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

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ClinicalTrials.gov Identifier: NCT02626065
Recruitment Status : Unknown
Verified August 2017 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : December 10, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: blood sampling Drug: Nivolumab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
Actual Study Start Date : April 23, 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab, patients with BRAF mutation

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
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.
Experimental: Nivolumab, patients with BRAF wild type

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
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.


Outcome Measures
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Primary Outcome Measures :
  1. change the absolute number of dendritic cells before treatment and on treatment [ Time Frame: 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

  2. change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment [ Time Frame: 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

  3. change the absolute number of subpopulations of T lymphocytes before treatment and on treatment [ Time Frame: 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

  4. change the absolute number of monocytes before treatment and on treatment [ Time Frame: 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

  5. change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment [ Time Frame: 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

  6. change the percentage of cells producing cytokines in monocytes before treatment and on treatment [ Time Frame: 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


Secondary Outcome Measures :
  1. correlation between biological parameters and progression-free survival [ Time Frame: 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

  2. correlation between biological parameters on overall survival [ Time Frame: 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

  3. Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria [ Time Frame: 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

  4. impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment [ Time Frame: 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

  5. correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626065


Locations
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France
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02626065    
Other Study ID Numbers: 2014.884
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Hospices Civils de Lyon:
Melanoma
Anti-PD1 monoclonal antibodies
Immune modulation
BRAF
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents