Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

Hospices Civils de Lyon5 enrolled

Overview

This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Metastatic Melanoma

Interventions

Blood and biopsy samplingBIOLOGICAL

Blood samples (52mL) will be taken at week 1, week 3, week 7, week 13, week 53 or at the progression. Skin biopsies will be taken at week 1, week 7, week 53 or at the progression.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women aged ≥ 18 years of age. * Patient with metastatic or unresectable melanoma * Nivolumab or Nivolumab + Ipilimumab treatment indication * Skin biopsies available * Patient affiliated to or a beneficiary of a social security category. * Signed Written Informed Consent. * Patient who agrees to the storage of his biological samples Exclusion Criteria: * Treated haematological malignancies Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Patients with autoimmune disease. * Ocular melanoma

Locations (1)

Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

Pierre-Bénite, France

Outcomes

Primary Outcomes

Change description of biological characteristics of immune cells of the blood by immunomonitoring.

Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring

Time frame: Week 1 (baseline, before the 1st injection), week 3 (before the 2d injection treatment), week 7 (before the 4th) , week 13 (before the 5th), week 53 (before the 26th or during radiological evaluation) or at the progression

Change in the immune response by skin biopsy.

Time frame: Week 1 (Baseline), week 7, week 53 or at the progression.

Secondary Outcomes

Progression-free survival

Progression free survival (PFS) will be calculated as the period of time from the immunotherapy first administration to the first RECIST 1.1 disease progression

Time frame: Week1 , every radiological assessments defined by standard care (not by specific time frame)

Overall survival

Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death.

Time frame: week 1, date of patient death

Auto-immune adverse event frequency

Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells

Time frame: baseline, week 53 or at the progression

Subtype of melanoma correlated with biological characteristics of immune cells

Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells

Time frame: baseline

Data from ClinicalTrials.gov

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