This phase 2 study will investigate Tavokinogene Telseplasmid Electroporation (TTE) in combination with pembrolizumab (Keytruda) in advanced or not suitable for surgery triple-negative breast cancer (TNBC).
The main outcome will be the objective response rate (ORR). This trial is recruiting in the United States and Australia.
Breast cancer (BC) is one of the most common cancer types. There are many subtypes of BC. BC subtypes are based on a number of factors. Triple negative BC (TNBC) is an aggressive form of BC. TNBC cells do not express the three most common factors linked to BC. These are estrogen and progesterone receptors, and the HER-2 gene. There are fewer treatment options for TNBC. Tavokinogene Telseplasmid Electroporation (TTE) is a targeted cancer treatment. It delivers the interleukin-12 (Il-12) gene into the tumor. This increases the immune response to the tumor and kills tumor cells. TTE is an experimental treatment. Pembrolizumab (PBZ) is an FDA-approved drug. It is an immune-checkpoint inhibitor (ICI). ICIs allow immune cells to recognize and kill cancer cells.
This study will investigate the safety and effectiveness of TTE in combination with PBZ in TNBC. The main outcome will be the ORR.
Who are they looking for?
This trial will recruit 25 patients with advanced or inoperable TNBC. Patients must have received previously at least one approved treatment.Participants must have a life expectancy of at least 6 months and adequate organ function. Participants must use a reliable method of contraception to prevent pregnancy.
Patients cannot take part in the trial if they have a different progressive cancer. Patients with active brain tumors are excluded from the trial. A history of active infection, immune disorders or patients taking drugs to suppress the immune system are excluded. Other exclusion criteria include a history of organ transplant, lung infections, interstitial lung disease, psychiatric illness or recent (live) vaccination. Female patients must not be pregnant or breastfeeding.
How will it work
All patients will be treated with TTE and PBZ. TTE is a minimally-invasive procedure. A needle is inserted into the tumor. An electric pulse is administered. This delivers the Il-12 gene to the cells. This procedure is repeated every 6 weeks. PBZ is administered intravenously once every 3 weeks. Treatment will last up to 2 years.