Washington University School of Medicine
This is a single center, phase Ib/II study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will augment the clinical activity of those two drugs.
Inclusion Criteria: * Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC. * Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the PD-L1 testing are not required for enrollment. * Measurable disease per RECIST 1.1. * At least 18 years of age. * ECOG performance status ≤ 1 * Adequate organ and marrow function, as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 9.0 g/dL * AS…
Ipilimumab will be given intravenously at a dose of 1mg/kg.
Nivolumab will be given intravenously at a dose of 360mg.
Nogapendekin alfa inbakicept will be given subcutaneously at the assigned dose level.
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