Studies immune changes in melanoma patients receiving immunotherapy
Compares immune cell and blood marker levels before and after immunotherapy in melanoma patients.
Plain-language title generated from the registry record
Registry title: Immune Profiles Evolution Under Immunotherapy for Melanoma
Key facts
- Where
- Boulogne-Billancourt, FranceSee the site
Where in France
- Dermato-oncology department, Ambroise Paré hospital, APHPBoulogne-Billancourt, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT04576429
- Record updated
- 6 April 2025
- Original description
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.Read full original descriptionShow less
Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
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.
Inclusion: 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.
Exclusion: Patient receiving a immunosuppressor; Patient who participate to another blind interventional study receiving blinded treatment; Pregnant or breastfeeding woman; Patient refusal; Undergo a general corticotherapy of > 10 mg/kg/day since more than 7 days; Patient without any social protection by organization.