Menu
Not yet recruiting NCT07046728

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

— Observational Injections Intralesional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMEL.
Who it may be relevant to
Registry conditions: Injections Intralesional. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors ) [Time frame: From baseline to 13 months ( september 1, 2024 to october 31, 2025)]
Secondary outcome measures (2)
  • Pathological complete response rate (macroscopic) [Time frame: From baseline to 13 months ( september 1, 2024 to october 31, 2025)]
  • Pathological complete response rate (microscopic) [Time frame: From baseline to 13 months ( september 1, 2024 to october 31, 2025)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chu de Nice — Nice

Identifiers

NCT: NCT07046728 · 25Dermato01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗