Laurence Albigès, MD, PhD, speaks to the patient population included in the phase 3 CheckMate 214 trial, assessing nivolumab plus ipilimumab in patients with treatment-naïve advanced or metastatic renal cell carcinoma.
In an interview with CancerNetwork® during the 2022 Genitourinary Cancers Symposium, Laurence Albigès, MD, PhD, a medical oncologist and head of the Genitourinary Unit at Gustave Roussy in Villejuif, discussed the patient population included in the phase 3 CheckMate 214 trial (NCT02231749).
The trial, which assessed the use of nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients with treatment-naïve advanced or metastatic renal cell carcinoma (RCC), enrolled patients with International Metastatic RCC Database Consortium (IMDC) intermediate- and poor-risk disease with at least 1 poor prognostic feature, according to Albigès.
The CheckMate 214 trial looked at patients with RCC who had metastatic disease that required first-line treatment. These patients could have any disease progression, either locally or at a metastatic level, and were not eligible for surgery but required systemic treatment. What is important in this trial is that the focus for the analysis is on the IMDC intermediate- and poor-[risk] patient population. These are patients who had at least 1 poor prognostic feature among 6 criteria that compose the IMDC classification. Overall, the [intent-to-treat] population in this trial also enrolled patients with [favorable]-risk disease. Nevertheless, the primary end point analysis was in the intermediate- or poor-risk population, which broadly accounted for 80% of our patient population.
Tannir NM, Signoretti S, Choueiri TK, et al. Efficacy and safety of nivolumab plus ipilimumab (N+I) versus sunitinib (S) for first-line treatment of patients with advanced sarcomatoid renal cell carcinoma (sRCC) in the phase 3 CheckMate 214 trial with extended 5-year minimum follow-up. J Clin Oncol. 2022;40(suppl 6):352. doi:10.1200/JCO.2022.40.6_suppl.352