A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC

Summary

This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB. The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.

Timeline

Start

2021-11-12

Primary completion

2024-05

Completion

2024-05

Publications

• Results Sanchez-Paulete AR, Labiano S, Rodriguez-Ruiz ME, Azpilikueta A, Etxeberria I, Bolanos E, Lang V, Rodriguez M, Aznar MA, Jure-Kunkel M, Melero I. Deciphering CD137 (4-1BB) signaling in T-cell costimulation for translation into successful cancer immunotherapy. Eur J Immunol. 2016 Mar;46(3):513-22. doi: 10.1002/eji.201445388. Epub 2016 Feb 9.
• Results Costantini A, Corny J, Fallet V, Renet S, Friard S, Chouaid C, Duchemann B, Giroux-Leprieur E, Taillade L, Doucet L, Nguenang M, Jouveshomme S, Wislez M, Tredaniel J, Cadranel J. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2):00120-2017. doi: 10.1183/23120541.00120-2017. eCollection 2018 Apr.
• Results Freeman AT, Lesperance M, Wai ES, Croteau NS, Fiorino L, Geller G, Brooks EG, Poonja Z, Fenton D, Irons S, Ksienski D. Treatment of non-small-cell lung cancer after progression on nivolumab or pembrolizumab. Curr Oncol. 2020 Apr;27(2):76-82. doi: 10.3747/co.27.5495. Epub 2020 May 1.
• Results Qi X, Li F, Wu Y, Cheng C, Han P, Wang J, Yang X. Optimization of 4-1BB antibody for cancer immunotherapy by balancing agonistic strength with FcgammaR affinity. Nat Commun. 2019 May 20;10(1):2141. doi: 10.1038/s41467-019-10088-1.

Drugs

Indications