TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma

Phase 1 Completed 33 enrolled Institut Claudius Regaud

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

Timeline

Start: 2017-10-16
Primary completion: 2019-12-06
Completion: 2023-08-10

Outcome

Met primary endpoint

paper The two different combinations were found to be safe. PMID 33272982 ↗

Publications

Results Montfort A, Filleron T, Virazels M, Dufau C, Milhes J, Pages C, Olivier P, Ayyoub M, Mounier M, Lusque A, Brayer S, Delord JP, Andrieu-Abadie N, Levade T, Colacios C, Segui B, Meyer N. Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial. Clin Cancer Res. 2021 Feb 15;27(4):1037-1047. doi: 10.1158/1078-0432.CCR-20-3449. Epub 2020 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Certolizumab	Protein / enzyme biologic	200 mg	Other
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Other
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Other
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Other