Back to resultsImmune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies (PAIR)
Primary Purpose
Metastatic Melanoma
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
blood sampling
Nivolumab
Sponsored by
About this trial
This is an interventional other trial for Metastatic Melanoma focused on measuring Melanoma, Anti-PD1 monoclonal antibodies, Immune modulation, BRAF
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
Sites / Locations
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nivolumab, patients with BRAF mutation
Nivolumab, patients with BRAF wild type
Arm Description
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 (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
Outcomes
Primary Outcome Measures
change the absolute number of dendritic cells before treatment and on treatment
absolute number / mm 3 of dendritic cells
change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment
% of cells producing cytokines in dendritic cells
change the absolute number of subpopulations of T lymphocytes before treatment and on treatment
absolute number / mm 3 of different subpopulations of T lymphocyte
change the absolute number of monocytes before treatment and on treatment
absolute number / mm 3 of monocytes
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
change the percentage of cells producing cytokines in monocytes before treatment and on treatment
% of cells producing cytokines in monocytes
Secondary Outcome Measures
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
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
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
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
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
Full Information
NCT ID
NCT02626065
First Posted
December 3, 2015
Last Updated
August 18, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02626065
Brief Title
Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
Acronym
PAIR
Official Title
Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2015 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, Anti-PD1 monoclonal antibodies, Immune modulation, BRAF
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab, patients with BRAF mutation
Arm Type
Experimental
Arm Description
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
Arm Title
Nivolumab, patients with BRAF wild type
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
blood sampling
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
change the absolute number of dendritic cells before treatment and on treatment
Description
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)
Title
change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment
Description
% 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)
Title
change the absolute number of subpopulations of T lymphocytes before treatment and on treatment
Description
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)
Title
change the absolute number of monocytes before treatment and on treatment
Description
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)
Title
change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment
Description
% 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)
Title
change the percentage of cells producing cytokines in monocytes before treatment and on treatment
Description
% 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)
Secondary Outcome Measure Information:
Title
correlation between biological parameters and progression-free survival
Description
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
Title
correlation between biological parameters on overall survival
Description
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
Title
Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria
Description
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
Title
impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment
Description
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
Title
correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
12. IPD Sharing Statement
Learn more about this trial
Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
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