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Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05307289
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Hospitalier Universitaire de Nice
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Montaudie Henri
Principal Investigator Affiliation CHU de Nice, Service de Dermatologie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Melanoma (Skin)
Arms & Interventions

Arms

Other: melanoma inclusion

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.

Interventions

Other: - Biposy

Biopsy at inclusion visit and at disease progression if applicable

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Nice, Nice, Alpes-maritimes, France

Status

Recruiting

Address

CHU de Nice

Nice, Alpes-maritimes, 06001

Site Contact

Montaudie Henri

[email protected]

+33492036488

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