This trial is examining the effectiveness and toxicity of PolyPEPI1018 vaccine in the treatment of advanced colorectal cancer. The main outcome to be measured is tumor response to the treatment. This trial will be conducted in Italy, and Minnesota, US.
The standard treatment for metastatic (spread to other parts of the body) colorectal cancer is surgery, chemotherapy and radiation therapy. However, for advanced disease chemotherapy is only of limited effectiveness. The addition of biological therapy such as the PolyPEPI1018 vaccine to the treatment might improve the treatment outcomes.
This trial is examining the safety and effectiveness of the PolyPEPI1018 vaccine in the treatment of advanced colorectal cancer/ The main outcome will be the tumor response (shrinkage) to the treatment measured through a CT scan.
Who are they looking for?
This trial is recruiting 15 patients with advanced colorectal cancer with a life expectancy of more than 6 months and who received a first line of treatment. Patients must agree to use birth control and must have normal blood cell counts and adequate kidney and liver function tests.
Patients must not have had immune therapy within the last 6 weeks prior to the study, must not have a tumor with BRAF mutation (permanent change) and must not have any immune disease. Patients must not have any active infections, any other severe disease or have an allergy to the drugs in the trial. Patients who have had a major surgery or radiation therapy within 12 weeks prior to the trial or have received treatment with a vaccine within 4 weeks prior to the trial are not eligible. Patients must not have unresolved side effects from previous therapies, they should not have serious unhealed wounds or bone fractures. Female patients must not be pregnant or breastfeeding. Patients with substance abuse including alcohol, psychiatric conditions or bleeding disorders cannot participate.
How will it work
In the first part of the study, patients will receive a single vaccine dose during a 12-week follow-up. Screening will be performed at the same time as completion of standard first-line treatment and the start of the standard maintenance treatment. A single dose of the vaccine will be given after the patients start the maintenance treatment. Participants will be followed-up every 3 weeks for 12 weeks.
In the second part of the study, patients will receive 3 vaccine doses (at weeks 0, 13 and 26) and will be followed-up for 12 weeks.
The main outcomes will be the tumor response to the treatment that will be measured through CT scans.