Phase 2 Sasanlimab PD-1 mAb trial for advanced renal cell carcinoma

This Phase 2 trial evaluates the safety and efficacy of a combination regimen in advanced clear cell or translocation renal cell carcinoma. Participants receive sasanlimab (a PD-1-targeted monoclonal antibody), palbociclib (a CDK4/CDK6 inhibitor), and axitinib (a VEGFR inhibitor) on 28-day cycles with staggered dosing and Bayesian monitoring of dose-limiting toxicities. The study, conducted in Boston under Stephanie Berg’s oversight, aims to define tolerability and potential clinical benefit. Contemporary front-line SoC for metastatic ccRCC uses PD-1/PD-L1 + TKI doublets (e.g., pembro-axi, len-pembro, nivo-cabo) or nivo + ipi; CDK4/6 isn’t standard, so this probes a resistance lever beyond approved doublets.