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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

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

Qualifiers

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

Treatments tested in this trial

  • Biposy

Treatment groups

20 Participants
are divided into 1 treatment group