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/

About Hoosier Cancer Research Network:
Hoosier Cancer Research Network conducts innovative cancer clinical trials in collaboration with more than 100 academic and community clinical research sites across the United States. Our studies are designed by cancer researchers from our member institutions. The HCRN staff includes 55 team members who work together to support all aspects of the studies we manage, from the time we receive the initial concept from a researcher through the final publication of the study results. Currently, we are supporting more than 70 clinical trials across a wide range of cancer types. Over our 40-year history, more than 10,000 participants in have enrolled in our clinical trials, leading to important discoveries that help cancer patients live longer and better after their cancer diagnosis.