Melanoma MetastaticNEOMELNCT06586593
Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)
An observational study of Melanoma Metastatic, run by Centre Hospitalier Universitaire de Besancon at 9 sites in France.
Trial summary
This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma. The complete histological response will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic
- How many people
- 77 participants
- Where
- 9 sitesFrance
- Study dates
- 24 Mar 2023to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)
Who may be able to join
- Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer [AJCC] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient\'s refusal to be operated.
- Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed
Who cannot join
- Uveal melanoma
Trial locations and contacts
9 sites in 1 country.
Charlée NARDIN, MD PhD contact
9 sites in 1 country
France9 sites, 1 recruiting
- Active, not recruiting
CHU Angers
Angers
- Recruiting
CHU de Besançon
Besançon
Charlée NARDIN, MD PhD, cnardin@chu-besancon.fr
CHarlée NARDIN, MD PhD
- Active, not recruiting
Hôpital Avicenne
Bobigny
- Active, not recruiting
CH de Boulogne-sur-Mer
Boulogne-sur-Mer
- Active, not recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
- Active, not recruiting
Centre de Lutte Contre le Cancer Léon Bérard
Lyon
- Active, not recruiting
ICO René Gauducheau
Saint-Herblain
- Active, not recruiting
Institut Universitaire de Cancérologie de Toulouse
Toulouse
- Active, not recruiting
CH de Valence
Valence
About this study
Official title: ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)
This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.
The complete histological response will be assessed.
- Conditions
- Melanoma Metastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Operable metastatic melanoma | Operable metastatic melanoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histological response
Histological response rate on histological analysis of the resected specimen
Measured: Day 1
Secondary outcomes (7)
Objectival response rate
Objectival response rate on imaging
Measured: Day 1
Event-free survival
An event is defined by progression of the disease or toxicity making surgery impossible, the impossibility of starting adjuvant treatment within 84 days following surgery, recurrence of melanoma after surgery or death.
Measured: Month 12
Disease Free Survival after surgery
Measured: Month 12
Overall survival
Measured: Month 18
Metastases-free survival
Measured: Month 18
Frequency of toxicities
According to Common Terminology Criteria for Adverse Events (CTCAE) v5, grades III and IV
Measured: Month 12
Severity of toxicities
According to CTCAE v5, grades III and IV
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma MetastaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586593
- Sponsor's protocol ID
- 2023/758
- Acronym
- NEOMEL
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)
- ClinicalTrials.gov ID
- NCT06586593
- Acronym / sponsor ID
- NEOMEL / 2023/758
- Conditions
- Melanoma Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.
The complete histological response will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operable metastatic melanoma | – | –Operable metastatic melanoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)
Key inclusion criteria (2 listed)
- Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer [AJCC] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient\'s refusal to be operated.
- Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed
Key exclusion criteria (1 listed)
- Uveal melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete histological response
Time frame: Day 1
Histological response rate on histological analysis of the resected specimen
7 secondary outcomes
Objectival response rate
Time frame: Day 1
Event-free survival
Time frame: Month 12
Disease Free Survival after surgery
Time frame: Month 12
Overall survival
Time frame: Month 18
Metastases-free survival
Time frame: Month 18
Frequency of toxicities
Time frame: Month 12
Severity of toxicities
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Charlée NARDIN, MD PhD contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Metastatic, run by Centre Hospitalier Universitaire de Besancon at 9 sites 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlée NARDIN, MD PhD (cnardin@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete histological response (time frame: Day 1). 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 19 Sep 2024.