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

NCT ID: NCT07046728

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-03-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Nice

Nice, Alpes Maritimes, France

Countries

France

Central Contacts

Alexandra PICARD-GAUCI

Role: CONTACT

picard-gauci.a@chu-nice.fr

04 92 03 67 31 ext. +33

Emmanuelle Pradelli

Role: CONTACT

pradelli.e@chu-nice.fr

04 92 03 66 67 ext. +33

Facility Contacts

Emmanuelle Pradelli

Role: primary

pradelli.e@chu-nice.fr

04 92 03 66 67 ext. +33

Alexandra PICARD-GAUCI

Role: backup

picard-gauci.a@chu-nice.fr

04 92 03 67 31 ext. +33

Other Identifiers

25Dermato01

Identifier Type: -

Identifier Source: org_study_id