Analyzing immune profiles in melanoma patients undergoing immunotherapy
Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
NA · Assistance Publique - Hôpitaux de Paris · NCT04576429
This study is testing how immune system changes in melanoma patients receiving immunotherapy might relate to their chances of staying cancer-free or having their cancer come back.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | pembrolizumab, nivolumab |
| Locations | 1 site (Boulogne-Billancourt) |
| Trial ID | NCT04576429 on ClinicalTrials.gov |
What this trial studies
This study aims to compare immune profiles, specifically circulating cytokines and lymphocytes, in melanoma patients before and after receiving immune checkpoint inhibitors. Patients are divided into cohorts based on whether they are receiving treatment in the adjuvant or metastatic setting. The study will evaluate these immune profiles at baseline and during treatment to assess their association with relapse- or progression-free survival. The maximum duration of treatment is 12 months, with evaluations occurring at various points throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage III or IV melanoma who are receiving immune checkpoint inhibitors as part of their treatment.
Not a fit: Patients who are pregnant, breastfeeding, or receiving immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune responses to immunotherapy in melanoma, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have shown promise in analyzing immune profiles in cancer treatments, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boulogne-Billancourt
- Dermato-oncology department, Ambroise Paré hospital, APHP — Boulogne-Billancourt, France (RECRUITING)
Study contacts
- Principal investigator: Elisa FUNCK-BRENTANO, MD — Dermato-oncology department, Ambroise Paré hospital, APHP
- Study coordinator: Elisa FUNCK-BRENTANO, MD
- Email: elisa.funck-brentano@aphp.fr
- Phone: +33 (0)1 71 16 77 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma, melanoma, immunotherapy, immune profiles