Outcomes
tumor, SD, death
DISEASE, SECONDARY, TUMOR
The primary objective of this phase I dose-escalation trial was to determine the safety of the combined use of avelumab plus cabozantinib and to identify the RP2D in patients with mccRCC.The secondary objective was to define the preliminary clinical activity of the combination drug regimen. Secondary endpoints included: investigator-assessed confirmed objective response rate (ORR defined as the proportion of patients who achieve CR or PR using RECIST v1.1), disease control rate (DCR defined as the proportion of patients who achieve complete response [CR], partial response [PR], or stable disease [SD]), and radiological PFS. Radiographic tumor assessments were performed at baseline and repeated every 6 weeks. The post hoc analysis included reporting the duration of treatment, defined as the time from initiation of therapy until the start of next-line line therapy or death.