Recruiting
Not applicable
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Condition(s) studied
Melanoma (Skin)
Investigational drug(s) / intervention(s)
Biposy
Biposy: Biopsy at inclusion visit and at disease progression if applicable
Study 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 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).
Eligibility
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.
Primary outcome measure(s)
- Change from baseline pyrimidine metabolism at 4 years — At inclusion visit and 4 years
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
Trial sites (1)
| Facility | City | Region | Status |
| CHU de Nice |
Nice |
Alpes-maritimes |
Recruiting |
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