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

September 11, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
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
before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
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
before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
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
before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
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
before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
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
before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion
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
death between the date of first injection of immunotherapy and week 54
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
response evaluation at week 12
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
antitumor treatment received from diagnosis of melanoma 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
occurence of autoimmune side effects from day 0 to week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2015

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimated)

December 10, 2015

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.884

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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