ipilimumab in combination with cabozantinib.

Study Classification: Pharmacokinetics/Pharmacodynamics

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

Inclusion Criteria:

- Subjects of 18 years or older (men and women) with histologically confirmed advanced
hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or
progressive disease after surgical and /or locoregional therapies

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

- Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh
Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less

Exclusion Criteria:

- History of autoimmune disease

- Any prior or current clinically significant ascites

- Any history of hepatic encephalopathy
We found this trial at
11
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 800-865-1125
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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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-712-7485
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-9347
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Boston, MA
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-2855
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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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-5078
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Halifax, Nova Scotia
Phone: 902-473-6106
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Halifax,
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-563-7757
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-0460
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, CA
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703 Main Street
Paterson, New Jersey 07503
973.754.2000
Phone: 973-754-3811
Saint Joseph's Regional Medical Center Rich in history, St. Joseph's Healthcare System has evolved from...
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Paterson, NJ
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Pensacola, Florida 32504
Phone: 850-416-2730
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Pensacola, FL
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Washington, District of Columbia 20057
Phone: 202-687-2007
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Washington,
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