NCT03225365

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

July 17, 2017

Last Update Submit

September 11, 2025

Conditions

Metastatic Melanoma

Keywords

MelanomaNivolumabIpilimumabImmune modulation

Outcome Measures

Primary Outcomes (2)

  • Change description of biological characteristics of immune cells of the blood by immunomonitoring.

    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.

    Week 1 (Baseline), week 7, week 53 or at the progression.

Secondary Outcomes (5)

  • Progression-free survival

    Week1 , every radiological assessments defined by standard care (not by specific time frame)

  • Overall survival

    week 1, date of patient death

  • Auto-immune adverse event frequency

    baseline, week 53 or at the progression

  • Subtype of melanoma correlated with biological characteristics of immune cells

    baseline

  • Immunity gene polymorphism correlated with biological characteristics of immune cells

    Week 1, week 3, week 7, week 13, week 53 or at the progression.

Study Arms (2)

Nivolumab

OTHER

Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.

Biological: Blood and biopsy sampling

Nivolumab + Ipilimumab

OTHER

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

Interventions

Blood and biopsy samplingBIOLOGICAL

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.

NivolumabNivolumab + Ipilimumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

Pierre-Bénite, 69310, France

Location

Related Publications (1)

  • Dalle S, Verronese E, N'Kodia A, Bardin C, Rodriguez C, Andrieu T, Eberhardt A, Chemin G, Hasan U, Le-Bouar M, Caramel J, Amini-Adle M, Bendriss-Vermare N, Dubois B, Caux C, Menetrier-Caux C. Modulation of blood T cell polyfunctionality and HVEM/BTLA expression are critical determinants of clinical outcome in anti-PD1-treated metastatic melanoma patients. Oncoimmunology. 2024 Jun 26;13(1):2372118. doi: 10.1080/2162402X.2024.2372118. eCollection 2024.

    PMID: 38939518BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

October 10, 2019

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)