Outcomes
toxicity, toxicities, NSCLC, DLTs
SECONDARY, SOLID TUMORS, NSCLC, FEBRILE NEUTROPENIA
The primary objective of the study (both phases) was to assess the safety and tolerability of galunisertib in combination with nivolumab by identifying dose-limiting toxicities (DLTs) and the maximum tolerated dose or pharmacologically active dose of the combination in patients with advanced refractory or solid tumors during the first 2 cycles. DLTs were defined as Grade 3 non-haematologic toxicity; Grade 4 haematological toxicity of > 5 days duration; any febrile neutropenia.The secondary objectives of the study were to characterize the pharmacokinetics (PK) of galunisertib and nivolumab when co-administered, to characterize the immunogenicity of nivolumab when administered in combination with galunisertib, and to estimate the OS rate. In addition, PFS, ORR, and DOR were evaluated for patients with NSCLC in phase II. Exploratory objectives were to examine biomarkers and correlate these makers to clinical outcomes.