3 Clinical Trials for Various Conditions
Background: Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare liver cancer. It most often occurs in young people who have no history of liver disease. Unresectable FLC most often does not improve with surgery. Researchers think gut bacteria may affect liver cancer control. They want to see if a drug that controls a type of bacteria can help. Objective: To test if vancomycin is safe and tolerable for and can treat people with unresectable FLC. Eligibility: People ages 18 and older with FLC that isn t responsive to treatment Design: Participants will be screened with a medical history, physical exam, blood and urine tests, and CT or MRI scans. They will provide a tumor sample: If they do not have one, they will have a biopsy. Participants will take vancomycin 3 times a day. They will take the drug by mouth. They will take the drug in 28-day cycles. They will take the drug daily for the first 3 weeks. They will not take the drug the last week. Participants will keep a medication diary. Participants will have blood and urine tests each cycle. They may provide stool samples. Participants will have a biopsy before they start treatment. Then they will have one on day 1 of cycle 2. Participants will have scans on day 1 of cycle 2. Then they will have scans about every 8 weeks. Participants will continue treatment until their cancer gets worse or they can no longer tolerate the side effects. Participants will have a follow-up visit about a month after they finish treatment. Then they will be followed every 6 months by phone or email.
The primary objective of the trial is the safety and tolerability of administering a vaccine targeting the DNAJB1-PRKACA fusion kinase, in combination with nivolumab and ipilimumab in patients with unresectable or metastatic FLC and with non-FLC solid tumors and to assess the T-cell response.
The purpose of this study is to determine whether the combination of subcutaneous DRP-104 in combination with intravenous Durvalumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).