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NCT Number: NCT04920162

Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma

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.

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Key information

Conditions

Melanoma and Vitiligo Hypopigmentation Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pigmentation Disorders Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Vitiligo

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimen into patients who had skin diseases

Other

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 outcomes

  1. Changes in blood ITGBL1 expression during immunotherpay

    Time frame: 12 months

    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 outcomes

  1. Changes in cytokine CXCL9 expression in plasma

    Time frame: 12 months

    Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls

  2. Changes in cytokine CXCL10 expression in plasma

    Time frame: 12 months

    Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls

  3. Immune cells activity

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (Vitilimel Study)

Acronym: VITILIMEL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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