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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

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 10, 2015
Last Update Posted Date August 22, 2017
Actual Study Start Date  ICMJE April 23, 2015
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
Official Title  ICMJE Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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

    Interventions:
    • Biological: blood sampling
    • Drug: Nivolumab
  • 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

    Interventions:
    • Biological: blood sampling
    • Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 18, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
40
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02626065
Other Study ID Numbers  ICMJE 2014.884
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP