Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (VITILIMEL)
Primary Purpose
Melanoma and Vitiligo
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biospecimen into patients who had skin diseases
Sponsored by
About this trial
This is an interventional basic science trial for Melanoma and Vitiligo
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Skin deseases biospecimens collection
Arm Description
Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
Outcomes
Primary Outcome Measures
Changes in blood ITGBL1 expression during immunotherpay
ITGBL1 expression will be measured from the plasma of patients and compared immunotherpy response based on scanner analysis according to RECIST1.1 criteria, and compared to ITGBL1 expression in vitiligo patients or healthy controls
Secondary Outcome Measures
Changes in cytokine CXCL9 expression in plasma
Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls
Changes in cytokine CXCL10 expression in plasma
Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls
Immune cells activity
Immune cells will be isolated from the blood of all subjects and lytic activity against tumor cells will be assessed and compared to immune system activity response from the same patients
Full Information
NCT ID
NCT04920162
First Posted
June 4, 2021
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04920162
Brief Title
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma
Acronym
VITILIMEL
Official Title
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (Vitilimel Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
June 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 of response against cancer cells. Indeed, both melanoma and vitiligo are pathologies where the immune system plays an important role in the progression of the disease.
Advanced stage melanoma (metastatic lymph node and / or visceral) have a poor prognosis. Although targeted therapies and immunotherapies have improved the outcome for patient however significant proportion of these patients (~ 50%) developed resistance to therapies.
Vitiligo is a relatively common dermatosis affecting approximately 0.5% to 1% of the French population. Vitiligo results from the destruction of the melanocytes by the immune system. It is manifested by acquired depigmented macules, well limited and asymptomatic. Patients suffering from this condition have a marked decrease in their quality of life. There has been shown a strong link between vitiligo and melanoma. Indeed, patients with melanoma who develop vitiligo (~ 9% of patients treated with anti-PD-1 drugs) have a better prognosis compared to patients who do not develop vitiligo.
Interestingly, in melanoma cases where the immune system is inactive, the investigators have identified a new molecule secreted by melanoma cells, ITGBL1, leading to the exclusion of immune cells, decreased cytokines secretion and decreased immune cell activation. It is therefore essential to better understand the regulatory mechanism of the immune system in patients with vitiligo or in patients with melanoma treated by immunotherapy in order to be able to propose new therapeutic solutions for these patients.
No study to date has investigated the expression of ITGBL1 and serum inflammatory markers during the development of melanoma. Likewise in vitiligo, if a loss of ITGBL1 is observed, new treatments could be developed in order to limit the progression of the disease by re-expressing this protein.
Thus, the investigators exploratory study will provide the first answers to the predictive value of these markers for these pathologies in order to adapt and develop new treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma and Vitiligo
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skin deseases biospecimens collection
Arm Type
Other
Arm Description
Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
Intervention Type
Other
Intervention Name(s)
Biospecimen into patients who had skin diseases
Intervention Description
Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
Primary Outcome Measure Information:
Title
Changes in blood ITGBL1 expression during immunotherpay
Description
ITGBL1 expression will be measured from the plasma of patients and compared immunotherpy response based on scanner analysis according to RECIST1.1 criteria, and compared to ITGBL1 expression in vitiligo patients or healthy controls
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in cytokine CXCL9 expression in plasma
Description
Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls
Time Frame
12 months
Title
Changes in cytokine CXCL10 expression in plasma
Description
Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls
Time Frame
12 months
Title
Immune cells activity
Description
Immune cells will be isolated from the blood of all subjects and lytic activity against tumor cells will be assessed and compared to immune system activity response from the same patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henri Montaudie
Phone
0492036226
Ext
+33
Email
montaudie.h@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri Montaudie
Phone
0492036226
Email
montaudie.h@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Henri MONTAUDIE, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma
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