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.

NCT03567889

Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients

Recruiting
PHASE3Ages 18+InterventionalTreatment
Philogen S.p.A.
~186 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:DaromunSurgeryAdjuvant therapy

At a glance

Recruiting sites
26 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence Free Survival (RFS)
Measured over 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.
Melanoma Stage IIIB
Melanoma Stage IIIC
Melanoma Stage IIID
37 sites across 29 states
Barcelona4
Pennsylvania3
California2
New York2
Madrid2
Arizona1
Florida1
Georgia1

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  • 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.