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

NCT03383458

Active Not RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Hepatocellular Carcinoma, Liver Cancer

Interventions: Nivolumab, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (184)
  • Anniston, Alabama, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Westwood, Kansas, United States
  • New Orleans, Louisiana, United States
  • Ann Arbor, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • White Plains, New York, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Tyler, Texas, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • Gorriti, Buenos Aires, Argentina
  • Pilar, Buenos Aires, Argentina
  • + 154 more on CT.gov