 Tumor assessments will be conducted every 6 weeks 7 days to week 18. Thereafter, these assessments will be done every 12 weeks 7 days. These will shall occur regardless of dose delays or dose interruptions, until Investigator-assessed progressive disease PD, or death, whichever occurs first. More frequent tumor assessments may be performed as clinically indicated, at the discretion of the treating Investigator. 