Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Recruiting · NCT05307289 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Nice
View the official record on ClinicalTrials.gov →Interventions studied
Biposy
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- CHU de Nice - Nice, Alpes-maritimes, France