Evans, RachelLee, KelvinWallace, Paul K.Reid, MaryMuhitch, JasonDozier, AskiaMesa, CirceLuaces, Patricia L.Santos-Morales, OrestesGroman, AdrienneCedeno, CarlosCinquino, AileenFisher, Daniel T.Puzanov, IgorOpyrchal, MateuszFountzilas, ChristosDai, TongErnstoff, MarcAttwood, KristopherHutson, AlanJohnson, CandaceMazorra, ZaimaSaavedra, DanayLeon, KaletLage, AgustinCrombet, TaniaDy, Grace K.2024-05-302024-05-302022-08-03Evans R, Lee K, Wallace PK, et al. Augmenting antibody response to EGF-depleting immunotherapy: Findings from a phase I trial of CIMAvax-EGF in combination with nivolumab in advanced stage NSCLC. Front Oncol. 2022;12:958043. Published 2022 Aug 3. doi:10.3389/fonc.2022.958043https://hdl.handle.net/1805/41101Background: CIMAvax-EGF is an epidermal growth factor (EGF)-depleting immunotherapy which has shown survival benefit as a switch maintenance treatment after platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC). The primary objective of this trial is to establish the safety and recommended phase II dose (RP2D) of CIMAvax-EGF in combination with nivolumab as second-line therapy for NSCLC. Methods: Patients with immune checkpoint inhibitor-naive metastatic NSCLC were enrolled using a "3+3" dose-escalation design. Toxicities were graded according to CTCAE V4.03. Thirteen patients (one unevaluable), the majority with PD-L1 0%, were enrolled into two dose levels of CIMAvax-EGF. Findings: The combination was determined to be safe and tolerable. The recommended phase 2 dose of CIMAvax-EGF was 2.4 mg. Humoral response to CIMAvax-EGF was achieved earlier and in a greater number of patients with the combination compared to historical control. Four out of 12 evaluable patients had an objective response.en-USAttribution 4.0 InternationalImmunotherapyLung cancerNon-small cell lung cancerImmune checkpoint inhibitorVaccineArticle