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RECRUITING
NCT04576429
NA

Immune Profiles Evolution Under Immunotherapy for Melanoma

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2021-01-27

Completion Date

2031-01

Last Updated

2025-04-06

Healthy Volunteers

No

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.

Locations (1)

Dermato-oncology department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, France