Trial Of Pembrolizumab And Nintedanib

Phase 1 Completed 196 enrolled Gustave Roussy, Cancer Campus, Grand Paris

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy for the benefit of the patients.

Timeline

Start: 2016-11-10
Primary completion: 2025-01-10
Completion: 2026-01-10

Publications

Baldini C, Danlos FX, Varga A, Texier M, Halse H, Mouraud S, Cassard L, Champiat S, Signolle N, Vuagnat P, Martin-Romano P, Michot JM, Bahleda R, Gazzah A, Boselli L, Bredel D, Grivel J, Mohamed-Djalim C, Escriou G, Grynszpan L, Bigorgne A, Rafie S, Abbassi A, Ribrag V, Postel-Vinay S, Hollebecque A, Susini S, Farhane S, Lacroix L, Parpaleix A, Laghouati S, Zitvogel L, Adam J, Chaput N, Soria JC, Massard C, Marabelle A. Safety, recommended dose, efficacy and immune correlates for nintedanib in combination with pembrolizumab in patients with advanced cancers. J Exp Clin Cancer Res. 2022 Jul 7;41(1):217. doi: 10.1186/s13046-022-02423-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nintedanib	Small molecule	150 mg	Oral
Subject	Nintedanib	Small molecule	200 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications

No indication recorded.