Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
- Registration Number
- NCT02626065
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
- Men and women aged ≥ 18 years
- Patient with metastatic or unresectable melanoma
- Anti-PD1 monoclonal antibodies treatment indication
- Patient affiliated to a social security regime
- Signed Written Informed Consent.
- agree with the storage of his biological samples
- Women of childbearing potential must as mentioned in the summary of product characteristics (SPC) using two effective methods of contraception during treatment, and men whose partner is of childbearing potential must use effective contraception during treatment. For all patients treated men and women, contraception should be continued during the four months following the discontinuation of nivolumab.
- development of haematological tumor during treatment
- Patients requiring concomitant chronic treatment with systemic corticosteroids or other immunosuppressive agents
- Patients with autoimmune disease.
- Patient with Occular melanoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab, patients with BRAF mutation blood sampling 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 Nivolumab, patients with BRAF mutation 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 Nivolumab, patients with BRAF wild type blood sampling 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 Nivolumab, patients with BRAF wild type 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
- Primary Outcome Measures
Name Time Method change the absolute number of dendritic cells before treatment and on treatment before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) absolute number / mm 3 of dendritic cells
change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) % of cells producing cytokines in dendritic cells
change the percentage of cells producing cytokines in monocytes before treatment and on treatment before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) % of cells producing cytokines in monocytes
change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) % of cells producing cytokines in subpopulations of T lymphocytes
change the absolute number of subpopulations of T lymphocytes before treatment and on treatment before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) absolute number / mm 3 of different subpopulations of T lymphocyte
change the absolute number of monocytes before treatment and on treatment before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) absolute number / mm 3 of monocytes
- Secondary Outcome Measures
Name Time Method correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment occurence of autoimmune side effects from day 0 to week 54 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
correlation between biological parameters and progression-free survival progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion 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
impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment antitumor treatment received from diagnosis of melanoma to inclusion 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
correlation between biological parameters on overall survival death between the date of first injection of immunotherapy and week 54 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
Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria response evaluation at week 12 predictive factors like histological and cytological initial tumor type, initial immunological status will be evaluated at inclusion and correlated with the response
Trial Locations
- Locations (1)
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France