Patients
cancer vaccine, tumors, any-grade
ONCOLOGY, ADVERSE EVENT, SOLID TUMORS, TUMORS
This phase Ib study included patients with advanced, nonresectable, or recurrent solid tumors for which no alternative standard therapy or no effective therapy existed (patients eligible to receive nivolumab monotherapy as a standard of care were eligible for inclusion). Patients were ≥20 years of age, with a life expectancy of ≥12 weeks, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and adequate organ function. Patients were not eligible if they were previously treated with eribulin (including E7389-LF) or: any anti-PD-1, anti-PD-ligand 1 (PD-L1), anti-PD-L2, anti-CD137, anti-CTLA-4 antibody; any other antibody or drug specifically targeting T-cell costimulation or checkpoint; or cancer vaccine therapy that resulted in a grade ≥3 immune-related adverse event (irAE) or any-grade irAE leading to treatment discontinuation. Patients were also required to have tumors accessible for biopsy and had to consent to biopsy before and after treatment with study drug. A full list of inclusion and exclusion criteria can be found in the This study was conducted in accordance with standard operating procedures of the sponsor, which were based on the Principles of the World Medical Association Declaration of Helsinki, all applicable Japanese Good Clinical Practices and regulations, and the Pharmaceutical Affairs Law for studies conducted in Japan. Written informed consent was obtained from all participants and these and the study protocol were reviewed and approved by the applicable institutional ethical review board.