Melanoma (Skin)
Conditions
Brief 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).
Interventions
OTHERBiposy
Biopsy at inclusion visit and at disease progression if applicable
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline pyrimidine metabolism at 4 years | At inclusion visit and 4 years | Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | At inclusion visit and 4 years | Overall survival (OS) will be measured using the Kaplan-Meier method |
Countries
France
Contacts
Primary ContactMontaudie Henri
Outcome results
None listed