Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

Metastatic Melanoma Clinical Trial

— PAIR  

Official title:

Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02626065
• Other study ID #: 2014.884
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 3, 2015
• Last updated: August 18, 2017
• Start date: April 23, 2015
• Est. completion date: April 2018

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Biological:
• blood sampling
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)

Drug:
• Nivolumab
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change the absolute number of dendritic cells before treatment and on treatment	absolute number / mm 3 of dendritic cells	before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Primary	change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment	% of cells producing cytokines in dendritic cells	before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Primary	change the absolute number of subpopulations of T lymphocytes before treatment and on treatment	absolute number / mm 3 of different subpopulations of T lymphocyte	before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Primary	change the absolute number of monocytes before treatment and on treatment	absolute number / mm 3 of monocytes	before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Primary	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	before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Primary	change the percentage of cells producing cytokines in monocytes before treatment and on treatment	% of cells producing cytokines in monocytes	before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Secondary	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	progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion
Secondary	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	death between the date of first injection of immunotherapy and week 54
Secondary	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	response evaluation at week 12
Secondary	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	antitumor treatment received from diagnosis of melanoma to inclusion
Secondary	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	occurence of autoimmune side effects from day 0 to week 54