A phase 3 study evaluating nivolumab (Opdivo) plus ipilimumab (Yervoy) as an adjuvant treatment in 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 its primary endpoint.

The randomized, double-blind, placebo-controlled CheckMate -914 trial (ClinicalTrials.gov Identifier: NCT03138512) evaluated the efficacy and safety of nivolumab plus ipilimumab in patients with localized RCC who underwent radical or partial nephrectomy and who were at high risk for relapse. In Part A of the trial, patients received nivolumab plus ipilimumab or placebo. 

Results showed that treatment with nivolumab plus ipilimumab did not meet the primary endpoint of disease-free survival, as assessed by blinded independent central review. The safety profile of nivolumab plus ipilimumab was consistent with that reported in previous studies in solid tumors.

“Even with notable progress in the treatment of metastatic renal cell carcinoma, there are still limited treatment options available for patients with localized disease,” said Dana Walker, MD, MSCE, vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Opdivo and Opdivo-based combinations have shown survival benefits in several earlier-stage and advanced cancers, including genitourinary tumors, and we are disappointed that the final analysis of CheckMate -914 Part A did not show this same benefit for the postsurgical treatment of patients with localized RCC.”

According to the Company, a full evaluation of Part A of trial data will be completed and shared with the scientific community. Part B of the study, in which nivolumab alone is being compared with placebo, is ongoing.

Reference

Bristol Myers Squibb provides update on CheckMate -914 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as adjuvant treatment of localized renal cell carcinoma. News release. Bristol Myers Squibb. Accessed July 29, 2022. https://www.businesswire.com/news/home/20220728006068/en/Bristol-Myers-Squibb-Provides-Update-on-CheckMate–914-Trial-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-as-Adjuvant-Treatment-of-Localized-Renal-Cell-Carcinoma