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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.
CHRU Claude HURIEZ
Lille, France
CHU Montpellier Saint-Eloi
Montpellier, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Time frame: 12 weeks per patient
Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.
Time frame: 12 weeks per patient
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Time frame: 12 months per patient
Progression Free Survival is defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Time frame: 12 months per patient
Immune related adverse event will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Time frame: 12 weeks per patient
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