Melanoma (Skin)MEL-METANCT05307289
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
A study testing Biposy in people with Melanoma (Skin), run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Biposy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to 25 Oct 2028
- Phase
- Interventional
- 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
Who may be able to join
- Female or male, 18 years of age or older
- Stage III unresectable or histologically confirmed stage IV cutaneous melanoma (melanoma of unknown origin is accepted), treatment naïve (metastatic stage) and for which immunotherapy will be started
- Performance Status ≤1
- BRAF status available; BRAF status determination is required but patient will be eligible regardless of BRAF status
- For women of childbearing potential, effective contraception must be initiated during the study.
- Patient affiliated to social security plan
- Patient having signed informed consent
Who cannot join
- Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed
- Patients with ocular or mucosal melanoma of metastatic ocular melanoma
- Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).
- Contraindication to the initiation of immunotherapy: HIV and/or HCV and/or HBV positive, active autoimmune disease (chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease, vasculitis, etc.), patients with autoimmune motor neuropathy (such as Guillain Barré syndrome).
- Vulnerable patients: minors, adults under guardianship or curatorship, deprived of liberty
- Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
- A psychiatric or addiction history that will compromise the patient's ability to consent and follow the proper protocol procedures
- Any other clinical finding that, in the opinion of the principal investigator, could interfere with the results of the study or pose a risk to the patient during the study.
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, 1 recruiting
- Recruiting
CHU de Nice
Nice, Alpes-maritimes, 06001
Montaudie Henri, montaudie.h@chu-nice.fr
Montaudie Henri
About this study
Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells responsible for the anti-tumor immune response. The main objective is to evaluate metabolism modulations in melanoma cells extracted from metastases of patients sensitive and resistant to immunotherapies (anti-PD1 or anti-PD1+anti-CTLA4).
- Conditions
- Melanoma (Skin)
- Being tested
- Biposy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiposyOther
Biopsy at inclusion visit and at disease progression if applicable
| Study group | Role | What they receive |
|---|---|---|
| melanoma inclusion | Other | Biopsy of a metastasis allowing melanoma diagnosis and realization of primary cultures for metabolomics. An additional 20ml blood sample will also be taken to quantify circulating metabolites and to isolate PBMC. Receives: Other: Biposy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pyrimidine metabolism at 4 years
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
Measured: At inclusion visit and 4 years
Secondary outcomes (1)
Overall Survival
Overall survival (OS) will be measured using the Kaplan-Meier method
Measured: At inclusion visit and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start25 May 2022
- Primary completion25 May 2028 (estimated)
- Study completion25 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montaudie Henri, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307289
- Sponsor's protocol ID
- 21-PP-20
- Acronym
- MEL-META
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2022
- Last updated
- 31 Dec 2025
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
- ClinicalTrials.gov ID
- NCT05307289
- Acronym / sponsor ID
- MEL-META / 21-PP-20
- Conditions
- Melanoma (Skin)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 May 2028 (estimated)
- Study completion
- 25 Oct 2028 (estimated)
- First posted
- 1 Apr 2022 (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.
Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells responsible for the anti-tumor immune response. The main objective is to evaluate metabolism modulations in melanoma cells extracted from metastases of patients sensitive and resistant to immunotherapies (anti-PD1 or anti-PD1+anti-CTLA4).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| melanoma inclusion | Other | Other: BiposyBiopsy of a metastasis allowing melanoma diagnosis and realization of primary cultures for metabolomics. An additional 20ml blood sample will also be taken to quantify circulating metabolites and to isolate PBMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or male, 18 years of age or older
- Stage III unresectable or histologically confirmed stage IV cutaneous melanoma (melanoma of unknown origin is accepted), treatment naïve (metastatic stage) and for which immunotherapy will be started
- Performance Status ≤1
- BRAF status available; BRAF status determination is required but patient will be eligible regardless of BRAF status
- For women of childbearing potential, effective contraception must be initiated during the study.
Key exclusion criteria (8 listed)
- Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed
- Patients with ocular or mucosal melanoma of metastatic ocular melanoma
- Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).
- Contraindication to the initiation of immunotherapy: HIV and/or HCV and/or HBV positive, active autoimmune disease (chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease, vasculitis, etc.), patients with autoimmune motor neuropathy (such as Guillain Barré syndrome).
- Vulnerable patients: minors, adults under guardianship or curatorship, deprived of liberty
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 |
|---|---|---|
| BiposyBiopsy at inclusion visit and at disease progression if applicable | Other | melanoma inclusion |
Primary outcome
Change from baseline pyrimidine metabolism at 4 years
Time frame: At inclusion visit and 4 years
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
1 secondary outcome
Overall Survival
Time frame: At inclusion visit and 4 years
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 31 Dec 2025.
- 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.
Montaudie Henri principal investigator
CHU de Nice, Service de Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biposy in people with Melanoma (Skin), 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 31 Dec 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 Montaudie Henri (+33492036488, montaudie.h@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pyrimidine metabolism at 4 years (time frame: At inclusion visit and 4 years). 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 31 Dec 2025.