This trial aims to find out if a new vaccine called NEO-PV-01 is safe to use in the treatment of advanced melanoma in combination with ipilimumab (Yervoy) or APX005M and with nivolumab (Opdivo). The main outcomes that will be measured will be side effects and response to treatment. The study is being conducted in the United States.
The details
There are a number of treatments available for melanoma. NEO-PV-01 is a personalised anti-cancer vaccine. It is made to specifically include targets for the immune system that are present uniquely on the patient's tumor. APX005M, ipilimumab, and nivolumab are targeted therapies that act on the immune system to fight cancer.
This trial aims to find out if NEO-PV-01 is safe to use in the treatment of advanced melanoma in combination with ipilimumab or APX005M, and with nivolumab. The main outcome that will be measured is the rate of side effects and response to treatment.
Who are they looking for?
40 participants with advanced melanoma are needed. Patients must have adequate blood cell counts and liver and kidney function tests and must have recovered from the side effects of previous cancer treatments. Female patients must not be pregnant or planning to get pregnant. Patients must agree to use contraception during the study and 120 days after the last dose.
Patients cannot have received treatment for metastatic cancer before. Patients cannot have any autoimmune diseases, HIV, or infections. They cannot have received a live vaccine in the previous month and cannot be on another clinical trial.
How will it work
Patients included in this study may receive any combination of the following treatments. Treatment with ipilimumab, nivolumab, chemotherapy, APX005M, or the vaccine NEO-PV-01. All patients will receive nivolumab. Patients will be followed-up for 52 weeks for response rate and side effects.
