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Brief Title: TNF in Melanoma Patients Treated With Immunotherapy
Official Title: TNF in Melanoma Patients Treated With Immunotherapy
Study ID: NCT03348891
Brief Summary: This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma. The study will be conducted on a population of patients treated with ICI in the context of routine care, separated in two subgroups: * Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) * Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab) For each included patient, blood samples will be collected during baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1). If feasible, tumor biopsy (of primary tumor or metastasis) will be performed during baseline and on Week 12 Day 1 visit (predose). If tumor biopsy is not feasible, available archived tumor specimen (frozen or FFPE block) may be collected for the study. All included patients will be followed-up for tumor status and/or survival status every 3 months until a maximum duration of 1 year from the first study dose.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHRU Claude HURIEZ, Lille, , France
CHU Montpellier Saint-Eloi, Montpellier, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, , France