Hoosier Cancer Research Network investigators will present their findings from the HCRN GU16-260 study during the 2022 American Society of Clinical Oncology Genitourinary Cancer Symposium meeting on Saturday, February 19. Investigators of HCRN GU16-260 will present the abstract titled, Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients with advanced clear cell renal cell (HCRN GU16-260-Cohort A): Final report.

The phase II clinical trial, known as HCRN GU16-260, involves front-line therapy with nivolumab and salvage therapy with nivolumab and ipilimumab. GU16-260 is led by Michael B. Atkins, MD of Georgetown Lombardi Comprehensive Cancer Center. The study helped researchers determine the activity of nivolumab, an agent already approved for patients with previously treated kidney cancer, in patients who have not received prior treatment.

Nivolumab is FDA approved for patients with VEGFR TKI-resistant renal cell carcinoma (RCC) and the nivolumab + ipilimumab combination is FDA approved for treatment naïve patients with International Metastatic RCC Database Consortium intermediate and poor risk renal cell carcinoma. Little information was available on the efficacy and toxicity of nivolumab monotherapy in treatment naïve renal cell carcinoma or the efficacy of nivolumab + ipilimumab salvage in patients with tumors resistant to initial nivolumab monotherapy.

The study found nivolumab monotherapy is active in treatment naïve clear cell renal cell carcinoma across all International Metastatic Renal Cell Carcinoma Database Consortium groups. Although efficacy appears less than combination Nivolumab + ipilimumab in I/P patients, favorable patients had a notably high objective response rate and duration of response. Efficacy appeared to correlate with tumor PD-L1 status, although at least half the responders had a tumor PD-L1 of 0. Salvage treatment with Nivolumab + ipilimumab after Nivolumab was frequently not feasible and of limited benefit.

View the abstract

Authors include: Michael B. Atkins, Opeyemi Jegede, Naomi B. Haas, David F. McDermott, Mehmet Asim Bilen, Jessica Hawley, Jeffrey A. Sosman, Robert S. Alter, Elizabeth R. Plimack, Moshe Chaim Ornstein, Michael E. Hurwitz, David J. Peace, Sabina Signoretti, Catherine J. Wu, Paul J. Catalano, Hans J. Hammers

Participating institutions include Georgetown Lombardi Comprehensive Cancer Center, Dana Farber Cancer Institute, Abramson Cancer Center, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Emory University School of Medicine, Columbia University Medical Center, Vanderbilt University Ingram Cancer Center, John Theurer Cancer Center, Hackensack University Medical Center, Fox Chase Cancer Center, Cleveland Clinic Cancer Center, Yale School of Medicine, University of Illinois at Chicago, Brigham and Women’s Hospital, Brigham and Women’s Hospital, UT Southwestern Medical Center.

About Hoosier Cancer Research Network

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.