A randomized phase II trial of pazopanib (PAZ) vs. temsirolimus (TEM) in patients (pts) with advanced clear-cell renal cell carcinoma (accRCC) with intermediate or poor-risk disease (the TemPa trial).

4563Background: TEM has level 1 evidence in aRCC with poor-risk disease. No previous trial compared a VEGFR-TKI with TEM as first-line (1L) therapy. Methods: We randomly assigned (1:1) treatment-naive pts with accRCC and > = 3 risk factors (Hudes et al., NEJM 2007) to receive PAZ 800 mg po qd or TEM 25 mg iv qw. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR) and safety. A blinded radiologist assessed the radiographic response using RECIST v1.1. A sample size of 90 pts was based on an assumption of improved median PFS from 3.8 mo (TEM) to 6.1 mo (PAZ). Pts were stratified by prior nephrectomy (Nx) and prior cytokine therapy. The Kaplan-Meier method was used for PFS/OS analysis, and the Fisher’s exact test for comparison of ORR between PAZ and TEM. Results: TemPa was closed to new patient enrollment in Sept. 2017 after the results of CheckMate 214 and CABOSUN were released. A total of 69 pts were eligible and ev...