About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Biposy
Other interventionBiopsy at inclusion visit and at disease progression if applicable
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline pyrimidine metabolism at 4 years
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
Secondary outcomes
Overall Survival
Overall survival (OS) will be measured using the Kaplan-Meier method
Sponsors and contacts
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