Efficay and Safety of DAROMUN on Patient Treated by Intralesionnal Injection: DAROMEL

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DAROMUN for people with advanced melanoma, a serious type of skin cancer that has spread to nearby areas but can still be removed by surgery. DAROMUN is given as an injection directly into the tumor and works by helping the body’s immune system fight the cancer more effectively. Researchers want to see how well this treatment works in shrinking tumors and preventing the cancer from spreading further, as well as how safe it is for patients.

The trial is designed for adults with stage IIIB to IIID melanoma who have had cancer return or progress after previous treatments like immunotherapy, or for those who cannot have immunotherapy due to other health reasons. Participants will have already received at least one injection of DAROMUN into their tumor. The study will look at how the tumors respond to the treatment, whether the cancer spreads, and overall survival rates. This research hopes to offer a new option for patients with advanced melanoma that is still operable but challenging to treat with current methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient over 18 years old with locally advanced melanoma stage IIIB, IIIC, or IIID.
• • Patient diagnosed with cutaneous melanoma or melanoma of unknown primary origin.
• • Disease progression after treatment with immunotherapy in the adjuvant or metastatic setting.
• • Patient having a contraindication to immunotherapy.
• • Patient having received at least one intralesional infusion of Daromun.
• Exclusion Criteria:
• • Patient with uveal or mucosal melanoma.
• • Opposition to data use (withdrawal of non-opposition).