Table 1.
•The trifecta is necessary—presurgical priming with PD-1 blockade is required for efficacy |
•2 neoadjuvant doses of PD-1 inhibition may not be sufficient to eliminate micrometastatic disease and additional adjuvant therapy is warranted |
•Nivolumab monotherapy is established as safe and effective in second line metastatic RCC and will be employed as there is currently no proven PD-1 blocking combination therapy |
•A higher risk population by stage will be targeted but will be unselected by PD-L1 or other metric as there is no validated predictive marker at present |
•Patients will not be subjected to placebo |
•A mandatory upfront biopsy will ensure correct RCC diagnosis but also permits unparalleled correlative science |