Study on Nivolumab for Liver Cancer Patients at High Risk of Cancer Returning After Surgery or Ablation
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT03383458
This clinical trial is testing whether the drug nivolumab can help prevent liver cancer from coming back in patients who have had surgery or ablation to remove or destroy their cancer and are at high risk of recurrence.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out if nivolumab can help prevent liver cancer from returning in patients who have had their cancer completely removed through surgery or destroyed by ablation. The study will compare the effects of nivolumab to a placebo in patients who are at high risk of their cancer coming back.
Eligibility Criteria
Inclusion Criteria
- First-time diagnosis of liver cancer (HCC) and have had surgery or ablation to remove or destroy the cancer.
- Can participate if the liver cancer is not related to a virus, or if it is related to hepatitis B or C.
- Have a Child-Pugh Score of 5 or 6, which measures liver function.
- Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Have a specific type of liver cancer known as fibrolamellar, sarcomatoid, or mixed with bile duct cancer.
- Have any signs of cancer spreading or another type of cancer.
- Have received any previous treatment for liver cancer, including local therapies.
- Have had a liver transplant or are on the waiting list for one.
- Have received a live vaccine within 30 days before starting the study, such as vaccines for chickenpox, shingles, yellow fever, rotavirus, oral polio, or MMR.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0081 | 36207 | Anniston | Alabama |
| Mayo Clinic in Arizona - Phoenix | 85054 | Phoenix | Arizona |
| Arizona Oncology Associates, PC - HOPE | 85711 | Tucson | Arizona |
| Local Institution - 0135 | 90095 | Los Angeles | California |
| Local Institution - 0088 | 94304 | Palo Alto | California |
| Local Institution - 0085 | 94115 | San Francisco | California |
| Local Institution - 0235 | 80045 | Aurora | Colorado |
| Local Institution - 0267 | 33125 | Miami | Florida |
| Sylvester Comprehensive Cancer Center/ UMHC | 33136 | Miami | Florida |
| Local Institution - 0163 | 33612 | Tampa | Florida |
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