Bristol Myers Squibb announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) who have undergone full or partial removal of the kidney and who are at moderate or high risk of relapse, did not meet the primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR). The safety profile was consistent with previously reported studies of the Opdivo plus Yervoy combination in solid tumors. Opdivo and Opdivo-based combinations have demonstrated clinical benefits across several RCC patient populations, including: Opdivo plus Yervoy for the first-line treatment of patients with previously untreated, intermediate- and poor-risk RCC (CheckMate -214 trial), Opdivo and Opdivo plus Yervoy combined with a tyrosine kinase inhibitor for the first-line treatment of patients with previously untreated advanced RCC (CheckMate -9ER and COSMIC-313, respectively) and Opdivo for the second-line treatment of patients with previously treated advanced or metastatic RCC (CheckMate -025).

The company is also investigating Opdivo and Opdivo plus Yervoy in combination with novel agents targeting alternative immunomodulatory molecules and pathways in RCC. The company will complete a full evaluation of the available CheckMate -914 Part A data and work with investigators to share the results with the scientific community. CheckMate -914 is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Opdivo in combination with Yervoy compared to placebo (Part A), and Opdivo alone compared to placebo (Part B), in patients with localized renal cell carcinoma (RCC) who have undergone surgery to remove part or all of a kidney and who are at moderate to high risk of relapse.

Both parts of the study have a primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR). Key secondary endpoints include overall survival (OS) and incidence of adverse events (AEs). Part B of the study is ongoing.