Daromun for Stage IIIB/C/D Melanoma
This study is looking at whether adding Daromun, given as injections into tumors, before surgery can help people with advanced melanoma (skin cancer) that has spread locally. You might be eligible if you have Stage IIIB, IIIC, or IIID melanoma that can be surgically removed. The study compares Daromun plus surgery and standard follow-up treatment to just surgery and standard follow-up treatment. Researchers want to see if Daromun helps prevent the cancer from coming back (recurrence-free survival). The study is currently unclear on its recruitment status and plans to enroll 186 participants.
- Study design
- This is an open-label, randomized study with two groups, involving 186 participants. You would be randomly assigned to one of two treatment groups.
- What's involved
- You would receive Daromun injections once a week for up to 4 weeks, followed by surgery and then standard follow-up therapy. You will be followed for up to 6 years after randomization.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for up to 6 years after you join the study to track if the cancer returns and your overall survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
At a glance
Conditions
Where it's being run
37 sites across 29 statesWho to contact
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What this trial measures
- Recurrence Free Survival (RFS)From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.
Recurrence Free Survival (RFS) in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery and adjuvant therapy control group (Arm 2). Analysis will be performed for the "Intention To Treat" population.