Status:
RECRUITING
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 propo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05307289
Start Date
May 25 2022
End Date
October 25 2028
Last Update
December 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Nice
Nice, Alpes-maritimes, France, 06001