For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
  2. Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
  3. Child-Pugh Score 5 or 6
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  2. Any evidence of tumor metastasis or co-existing malignant disease
  3. Participants previously receiving any prior therapy for HCC, including loco-regional therapies
  4. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
  5. 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


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Hepatocellular Carcinoma,Liver Cancer

Age (in years)

18+

Phase

Phase 3

Participants needed

545

Est. Completion Date

Dec 16, 2025

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT03383458

Study number

CA2099DX

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