TNF, a new target for immunotherapy ?
Pr Nicolas Meyer
Associate investigators : Dr Anne Montfort et Pr Bruno Ségui
Nearly 500 new cases of melanoma are treated each year by the Oncodermatology Unit of the IUCT-O, directed by Prof. N. Meyer, including about 150 new cases of advanced disease. Based on our preclinical studies, we are conducting the TICIMEL clinical trial (NCT03293784) in patients with metastatic melanoma (Principal Investigator: Prof. Nicolas Meyer; exploratory part: Prof. Bruno Ségui & Dr Anne Montfort; Sponsor: Institut Claudius Regaud). TICIMEL, which started in January 2018, is a phase 1b clinical trial to evaluate the safety of the combination of ICI (nivolumab plus ipilimumab) and anti-TNF (infliximab or certolizumab) in 30 patients with advanced melanoma.
We hypothesise that TNF blockade may improve the efficacy of ICI in melanoma patients. The primary objective of the study is to evaluate the safety of administering nivolumab and ipilimumab in combination with either certolizumab (Cohort 1) or infliximab (Cohort 2) in patients with advanced melanoma. The secondary objectives are to evaluate the safety and tolerability of both types of combination and the anti-tumour activity. The objectives of the exploratory part are to study the pharmacodynamic impact of the two types of combination on the anti-tumour immune response in blood and gene expression in tumours. The integration of all the data should allow us to identify biomarkers, including among ceramide metabolites, associated with a therapeutic response or resistance to both types of treatment.
Bristol-Myers Squibb; Association pour la Recherche sur le Cancer; Fondation Toulouse Cancer Santé