All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Immunoglobulins

Nintedanib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

High tumor mutational burden (TMB-High) on their circulating tumor DNA (ctDNA) as defined by more than twenty mutations per megabase (≥20Mut/Mb) on FoundationOne Liquid CDx assay

Nintedanib oral tablets. An angiokinase inhibitor targeting VEGFR 1-3, FGFR 1-3, and PDGFR α/β as well as RET. Refer to current IB for product details

Pembrolizumab, Intravenous. An IgG4 anti-PD-1 blocking monoclonal antibody. Refer to current IB for product details

Aurélien Marabelle, MD

Matthieu Texier, MD

Antoine ITALIANO

Philippe Cassier

Carlos Gomez-Roca

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.

Trial Of Pembrolizumab And Nintedanib

Phase Ib Trial Of Pembrolizumab And Nintedanib

The primary endpoint is to determine the MTD of nintedanib based on the assessment of DLT occurrence during treatment Course 1.

Spots Global Cancer Trial Database for patients with any advanced solid tumors