This trial is examining the most beneficial dose of an experimental AE37 vaccine when used with biological therapy pembrolizumab (Keytruda). The main outcomes to be measured are the maximum safest dose of AE37 and objective response rate. This study is recruiting in Illinois and West Virginia, US.
Triple-negative breast cancer (TNBC) can be challenging to treat. Additionally, breast cancer that spreads to other areas of the body, called metastatic, is more difficult to treat.
Pembrolizumab is a treatment which helps turn on the patient’s immune system to fight cancer cells. It has been successful in treating a number of cancers. AE37 is a vaccine that boosts this effect in breast cancer. It is not known how effective it is for metastatic TNBC.
This trial is examining the safety and effectiveness of the AE37 vaccine in combination with pembrolizumab in patients with advanced TNBC. The main outcome of this trial will be to evaluate the safest maximum dose of AE37 combined with pembrolizumab and response to treatment.
Who are they looking for?
This study is recruiting 29 patients with metastatic TNBC. Patients must provide a tissue sample from the tumor. Patients who received chemotherapy, radiotherapy or surgery prior to the trial should have recovered from the side effects. Patients should have adequate blood counts and good liver and kidney function. Patients of childbearing age should agree to the use of contraception until 120 days after the study ends.
Patients who received an experimental treatment, biological therapy or other drugs 4 weeks or less before the study begins cannot participate. Patients with immunodeficiencies, who are pregnant or breastfeeding cannot participate. Patients allergic to the study drugs cannot participate. Patients who received chemotherapy or radiotherapy 2 weeks before the study cannot participate. Patients with a second type of cancer or cancer in the brain and with certain infections including HIV, Hepatitis B, and C cannot participate.
How will it work
All patients will be given the AE37 vaccine every 21 days up to 5 doses in combination with pembrolizumab every 21 days for up to 2 years.
The maximum safest dose of AE37 will be measured for the 3 treatment cycles of 21 days. Cancer response to treatment, time without the cancer growing and survival of patients will be measured for up to 2 years. Side effects experienced by patients will be measured for 90 days after the trial finishes.