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NCT ID: NCT03411486 Not yet recruiting - Breast Cancer Clinical Trials

Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Priming Followed by Fowlpox Booster Vaccines Modified to Express Brachyury and T-Cell Costimulatory Molecules (MVA-BN-Brachyury/FPV-Brachyury)

Start date: February 6, 2018
Phase: Phase 1
Study type: Interventional

Background: Brachyury controls the expression of other genes in our cells. How this happens is not fully understood. Research shows that in some cancers, brachyury is over-expressed. This may play a role in cancer growth and metastasis. Researchers want to test a vaccine that turns the immune system against brachyury. The vaccine is made up of 2 viruses: Modified Vaccinia Ankara (MVA) and Fowlpox virus (FPV). The goal is to teach the immune system to kill the tumor cells that express the Brachyury protein. Objectives: To test if the booster doses of FPV-Brachyury Fowlpox are safe and can improve the immune response and make it last longer in people with advanced cancer. Eligibility: Adults 18 85 years old with cancer that has not responded to standard therapies. Design: Participants will be screened with medical history, review of their tumor sample, and physical exam. They will have blood and urine tests. They will have scans and X-rays to assess their cancer. They will have a heart test. Participants will get the vaccine in shots under the skin, close to lymph nodes. Shots will be given every 4 12 weeks for 2 years as long as participants can and are willing to continue to participate. At these visits, they will repeat some or all the screening tests, except the tumor sample review. After 2 years, participants will get phone calls every 3 months for 5 years. They will talk about any symptoms they have had.