Testing immune responses to predict melanoma treatment outcomes
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon
This study is testing if measuring certain immune signals in patients with advanced melanoma can help predict how well they will respond to a combination treatment of nivolumab and ipilimumab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | Nivolumab, Ipilimumab, immunotherapy |
| Locations | 3 sites (Nice, Alpes-maritimes and 2 other locations) |
| Trial ID | NCT05649683 on ClinicalTrials.gov |
What this trial studies
This study evaluates the immune response of patients with advanced melanoma undergoing combined immunotherapy with nivolumab and ipilimumab. It aims to identify predictive biomarkers, specifically levels of Th1, Th2, and Th17 cytokines, that correlate with treatment efficacy and tolerability. By analyzing cytokine production at the start and during treatment, the study seeks to establish a relationship between immune response and patient outcomes. The goal is to improve the management of immunotherapy by predicting which patients are likely to benefit from treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed advanced melanoma who are starting their first line of treatment.
Not a fit: Patients with ocular or mucosal melanoma, previous checkpoint inhibitor treatment, active brain metastasis, or those on immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with advanced melanoma.
How similar studies have performed: Previous studies have shown promise in using immune biomarkers to predict responses to immunotherapy, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion * persone of major age, * advanced melanoma confirmed, * RECIST 1.1 disease, * first line treatment Exclusion Criteria: * occular and mucosal melanoma, * previous checkpoint inhibitor treatment, * active brain metastasis, * concomitant immunosuppressive treatment
Where this trial is running
Nice, Alpes-maritimes and 2 other locations
- CHU de Nice - Hôpital de l'Archet — Nice, Alpes-maritimes, France (Recruiting)
- CHU de Montpellier — Montpellier, Occitanie, France (Recruiting)
- CHRU de Lille — Lille, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Montaudie Henri, PhD — CHU de Nice, Service de Dermatologie
- Study coordinator: Montaudie Henri, PhD
- Email: montaudie.h@chu-nice.fr
- Phone: 33492036083
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.