Study objectives
SD, RCC
DISEASE, RCC
The primary objectives of phase 1b were to determine the RP2D for ibrutinib in each cohort: in combination with everolimus in RCC, docetaxel in GC, and cetuximab in CRC. Secondary objectives in phase 1b of each cohort included evaluation of the preliminary safety and tolerability, overall response rate (ORR) per RECIST v1.1, disease control rate (DCR; defined as complete response (CR), partial response (PR), or stable disease (SD) ≥ 6 weeks), duration of response (DOR), and pharmacokinetics of the combination regimens.The primary objectives of phase 2 were to assess progression-free survival (PFS) in the RCC cohort and ORR in the GC and CRC cohorts. Secondary objectives in phase 2 included PFS in GC and CRC cohorts, ORR in RCC cohort, and DCR, DOR, overall survival (OS), safety, and tolerability in each cohort.