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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma, Liver Cancer

In brief

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

Key facts

Study ID

NCT03383458

Run by

Bristol-Myers Squibb

People needed

545

Starts

2018-04-18

Expected to finish

2031-05-27

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]).
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• Local Institution - 0135 — Los Angeles, California, United States
• Local Institution - 0088 — Palo Alto, California, United States
• Local Institution - 0085 — San Francisco, California, United States
• Local Institution - 0235 — Aurora, Colorado, United States
• Local Institution - 0267 — Miami, Florida, United States
• Sylvester Comprehensive Cancer Center/ UMHC — Miami, Florida, United States
• Local Institution - 0163 — Tampa, Florida, United States
• Local Institution - 0009 — Atlanta, Georgia, United States
• Local Institution - 0025 — Westwood, Kansas, United States
• Local Institution - 0086 — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States
• Local Institution - 0209 — St Louis, Missouri, United States
• Local Institution - 0075 — New York, New York, United States
• Local Institution - 0208 — New York, New York, United States
• Local Institution - 0045 — New York, New York, United States
• Local Institution - 0219 — White Plains, New York, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Local Institution - 0206 — Portland, Oregon, United States
• Local Institution - 0272 — Austin, Texas, United States
• Local Institution - 0270 — Dallas, Texas, United States
• Local Institution - 0156 — Dallas, Texas, United States
• Local Institution - 0081 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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