This phase III, randomized, double-blind, multicenter trial (IMmotion010) is enrolling patients with clear cell or sarcomatoid RCC at high risk for RCC recurrence after radical or partial nephrectomy, with lymphadenectomy allowed in select patients, high risk defined as T2N0M0 Fuhrman Grade 4, T3aN0M0 Fuhrman Grade 4 or higher, T3b/c & T4 with any Fuhrman grade, or any T stage or Fuhrman grade with lymph node positive disease. Similar to the KEYNOTE-564 trial, complete resection of limited synchronous or metachronous metastases is permitted. Patients are randomized 1:1 to receive either atezolizumab or placebo every 3 weeks for 16 cycles or 1 year unless there is unacceptable toxicity or disease progression. Patients will be stratified by stage and PD-L1 status.
Much as the aforementioned study, this study seeks to evaluate the role of immune checkpoint inhibitor therapy in the adjuvant setting. Atezolizumab, an anti-PD-L1 antibody, has demonstrated activity in the metastatic setting in RCC, in particular in combination with bevacizumab in the IMmotion150 and IMmotion151 trials.
The primary endpoint of IMmotion010 will be DFS as assessed by independent review facility (IRF). The secondary endpoints will be overall survival, and investigator-assessed DFS. IRF-assessed and investigatory-assessed DFS will also be evaluated based on tumor-infiltrating immune cell (IC) levels.