Testing immune responses to predict melanoma treatment outcomes
Official title: Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors - Melanoma Quantiferon
Run by Centre Hospitalier Universitaire de Nice · NCT05649683 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | Nivolumab, Ipilimumab, immunotherapy |
| Locations | 3 sites (Nice, Alpes-maritimes and 2 other locations) |
| Status | Recruiting |
| Started | January 31, 2023 |
| Main results expected | February 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | June 4, 2024 |
| Trial ID | NCT05649683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with confirmed advanced melanoma who are starting their first line of treatment.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using immune biomarkers to predict responses to immunotherapy, suggesting this approach may be viable.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Assessing the safety and effectiveness of ENV-501 in patients with HER3-expressing solid tumors
This study is testing a new treatment called ENV-501 to see if it is safe and effective for people with advanced solid tumors that express HER3, like melanoma, lung cancer, and breast cancer.
-
Assessing a test to predict treatment response in advanced melanoma patients
This study tests if the IOpener® melanoma test can help predict how well treatment will work for people with advanced melanoma who are starting their first-line therapy.
-
Monitoring the effects of encorafenib and binimetinib in melanoma treatment
This study is testing how the levels of two melanoma drugs, encorafenib and binimetinib, affect side effects and treatment success in adults with a specific type of advanced melanoma.
-
Using Cyclophosphamide and Pembrolizumab for advanced melanoma treatment
This study is testing if a combination of Cyclophosphamide and Pembrolizumab can help people with advanced melanoma who haven't responded to other treatments feel better and improve their health.
-
Skipping full lymph node removal for stage III melanoma patients who show a strong response in the index node
This trial will see if patients with resectable stage III melanoma who get neoadjuvant ipilimumab plus nivolumab and show a major pathological response in the index lymph node can safely avoid therapeutic lymph node dissection.
-
Evaluating the DermaSensor device for detecting melanoma
This study is testing a new device to see if it can accurately detect skin lesions that might be melanoma in people aged 40 and older.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.