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Recruiting Not applicable

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

NCT05307289 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-05-25
Last updated
2025-12-31

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

Sex
ALL
Min age
18 Years
Max age
—
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.

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)

FacilityCityRegionStatus
CHU de Nice Nice Alpes-maritimes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05307289 on ClinicalTrials.gov ↗ ← All trials in France