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Immune Profiles Evolution Under Immunotherapy for Melanoma

NCT04576429 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

venous puncture

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).

PROCEDURE

tumoral biopsy

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Elisa FUNCK-BRENTANO, MD · Dermato-oncology department, Ambroise Paré hospital, APHP

  • Jean-François EMILE, MD, PhD · Pathology department, Ambroise Paré hospital, APHP

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576429 on ClinicalTrials.gov