This trial is examining the effectiveness and safety of 6MPH, a melanoma vaccine with adjuvants and a CDX-1127 monoclonal antibody in patients with melanoma. The main outcomes to be measured will be side effects and the response of the immune system. This trial is recruiting in Virginia, United States.
The details
A treatment option for patients with melanoma (a type of cancer which affects the cells in the skin) is with monoclonal antibodies (antibodies made in a laboratory which kill immune cells attached to cancer cells).
It is not known if the 6MHP vaccine given with adjuvants (montanide ISA-51, polyICLC, cyclophosphamide) and the CDX-1127 is safe and whether these adjuvants and the CDX-1127 will boost the effectiveness of the vaccine.
This study is being done to investigate the effectiveness and safety of a 6MPH vaccine with adjuvants and a CDX-1127 monoclonal antibody in patients with melanoma. The main outcome to be measured will be side effects 30 days after receiving the last dose of the vaccine.
Who are they looking for?
50 participants with melanoma will be recruited. Patients must have stage II-IV melanoma and must have adequate organ function.
Patients cannot participate if they have had chemotherapy or radiotherapy within 4 weeks of starting and must not have any allergies to the study drugs or previous vaccination with 6MHP. Participants must not be pregnant or breastfeeding. They cannot be HIV or hepatitis C positive. Patients with heart failure, uncontrolled diabetes, autoimmune conditions or substance abuse cannot participate.
How will it work
There will be two groups. Group 1 will receive 6MHP, CDX-1127 and the adjuvants. Group 2 will receive 6MHP and the adjuvants. The treatment will be given for 5 cycles. Each cycle will begin on days -6, 8, 22, 36 and 50. Patients will be followed up for 183 days.
