This phase 2 trial will investigate the safety of pembrolizumab (Keytruda) in combination with VRP-HER2 vaccination in HER2-positive breast cancer (BC).
The main outcomes will be the response of the immune system, clinical response, and side effects. This trial will be taking place in North Carolina, the U.S.
The details
Breast cancer (BC) is one of the most common cancer types. HER2-positive (HER2+) BC is a type of cancer that does not respond to most drugs.VRP-HER2 vaccination is a new treatment for HER2+ BC. It stimulates the immune system to attack and kill HER2+ cancer cells. Immune checkpoint inhibitors (ICIs) are another new type of cancer drugs. They allow the immune system to detect and kill cancer cells. Pembrolizumab (PEM) is an ICI. It is important to understand if ICIs are safe in combination with other BC treatments.
This trial will investigate the safety of PEM in combination with VRP-HER2 in BC The main outcome will be the response of the immune system to the treatment.
Who are they looking for?
This trial will recruit 39 participants with HER2-positive BC. Patients must have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) for at least 3 weeks before the trial. Patients must have normal organ function and should not have any residual side effects from previous treatments. All patients must use highly effective methods of contraception during the trial and must be willing to provide tissue samples of the tumor.
Patients cannot take part in the trial if they have hormone-positive BC. Participants cannot undergo any other BC therapy including chemotherapy and radiation during the trial. Other exclusion criteria include brain metastases (tumors), immunodeficiency, active infections, auto-immune conditions, recent vaccination, sensitivity to PD-1 inhibitors. Patients must not be pregnant or breastfeeding and must not have any psychiatric conditions.
How will it work
A small number of participants will receive VRP-HER2 vaccination and PEM. If treatment is well tolerated then all other patients will be randomized into 3 groups. All patients will undergo a biopsy of their tumor. A blood sample will also be taken for immune cell analysis. Group A will receive VRP-HER2 vaccination. Group B will receive PEM. Group C will receive VRP-HER2 vaccination and PEM. VRP-HER2 vaccine is administered once every 2 weeks by injection. 3 doses are given. PEM is administered every 3 weeks. 5 doses are given. The study will last 24 months.
The main outcome will be the response of the immune system to the treatment. Patients will be followed up for up to 36 months for side effects and clinical response.
