Understanding tumor metabolism in melanoma and immunotherapy resistance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how changes in tumor metabolism contribute to resistance against immunotherapy in melanoma patients. By analyzing tumor cells from patients who are either sensitive or resistant to treatments like anti-PD1, the research aims to identify metabolic alterations that could inform new therapeutic strategies. The approach involves biopsying melanoma cells from patients with advanced stages of the disease who are about to start immunotherapy. The findings could lead to more effective treatments that target tumor cells while preserving the immune response.

Why it matters

Who can join: the full rules

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's running

• CHU de Nice
  Nice, Alpes-maritimes, France Recruiting

Study contacts

• Principal investigator: Montaudie Henri — CHU de Nice, Service de Dermatologie
• Study coordinator: Montaudie Henri
• Email: montaudie.h@chu-nice.fr
• Phone: +33492036488

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.