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Clinical Trials in the UK / NCT03383458
Active, not recruiting Phase 3

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

NCT03383458 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2018-04-18
Last updated
2026-07-31

Condition(s) studied

Hepatocellular CarcinomaLiver Cancer

Investigational drug(s) / intervention(s)

NivolumabPlacebo

Nivolumab: Specified dose on specified days

Placebo: specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 * 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

Primary outcome measure(s)

Trial sites (184)

FacilityCityRegionStatus
Local Institution - 0081 Anniston Alabama
Mayo Clinic in Arizona - Phoenix Phoenix Arizona
Arizona Oncology Associates, PC - HOPE Tucson Arizona
Local Institution - 0135 Los Angeles California
Local Institution - 0088 Palo Alto California
Local Institution - 0085 San Francisco California
Local Institution - 0235 Aurora Colorado
Local Institution - 0267 Miami Florida
Sylvester Comprehensive Cancer Center/ UMHC Miami Florida
Local Institution - 0163 Tampa Florida
Local Institution - 0009 Atlanta Georgia
Local Institution - 0025 Westwood Kansas
Local Institution - 0086 New Orleans Louisiana
University of Michigan Ann Arbor Michigan
Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
Local Institution - 0209 St Louis Missouri
Local Institution - 0075 New York New York
Local Institution - 0208 New York New York
Local Institution - 0045 New York New York
Local Institution - 0219 White Plains New York
MetroHealth Medical Center Cleveland Ohio
Local Institution - 0206 Portland Oregon
Local Institution - 0272 Austin Texas
Local Institution - 0270 Dallas Texas
Local Institution - 0156 Dallas Texas
Local Institution - 0273 Tyler Texas
McGuire VA Medical Center Richmond Virginia
Local Institution - 0154 Seattle Washington
Local Institution - 0243 Gorriti Buenos Aires
Local Institution - 0254 Pilar Buenos Aires
Local Institution - 0244 Rosario Santa Fe Province
Local Institution - 0239 Blacktown New South Wales
Local Institution - 0166 Camperdown New South Wales
Local Institution - 0141 Concord New South Wales
Local Institution - 0220 Herston Queensland
Local Institution - 0164 Adelaide South Australia
Local Institution - 0224 Heidelberg Victoria
Local Institution - 0124 Nedlands Western Australia
Local Institution - 0012 Graz Austria
Local Institution - 0003 Vienna Austria

+ 144 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More Bristol-Myers Squibb trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03383458 on ClinicalTrials.gov ↗ ← All trials in the UK