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 anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care. For each included patient, blood samples will be collected at different time points. If feasible, an optional tumor biopsy specimen will be collected during baseline visit. All included patients will be followed-up for tumor response and toxicity until Week 12. After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
78
* Baseline * Week 6 Day 1 * Week 12 Day 1 If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center.
Chu Nantes
Nantes, 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
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