A Hoosier Cancer Research Network trial, HCRN-GU22-587, titled, “Advanced Renel Cell Cancer Combination Immunotherapy Clinical Trial,” was presented this week at the Kidney Cancer Research Summit (KCRS). Michael Serzan, MD (pictured right), of Dana-Farber Cancer Institute, presented the study as a trial in progress.
This study, led by Michael Atkins, MD (pictured left), of Georgetown University, is a randomized, open label, multicenter Phase II trial to evaluate the efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve patients with metastatic ccRCC.
The study will enroll 120 eligible patients randomized 2:1 to Arm A (Bot/Bal induction followed by Bal maintenance) or Arm B (Nivo/Ipi induction followed Nivo maintenance), each for a maximum of two years. Stratification factors include IMDC risk groups and sarcomatoid histology. The primary endpoint is overall response rate (ORR) per RECIST 1.1. This study utilizes a Simon’s two-stage design.
Learn more about this study: https://clinicaltrials.gov/study/NCT05928806
https://kcrs.kidneycan.org/kcrs24-program/
