A Phase 4 interventional study of blood sampling and Nivolumab in Metastatic Melanoma, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Hospices Civils de Lyon · Phase 4, Interventional, and Other
This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 32 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. Blood sampling at different time
Biological: blood sampling · Drug: Nivolumab
Nivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. Blood sampling at different time
Biological: blood sampling · Drug: Nivolumab
Blood samples (44mL) will be taken before starting treatment with Nivolumab and at week 2, week 12, week 54 or at relapse (before week 54)
injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks.
change the absolute number of dendritic cells before treatment and on treatment
absolute number / mm 3 of dendritic cells
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment
% of cells producing cytokines in dendritic cells
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the absolute number of subpopulations of T lymphocytes before treatment and on treatment
absolute number / mm 3 of different subpopulations of T lymphocyte
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the absolute number of monocytes before treatment and on treatment
absolute number / mm 3 of monocytes
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment
% of cells producing cytokines in subpopulations of T lymphocytes
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the percentage of cells producing cytokines in monocytes before treatment and on treatment
% of cells producing cytokines in monocytes
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
correlation between biological parameters and progression-free survival
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with the progression free survival
Time frame: progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion
correlation between biological parameters on overall survival
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with the overall survival
Time frame: death between the date of first injection of immunotherapy and week 54
Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria
predictive factors like histological and cytological initial tumor type, initial immunological status will be evaluated at inclusion and correlated with the response
Time frame: response evaluation at week 12
impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with treatments received prior to inclusion
Time frame: antitumor treatment received from diagnosis of melanoma to inclusion
correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with autoimmune side effects, based on CTCAE classification
Time frame: occurence of autoimmune side effects from day 0 to week 54
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon