Metastatic Melanoma
Conditions
Keywords
Melanoma, Nivolumab, Ipilimumab, Immune modulation
Brief summary
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.
Interventions
BIOLOGICALBlood and biopsy sampling
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change description of biological characteristics of immune cells of the blood by immunomonitoring. | 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 | Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring |
| Change in the immune response by skin biopsy. | Week 1 (Baseline), week 7, week 53 or at the progression. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Week1 , every radiological assessments defined by standard care (not by specific time frame) | 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 |
| Overall survival | week 1, date of patient death | Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death. |
| Auto-immune adverse event frequency | baseline, week 53 or at the progression | Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells |
| Subtype of melanoma correlated with biological characteristics of immune cells | baseline | Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells |
| Immunity gene polymorphism correlated with biological characteristics of immune cells | Week 1, week 3, week 7, week 13, week 53 or at the progression. | Immunity gene polymorphism defined by RNA sequencing correlated with biological characteristics of immune cells immune cells |
Countries
France
Outcome results
None listed