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Immune Profiles Evolution Under Immunotherapy for Melanoma
RECRUITINGN/ASponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
PhaseN/A
SponsorAssistance Publique - Hôpitaux de Paris
Started2021-01-27
Est. completion2031-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04576429
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
CancerMelanoma
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Actively Recruiting
PhaseN/A
SponsorAssistance Publique - Hôpitaux de Paris
Started2021-01-27
Est. completion2031-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04576429