Phase II Study of Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in Patients With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers
Abstract
Background:
A most common liver cancer in adults is hepatocellular carcinoma. Other kinds of liver cancer happen when colorectal or pancreatic cancer spreads to the liver. Researchers want to study if a combination of drugs helps people with these cancers. The drugs are nivolumab, tadalafil, and vancomycin.
Objective:
To investigate if nivolumab given with tadalafil and vancomycin causes liver cancer to shrink.
Eligibility:
Adults ages 18 years and older with hepatocellular carcinoma or metastases to the liver from colorectal or pancreatic cancer for which standard treatment has not worked
Design:
Participants will be screened with:
Medical and cancer history
Review of symptoms and ability to perform normal activities
Physical exam
Heart test. Some participants may meet with a cardiologist and/or have another heart test.
Scan of the chest, abdomen, and pelvis
Blood and urine tests
Tumor sample review. This can be from a previous procedure.
Participants will receive the study drugs in 4-week cycles. In each cycle participants will:
Get nivolumab through a small plastic tube in the arm on Day 1.
Take tadalafil by mouth 1 time every day.
Take vancomycin by mouth 4 times a day. They will take it every day for weeks 1 3, then not take it for week 4.
Complete a medicine diary of dates, times, missed doses and symptoms.
Throughout the study, participants will repeat screening tests and will give stool samples or rectal swabs.
After their last cycle, participants will have 3…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 22 participants or records.
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