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

  • STATUS
    Recruiting
  • End date
    Jun 14, 2025
  • participants needed
    530
  • sponsor
    Bristol-Myers Squibb
Updated on 4 November 2020
carcinoma
nivolumab
hepatocellular carcinoma

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

Details
Treatment Placebo, Nivolumab
Clinical Study IdentifierNCT03383458
SponsorBristol-Myers Squibb
Last Modified on4 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: HEPATOCELLULAR CARCINOMA or HEPATIC NEOPLASM or Malignant Adenoma or Liver Cancer or Adenocarcinoma?
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 could apply
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