This phase 1 trial is examining the effectiveness of personalized tumor antigens (PTA) in the treatment of different advanced tumors. The main outcomes to be measured will be side effects and disease control. This study is being conducted in Arizona, California, Louisiana and New Jersey, US.
While the tumor cells are growing, mutations (permanent change) in these cells can happen. This usually gives the tumor an advantage such as faster growing.
These mutations are often specific for each patient and can be detected from the outside of the cell through PTA. If PTA is given to the patients through a vaccine (ADXS-NEO) this will activate the immune system. This will detect the tumor PTA and kill the tumor cells. As PTAs are only present in tumor cells, healthy cells are not affected. This may be a safer treatment than many of the ones currently used. However, the best dosing and the associated side effects are still not clear.
This trial is examining the effectiveness of ADXS-NEO for the treatment of advanced tumors. The main outcomes to be measured will be side effects and disease control.
Who are they looking for?
This study is recruiting 48 participants. Patients must have metastatic (spread to other parts of the body) colorectal cancer and other advanced tumors that have progressed after previous treatment. Patients must have adequate organ function, no other severe disease and all toxicities from previous therapy resolved. Female patients must not be pregnant or breastfeeding and all patients able to conceive must agree to use effective birth control.
Participants must not have brain metastasis, immune disease or any other condition that could put the patient at risk. Patients must not have had other tumors within the last 2 years (unless there is a low-risk o recurrence). They must also not have heart disease, mental disease, active infection, HIV, allergy to the drug in the study, prosthetic devices. Patients must not have had major surgery within 6 weeks before this trial. Must not have received a vaccine within 30 days before this trial, treatment with immunosuppressants or treatment with antibodies or biological therapy. Must not have a life expectancy of fewer than 6 months.
How will it work
The study will be performed in 2 phases. In the first phase, patients will receive ADXS-NEO with and without pembrolizumab (Keytruda) and treatment toxicity will be studied. In the second phase, patients will receive increasing doses of ADXS-NEO and pembrolizumab to assess the best treatment dose.
Patients will be followed up for up to 5 years for side effects and tumor response.