Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change in the immune response by skin biopsy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Nivolumab
Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment.
30 patients will be included in the arm.
Intervention: Blood and biopsy sampling (Biological)
Nivolumab + Ipilimumab
Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment.
30 patients will be included in the arm.
Intervention: Blood and biopsy sampling (Biological)
Outcomes
Primary Outcomes
Change in the immune response by skin biopsy.
Time Frame: Week 1 (Baseline), week 7, week 53 or at the progression.
Change description of biological characteristics of immune cells of the blood 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
Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring
Secondary Outcomes
- Auto-immune adverse event frequency(baseline, week 53 or at the progression)
- Overall survival(week 1, date of patient death)
- Progression-free survival(Week1 , every radiological assessments defined by standard care (not by specific time frame))
- Subtype of melanoma correlated with biological characteristics of immune cells(baseline)
- Immunity gene polymorphism correlated with biological characteristics of immune cells(Week 1, week 3, week 7, week 13, week 53 or at the progression.)