Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma (IMMUNONIVO)

September 11, 2025 updated by: Hospices Civils de Lyon

Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).

This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

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
        • Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

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 of age.
  • Patient with metastatic or unresectable melanoma
  • Nivolumab or Nivolumab + Ipilimumab treatment indication
  • Skin biopsies available
  • Patient affiliated to or a beneficiary of a social security category.
  • Signed Written Informed Consent.
  • Patient who agrees to the storage of his biological samples

Exclusion Criteria:

  • Treated haematological malignancies Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Patients with autoimmune disease.
  • Ocular 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
Other: Nivolumab

Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment.

30 patients will be included in the arm.
Biological: Blood and biopsy sampling

Blood samples (52mL) will be taken at week 1, week 3, week 7, week 13, week 53 or at the progression.

Skin biopsies will be taken at week 1, week 7, week 53 or at the progression.
Other: Nivolumab + Ipilimumab

Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment.

30 patients will be included in the arm.
Biological: Blood and biopsy sampling

Blood samples (52mL) will be taken at week 1, week 3, week 7, week 13, week 53 or at the progression.

Skin biopsies will be taken at week 1, week 7, week 53 or at the progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change description of biological characteristics of immune cells of the blood by immunomonitoring.
Time Frame: Week 1 (baseline, before the 1st injection), week 3 (before the 2d injection treatment), week 7 (before the 4th) , week 13 (before the 5th), week 53 (before the 26th or during radiological evaluation) or at the progression
Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring
Week 1 (baseline, before the 1st injection), week 3 (before the 2d injection treatment), week 7 (before the 4th) , week 13 (before the 5th), week 53 (before the 26th or during radiological evaluation) or at the progression
Change in the immune response by skin biopsy.
Time Frame: Week 1 (Baseline), week 7, week 53 or at the progression.
Week 1 (Baseline), week 7, week 53 or at the progression.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Week1 , every radiological assessments defined by standard care (not by specific time frame)
Progression free survival (PFS) will be calculated as the period of time from the immunotherapy first administration to the first RECIST 1.1 disease progression
Week1 , every radiological assessments defined by standard care (not by specific time frame)
Overall survival
Time Frame: week 1, date of patient death
Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death.
week 1, date of patient death
Auto-immune adverse event frequency
Time Frame: baseline, week 53 or at the progression
Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells
baseline, week 53 or at the progression
Subtype of melanoma correlated with biological characteristics of immune cells
Time Frame: baseline
Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells
baseline
Immunity gene polymorphism correlated with biological characteristics of immune cells
Time Frame: Week 1, week 3, week 7, week 13, week 53 or at the progression.
Immunity gene polymorphism defined by RNA sequencing correlated with biological characteristics of immune cells immune cells
Week 1, week 3, week 7, week 13, week 53 or at the progression.

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)

October 10, 2019

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Estimated)

September 17, 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

  • 69HCL17_0043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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