Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorCentre Hospitalier Universitaire de Nice
Academic / other
Drugs / interventionsNivolumab, Ipilimumab, immunotherapy
Locations3 sites (Nice, Alpes-maritimes and 2 other locations)
StatusRecruiting
StartedJanuary 31, 2023
Main results expectedFebruary 1, 2027
Study endsJune 1, 2027
Registry record updatedJune 4, 2024
Trial IDNCT05649683 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.