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Completed

NCT Number: NCT02626065

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

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.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

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)

Nivolumab

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PAIR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2015
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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