This is an open-label Phase 1/2 study to assess the safety and tolerability of combination PD-1 inhibitor (nivolumab) administered concomitantly with c-Met inhibitor (APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain preliminary efficacy in subjects with advanced or metastatic Renal Cell Carcinoma that have not been previously treated with a PD 1 inhibitor or a c-Met inhibitor.
The frequency of administration of PD-1 inhibitors will be every 2 weeks starting in Cycle 1 on Day 8 and Day 22 of a 35-day cycle with all subsequent cycles on Day 1 and Day 15 of 28-day cycles. APL-101 will be administered orally every 12 hours continuously on an empty stomach.
