NCT07046728Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 23 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Melanoma
- NCT number
- NCT07046728
What you commit to
- Study type: Observational
- Planned participants: 70
- From 1 Jul 2025 to the primary completion date, 1 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient with uveal or mucosal melanoma.
- Opposition to data use (withdrawal of non-opposition).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.