CheckMate 914: Adjuvant Nivolumab Monotherapy for Patients With Localized RCC

Part B of the phase 3, double-blind CheckMate 914 trial led by Robert J. Motzer, MD, and presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium investigated adjuvant nivolumab monotherapy versus placebo in patients with localized renal cell carcinoma (RCC) at high risk of postnephrectomy relapse.

The first analysis conducted for CheckMate 914 evaluated adjuvant nivolumab plus ipilimumab versus placebo or adjuvant nivolumab monotherapy versus placebo. Results from that study demonstrated that adjuvant nivolumab versus placebo exhibited no disease-free survival (DFS) benefit.

The study’s second phase analyzed data from patients with RCC scheduled to undergo radical or partial nephrectomy. Researchers randomly assigned patients to receive either nivolumab 240 mg every 2 weeks for 12 cycles plus ipilimumab or placebo, nivolumab 240 mg every 2 weeks for 12 cycles plus ipilimumab, or a matching placebo.

The trial’s primary end point was DFS per blinded independent central review (BICR), and secondary end points included the safety of nivolumab monotherapy.

Of the 619 participating patients, 411 were randomized to the nivolumab group, and 208 were randomized to the placebo group.

Researchers found that within the 27-month follow-up range, the study did not meet the primary end point of DFS per BICR with nivolumab monotherapy versus placebo (hazard ratio, 0.87; 95% CI, 0.62-1.21; P=.3962). Neither of the study arms reached median DFS.

Patients in the nivolumab monotherapy cohort (72.5%) reported more any-grade treatment-related adverse events (TRAEs) than those in the placebo cohort (51.7%). In the nivolumab monotherapy cohort, 8.8% of patients experienced grade 3-4 TRAEs, while 1.9% of patients in the placebo cohort experienced the same.

Dr. Motzer and colleagues concluded that Part B of the CheckMate 914 study did not meet the primary end point of DFS.

They noted that the safety of nivolumab monotherapy treatment was consistent with previous RCC research.