NCT04576429

Brief Summary

The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress53%
Jan 2021Jan 2031

First Submitted

Initial submission to the registry

September 14, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

9.9 years

First QC Date

September 14, 2020

Last Update Submit

April 4, 2025

Conditions

Melanoma

Keywords

melanomaimmunotherapyimmune profiles

Outcome Measures

Primary Outcomes (1)

  • Rate of relapse/progression-free survival

    Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment.

    at 5 years

Secondary Outcomes (1)

  • immunity profiles

    quarterly up to 12 months

Study Arms (2)

experimental group

EXPERIMENTAL
Procedure: venous punctureProcedure: tumoral biopsy

comparator group

ACTIVE COMPARATOR
Procedure: venous punctureProcedure: tumoral biopsy

Interventions

venous puncturePROCEDURE

Venous punctures will be performed: for patients of cohort A and B1: * before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline); * between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion); * each 3 months up to 12 months. for patients of cohort B2: * before the radiotherapy; * within the 6 weeks after the end of radiotherapy; * at the 2 following evaluations (every 3 months).

comparator groupexperimental group
tumoral biopsyPROCEDURE

Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.

comparator groupexperimental group

Eligibility Criteria

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

You may qualify if:

  • Patient aged ≥ 18 years;
  • Totally resected stage III or IV melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment;
  • Unresectable stage IIIC/D or IV metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ;
  • Patient has been informed about the study and signed the consent;
  • Affiliated to the French social security scheme.

You may not qualify if:

  • Pregnant or breastfeeding woman;
  • Patient refusal;
  • Patient receiving a immunosuppressor;
  • Undergo a general corticotherapy of \> 10 mg/kg/day since more than 7 days;
  • Patient who participate to another blind interventional study receiving blinded treatment;
  • Patient without any social protection by organization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermato-oncology department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

RECRUITING

MeSH Terms

Conditions

Melanoma

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

Study Officials

  • Elisa FUNCK-BRENTANO, MD

    Dermato-oncology department, Ambroise Paré hospital, APHP

    PRINCIPAL INVESTIGATOR

  • Jean-François EMILE, MD, PhD

    Pathology department, Ambroise Paré hospital, APHP

    STUDY DIRECTOR

Central Study Contacts

Elisa FUNCK-BRENTANO, MD

CONTACT

+33 (0)1 71 16 77 21elisa.funck-brentano@aphp.fr

Study Design

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

Study Record Dates

First Submitted

September 14, 2020

First Posted

October 6, 2020

Study Start

January 27, 2021

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)