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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Injections Intralesional
• Intervention / Treatment: Other: Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMEL

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Alexandra PICARD-GAUCI; Phone Number: +33 04 92 03 67 31; Email: picard-gauci.a@chu-nice.fr
• Study Contact Backup: Name: Emmanuelle Pradelli; Phone Number: +33 04 92 03 66 67; Email: pradelli.e@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • CHU de Nice
      • Contact: Alexandra PICARD-GAUCI; Phone Number: +33 04 92 03 67 31; Email: picard-gauci.a@chu-nice.fr
      • Contact: Emmanuelle Pradelli; Phone Number: +33 04 92 03 66 67; Email: pradelli.e@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors )	Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors )	From baseline to 13 months ( september 1, 2024 to october 31, 2025)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response rate (macroscopic)	Disappearance of the disease at the macroscopic levels	From baseline to 13 months ( september 1, 2024 to october 31, 2025)
Pathological complete response rate (microscopic)	Disappearance of the disease at the microscopic levels	From baseline to 13 months ( september 1, 2024 to october 31, 2025)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Estimated): July 1, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25Dermato01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No