venous puncture: Venous punctures will be performed:
for patients of cohort A and B1:
* before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline);
* between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion);
* each 3 months up to 12 months.
for patients of cohort B2:
* before the radiotherapy;
* within the 6 weeks after the end of radiotherapy;
* at the 2 following evaluations (every 3 months).
tumoral biopsy: Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.
Study summary
The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient aged ≥ 18 years;
* Totally resected stage III or IV melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment;
* Unresectable stage IIIC/D or IV metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ;
* Patient has been informed about the study and signed the consent;
* Affiliated to the French social security scheme.
Exclusion Criteria:
* Pregnant or breastfeeding woman;
* Patient refusal;
* Patient receiving a immunosuppressor;
* Undergo a general corticotherapy of \> 10 mg/kg/day since more than 7 days;
* Patient who participate to another blind interventional study receiving blinded treatment;
* Patient without any social protection by organization.
Primary outcome measure(s)
Rate of relapse/progression-free survival — at 5 years Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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