Injections IntralesionalNCT07046728
Efficay and Safety of DAROMUN on Patient Treated by Intralesionnal Injection: DAROMEL
An observational study of Injections Intralesional, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injections Intralesional
- What is being tested?
- Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMEL
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- Patient with uveal or mucosal melanoma.
- Opposition to data use (withdrawal of non-opposition).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu de Nice
Nice, Alpes Maritimes, 06000
Emmanuelle Pradelli, 04 92 03 66 67 ext. +33, pradelli.e@chu-nice.fr
Alexandra PICARD-GAUCI, 04 92 03 67 31 ext. +33, picard-gauci.a@chu-nice.fr
About this study
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
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
- Being tested
- Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMELOther
Observationnal study with clincal data collection to evaluate the efficiency and the tolerability of DAROMUN
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors )
Objective response rate according to RECIST 1 ( Evaluation Criteria In Solid Tumors )
Measured: From baseline to 13 months ( september 1, 2024 to october 31, 2025)
Secondary outcomes (2)
Pathological complete response rate (macroscopic)
Disappearance of the disease at the macroscopic levels
Measured: From baseline to 13 months ( september 1, 2024 to october 31, 2025)
Pathological complete response rate (microscopic)
Disappearance of the disease at the microscopic levels
Measured: From baseline to 13 months ( september 1, 2024 to october 31, 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injections IntralesionalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046728
- Sponsor's protocol ID
- 25Dermato01
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07046728
- Acronym / sponsor ID
- 25Dermato01
- Conditions
- Injections Intralesional
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient with uveal or mucosal melanoma.
- Opposition to data use (withdrawal of non-opposition).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficay and Safety of DAROMUN on patient treated by intralesionnal injection: DAROMELObservationnal study with clincal data collection to evaluate the efficiency and the tolerability of DAROMUN | Other | – |
Primary outcome
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 )
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injections Intralesional, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra PICARD-GAUCI (04 92 03 67 31 ext. +33, picard-gauci.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.