Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bristol-Myers Squibb

Collaborator: Ono Pharmaceutical Co. Ltd

Stanford Investigator(s):

Intervention(s):

  • Biological: Nivolumab
  • Other: Placebo

Phase:

Phase 3

Eligibility


For more information regarding Bristol Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

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 could apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Flordeliza Mendoza
650-724-2056
Not Recruiting