Understanding tumor metabolism in melanoma and immunotherapy resistance
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
NA · Centre Hospitalier Universitaire de Nice · NCT05307289
This study is trying to see how changes in melanoma tumor cells affect their response to immunotherapy, hoping to find better treatment options for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Nice, Alpes-maritimes) |
| Trial ID | NCT05307289 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable stage III or confirmed stage IV cutaneous melanoma who are treatment naïve and about to begin immunotherapy.
Not a fit: Patients with ocular or mucosal melanoma, or those who have received other forms of treatment like targeted therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for melanoma patients who currently experience resistance to immunotherapy.
How similar studies have performed: While the specific metabolic mechanisms in melanoma resistance to immunotherapy are still being explored, similar studies have shown promise in understanding tumor biology and improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nice, Alpes-maritimes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma