This multi-center trial will be conducted in United States and Japan. The overall time to participate in this study is approximately 24 months. Participants will make multiple visits to the clinic, and participants in both Western cohort and disease specific cohort will be followed-up for up to 12 weeks for progression-free survival. Once disease progression is confirmed, participants in disease-specific cohort will be followed for overall survival for up to 12 weeks after last dose of study drug.