Injections Intralesional
Conditions
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.
Interventions
OTHEREfficay 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
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors ) | From baseline to 13 months ( september 1, 2024 to october 31, 2025) | Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response rate (macroscopic) | From baseline to 13 months ( september 1, 2024 to october 31, 2025) | Disappearance of the disease at the macroscopic levels |
| Pathological complete response rate (microscopic) | From baseline to 13 months ( september 1, 2024 to october 31, 2025) | Disappearance of the disease at the microscopic levels |
Countries
France
Contacts
Primary ContactAlexandra PICARD-GAUCI
Backup ContactEmmanuelle Pradelli
Outcome results
None listed