Study design and treatment
cancer
CANCER
This study was a multicenter, open‐label, Phase Ib study that was conducted in four centers in South Korea and two centers in Japan. Informed consent was obtained from patients before any study procedure was conducted. This study was performed in accordance with the Declaration of Helsinki and was consistent with the International Conference on Harmonization Good Clinical Practice Guidelines, applicable regulatory requirements, and the sponsor's policy on Bioethics and Human Biological Samples. The study protocol, its amendments, the informed consent form, and any information provided to the patients were approved by an independent ethical committee or institutional review board at each study center. The approval numbers for each study center are listed in Table The design of this study was based on nonclinical and clinical studies that have been conducted for tremelimumab, both as a monotherapy and as combination therapy with conventional anticancer agents, to support various cancer indications using different dose schedules.The study design consisted of a safety run‐in period, Part A, and an expansion period, Part B (Figure Study design. 