NCT05867004 Blocking TNF to Potentiate the ICI-dependent Immune Awakening in Melanoma
| NCT ID | NCT05867004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Claudius Regaud |
| Condition | Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-07-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-01-01 with a primary completion date of 2025-07-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cutaneous melanoma is a bad prognosis skin cancer, which can be treated with immune checkpoint inhibitors (ICI), such as anti-PD-1 (nivolumab, nivo) and anti-CTLA-4 (ipilimumab, ipi). However, about 50% of patients do not respond or relapse within 3 years post therapy induction, and immune-related adverse events (irAEs), such as colitis, are triggered and can be treated with TNF inhibitor (TNFi; ie, infliximab, inflix). The pharmacodynamic impact of TNFi on the immune and clinical responses remain to be clarified. The investigators previously demonstrated that TNFi enhance the efficacy of ICI in mouse melanoma models. Based on preclinical findings, the investigators implemented two clinical trials in advanced melanoma patients, TICIMEL and MELANFalpha. In TICIMEL, patients are concomitantly treated with TNFi \[certolizumab (certo) or inflix\] and ICI (ipi+nivo). In MELANFalpha, patients are treated with ICI alone. Preliminary results show both tritherapies promote systemic MART-1 specific CD8 T cell responses and that certo but not inflix may improve ICI efficacy and Th1 responses. In mouse melanoma models, TNFi enhance the response to ICI. Investigators' primary objective is to decipher how certolizumab and infliximab influence ICI-dependent anti-tumor immune responses in advanced melanoma patients. The secondary objectives are to analyse the cellular and molecular impact anti-TNF have on ICI-dependent anti-melanoma immune responses and clinical activities (irAEs and efficacy). By combining mouse and human data as well ex vivo functional assays, the investigators will dissect the impact treatments have on anti-melanoma immune responses by flow cytometry and transcriptomic analyses. The investigators expect to clarify (i) the mechanisms by which TNFi enhance ICI efficacy, (ii) identify the best TNFi to be combined with ICI in advanced melanoma patients and (iii) discover TNF-dependent biomarkers of resistance.
Eligibility Criteria
Inclusion Criteria: * Inclusion in TICIMEL clinical trial (NCT03293784), * Inclusion in MELANFα trial (NCT03348891) Exclusion Criteria: * NA
Contact & Investigator
Bruno SEGUI, Pr
PRINCIPAL INVESTIGATOR
Cancer Research Center of Toulouse
Frequently Asked Questions
Who can join the NCT05867004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05867004 currently recruiting?
Yes, NCT05867004 is actively recruiting participants. Contact the research team at bruno.segui@inserm.fr for enrollment information.
Where is the NCT05867004 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT05867004 clinical trial?
NCT05867004 is sponsored by Institut Claudius Regaud. The principal investigator is Bruno SEGUI, Pr at Cancer Research Center of Toulouse. The trial plans to enroll 100 participants.
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