This phase 1/2 trial aims to test the safety and effectiveness of a combined treatment with the new vaccine LPV7 and TLR agonists in advanced melanoma patients after surgery. The main outcome to be measured will be the treatment toxicity and response of the tumors to the treatment. This trial is recruiting in Houston, Texas and Charlottesville, Virginia in the United States.
The details
LPV7 is a new vaccine that stimulates the immune system to attack and kill melanoma cells. TLR agonists are also treatments that activate the immune system against cancer cells. It is not clear whether they are safe and effective when used in combination.
The current trial will examine combination treatment with LPV7 and different TLR agonists following surgery in patients with advanced melanoma. The main outcomes to be measured will include the change in number of immune cells, tumor responses to the combination and treatment toxicity.
Who are they looking for?
This trial will recruit 58 participants with stage 2b, 3 or 4 melanoma who have undergone surgery. Participants must not have more than 3 treated brain metastasis and must have normal blood levels. Participants must not have uveal or ocular melanoma, must not be currently receiving other treatment, and must not have any allergy to the vaccine components. Participants must not have HIV, hepatitis C, autoimmune disease or heart disease.
How will it work
Patients will be randomly assigned to one of 7 groups. All patients will be injected with vaccine LPV7 and tetanus peptide on days 1, 8, 15, 36, 57, and 78. Patients in each group will also be treated with the TLR agonists IFA, polyCLC, or resiquimod, or some combination of the three.
Resiquimod will be applied to the vaccine site immediately after injection.
The change in immune-related overall response rate will be determined following the last treatment based on levels of certain white blood cells. Side effects will be reported.
