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Immune Profiles Evolution Under Immunotherapy for Melanoma

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT04576429 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • venous puncture
  • tumoral biopsy
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Where

1 site
Dermato-oncology department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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