Clinical trial NCT02626065: Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
Official title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metastatic Melanoma
Keywords: Melanoma
Anti-PD1 monoclonal antibodies
Immune modulation
BRAF
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: change the absolute number of dendritic cells before treatment and on treatment
timeFrame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
measure: change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment
timeFrame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
measure: change the absolute number of subpopulations of T lymphocytes before treatment and on treatment
timeFrame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
measure: change the absolute number of monocytes before treatment and on treatment
timeFrame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
measure: change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment
timeFrame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
measure: change the percentage of cells producing cytokines in monocytes before treatment and on treatment
timeFrame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Secondary outcomes:
measure: correlation between biological parameters and progression-free survival
timeFrame: progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion
measure: correlation between biological parameters on overall survival
timeFrame: death between the date of first injection of immunotherapy and week 54
measure: Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria
timeFrame: response evaluation at week 12
measure: impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment
timeFrame: antitumor treatment received from diagnosis of melanoma to inclusion
measure: correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment
timeFrame: occurence of autoimmune side effects from day 0 to week 54
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References: