Immune Profiles Evolution Under Immunotherapy for Melanoma
Recruiting · NCT04576429 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
tumoral biopsyvenous puncture
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Dermato-oncology department, Ambroise Paré hospital, APHP - Boulogne-Billancourt, France