As reported in the Journal of Clinical Oncology by Motzer et al, part B of the phase III CheckMate 914 trial showed no disease-free survival benefit with the adjuvant use of nivolumab vs placebo in patients with localized renal cell carcinoma at high risk of recurrence after nephrectomy. These results were consistent with Part A of the trial, which showed no disease-free survival benefit with nivolumab plus ipilimumab vs placebo in this setting.
Study Details
In part B of the trial, 825 patients from sites in 24 countries were randomly assigned 2:1:1 between March 2020 and March 2022 to receive nivolumab at 240 mg every 2 weeks for up to 12 doses (n = 411), placebo (n = 208), or nivolumab at 240 mg every 2 weeks for up to 12 doses plus ipilimumab at 1 mg/kg every 6 weeks for up to 4 doses (n = 206). The planned treatment duration was 24 weeks. The primary endpoint was disease-free survival on blinded independent central review for nivolumab vs placebo.
Key Findings
Median follow-up was 27.0 months (range = 18.0–42.4 months). Median disease-free survival was not reached in the nivolumab group or the placebo group; the rate at 18 months was 78.4% vs 75.% (hazard ratio [HR] = 0.87, 95% confidence interval [CI] = 0.62–1.21, P = .40).
Outcomes in the nivolumab/ipilimumab group were not statistically tested because of an absence of benefit with nivolumab/ipilimumab vs placebo in part A. In part B, median disease-free survival was not reached in the nivolumab/ipilimumab group, with an 18-month rate of 72.3%.
Grade 3 to 4 adverse events were reported in 17.2%, 15.0%, and 28.9% of patients given nivolumab, placebo, and nivolumab/ipilimumab, respectively. Treatment-related adverse events led to discontinuation of treatment in 9.6%, 1.0%, and 28.4% of patients, respectively.
The investigators concluded: “Part B of CheckMate 914 did not meet the primary endpoint of improved disease-free survival for nivolumab vs placebo in patients with localized [renal cell carcinoma] at high risk of postnephrectomy recurrence.”
Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Bristol Myers Squibb and Ono Pharmaceutical Company Ltd. For full disclosures of the study authors, visit ascopubs.org.
