This trial is examining the effectiveness of a new medication for treating melanoma called Daromun, given before surgery. The main outcome to be measured will be survival without cancer. This study is being conducted in Tampa, Florida, the United States.
The details
Surgery is one of the main treatments for melanoma. After surgery, immunotherapy or targeted therapy may be given to prevent cancer from coming back. Daromun is a new immunotherapy being developed for treating melanoma. It is a combination of two medications called Darleukin and Fibromun. It is injected directly into the tumor before surgery. It works by turning on the immune system to kill the cells in the tumor.
The study is trying to find out if using Daromun before surgery makes it less likely for cancer to come back. The main outcome to be measured is survival time without any signs of cancer.
Who are they looking for?
248 participants with stage III melanoma are needed for this study. Patients must be eligible for surgery on all tumors. Tumors must be able to be injected with medication. Patients must not have HIV and hepatitis B/C. They also must have normal blood cell counts and normal liver function tests. Patients must meet certain blood test requirements. Patients of childbearing age must agree to use contraception during the study and up to 3 months after the study. Female patients must not be pregnant or breastfeeding.
Patients with distant metastases (cancer spread to distant parts of the body) or with present or previous other cancer will be excluded. Participants must not have any severe heart problems, diabetic eye disease, active autoimmune conditions or a history of organ or stem cell transplantation. Patients taking corticosteroids, immunotherapy or other anti-cancer treatments within 4 weeks of the study will not be recruited.
How will it work
Participants will be randomly assigned to one of two groups. One group will recieve injections of Daromun into the tumor, followed by surgery to remove the tumor. The other group will just receive the surgery. Daromun injections will be given once a week for up to 4 weeks.
The patients will be followed up for up to five years after the surgery to see if or when cancer comes back. Side effects will also be evaluated.
