Status:
COMPLETED
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Melanoma and Vitiligo
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Skin diseases can have various origins. However, a number of them are linked to an imbalance in the immune system which will lead to either an excessively strong autoimmune response or a complete lack...
Eligibility Criteria
Inclusion
- Patient diagnosed with non-segmental vitiligo (vitiligo)
- Vitiligo affecting more than 5% of the total body surface (vitiligo)
- Patient with unresectable stage III or stage IV skin melanoma confirmed histologically (melanoma)
- Treatment-naïve patient with an indication for anti-PD1 mono-immunotherapy with nivolumab or pembrolizumab regardless of their BRAF status (melanoma)
Exclusion
- Segmental or mixed vitiligo (vitiligo)
- Photodermatosis or taking a photosensitizing treatment (vitiligo)
- Patient being allergic to gluten (vitiligo)
- Melanoma of unknown origin (melanoma)
- Ocular melanoma or mucous melanoma (melanoma)
- Patient with brain metastases, symptomatic or not (melanoma)
- Disease not measurable according to RECIST 1.1 criteria (melanoma)
- Patient for whom a combination of anti-PD1 and anti-CTLA-4 immunotherapy is being considered. (melanoma)
- Active autoimmune disease: chronic inflammatory bowel disease and patients with autoimmune disease that is or has been symptomatic
- Patients with autoimmune motor neuropathy
- Concomitant intake of oral immunosuppressive therapy or topical corticosteroid therapy (on vitiligo lesions) or systemic
- Organ transplant patients (kidney, liver, lung, heart, etc.)
- Patient with a history of clinically significant allergy
- History of treatment with anti-CTLA-4, anti-PD-1 or anti-PD-L1, including in an adjuvant situation
- HIV and / or HCV and / or HBV positive serologies
- Patient's refusal to do an HIV, HBV, HCV serology
- Vulnerable people (minors, patients under guardianship or guardianship, deprived of their liberty, under the protection of justice, etc.)
- Patient participating or having participated in another clinical drug trial during the month preceding inclusion
- Women who are pregnant or breastfeeding or who planned to become pregnant during the course of the study.
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04920162
Start Date
December 28 2021
End Date
April 5 2024
Last Update
November 22 2024
Active Locations (1)
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1
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, France, 06000