Immune Profiles Evolution Under Immunotherapy for Melanoma
Recruiting now · Not applicable
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT04576429
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 360
- Starts
- 2021-01-27
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2025-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Dermato-oncology department, Ambroise Paré hospital, APHP — Boulogne-Billancourt, France (enrolling)
Full record on ClinicalTrials.gov
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