NCT04576429Recruiting
Immune Profiles Evolution Under Immunotherapy for Melanoma
Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 14 Sept 2020
- Start date
- 27 Jan 2021
- Primary completion date
- Jan 2031
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Melanoma
- NCT number
- NCT04576429
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 27 Jan 2021 to the primary completion date, Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receiving a immunosuppressor;
- Patient who participate to another blind interventional study receiving blinded treatment;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dermato-oncology department, Ambroise Paré hospital, APHP Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.