NCT07046728

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

Observationnal Multicentric Study to Evaluate the Safety and the Efficacy of DAROMUN of Melanoma Patient (Resectable Stage IIIB to IIID) Treated by Intralesionnal Injection

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Melanoma is a malignant tumor originating from melanocytes, with a high metastatic potential, particularly in advanced stages. The standard treatment for resectable melanomas has traditionally been surgery, often followed by adjuvant therapy to reduce the risk of recurrence. However, the emergence of neoadjuvant/perioperative therapies, administered prior to surgery, has revolutionized the management of patients with stage IIIB-C-D melanoma presenting with locoregional macroscopic metastases. Another therapeutic approach involving an intratumoral immunocytokine called DAROMUN (a fusion protein combining an antibody and a cytokine), designed to stimulate antitumor immunity within the melanoma cell microenvironment, was presented at the global oncology congress (ASCO) in June 2024. Preliminary biomarker analyses indicated that treatment with DAROMUN leads to an increase in tumor-infiltrating lymphocytes, particularly CD4+ and CD8+ cells, suggesting immune activation within the tumor microenvironment. This molecule, recently made available through a compassionate use program on the website of the French National Agency for the Safety of Medicines and Health Products (ANSM), may be particularly beneficial for patients who experience recurrence despite prior adjuvant therapy and who have locally advanced, resectable melanoma.The team therefore aim to conduct a real-world, ambispective, multicenter study under the auspices of the Cutaneous Oncology Group (GCC) of the French Society of Dermatology (SFD), focusing on the use of DAROMUN in patients with stage IIIB-IIID locally advanced melanoma.The primary endpoint will be to assess the response rate to treatment according to RECIST 1.1 criteria.Secondary endpoints will include: distant metastasis-free survival, pathological complete response rate, treatment safety profile, and overall survival.

Conditions

• Injections Intralesional

Interventions

Type	Name	Description
OTHER	Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMEL	Observationnal study with clincal data collection to evaluate the efficiency and the tolerability of DAROMUN

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-01
• Completion: 2026-03-01
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: France