Blocking TNF to Enhance Immune Response in Melanoma Treatment
Blocking TNF to Potentiate the ICI-dependent Immune Awakening in Melanoma
This study is testing if blocking a specific protein can help improve the immune response in melanoma patients who are not responding well to their current treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, infliximab, certolizumab |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05867004 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of blocking Tumor Necrosis Factor alpha (TNF) to improve the immune response in patients with melanoma who are being treated with immune checkpoint inhibitors (ICI). It aims to clarify the pharmacodynamic impact of TNF inhibitors on immune and clinical responses, particularly in patients who do not respond to ICI therapy or experience severe immune-related adverse events. The study builds on previous findings that suggest TNF inhibitors can enhance the efficacy of ICIs and reduce adverse effects. Patients participating in this observational study are already enrolled in two related clinical trials, TICIMEL and MELANFalpha.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with advanced melanoma who are participating in the TICIMEL or MELANFalpha clinical trials.
Not a fit: Patients who are not enrolled in the TICIMEL or MELANFalpha trials may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for melanoma patients who currently do not respond to standard therapies.
How similar studies have performed: Previous studies have shown promising results in enhancing ICI efficacy with TNF inhibitors in preclinical models, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion in TICIMEL clinical trial (NCT03293784), * Inclusion in MELANFα trial (NCT03348891) Exclusion Criteria: * NA
Where this trial is running
Toulouse
- Institut Claudius Regaud — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Bruno SEGUI, Pr — Cancer Research Center of Toulouse
- Study coordinator: Bruno SEGUI, Pr
- Email: bruno.segui@inserm.fr
- Phone: +33 (0)5 82 74 16 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.