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

June 23, 2025 updated by: Centre Hospitalier Universitaire de Nice

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pathological complete response rate (macroscopic)
Time Frame: From baseline to 13 months ( september 1, 2024 to october 31, 2025)
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)
Time Frame: From baseline to 13 months ( september 1, 2024 to october 31, 2025)
Disappearance of the disease at the microscopic levels
From baseline to 13 months ( september 1, 2024 to october 31, 2025)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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