COLUMBUS, Ohio – The first kidney cancer clinical trial from the Big Ten Cancer Research Consortium shows that a two-drug combination warrants additional study in certain patients with advanced clear cell renal cell carcinoma (ccRCC). These findings were recently published in Nature Communications. Eric A. Singer, MD, director of urologic oncology and member of the Translational Therapeutics Program at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), led the research at OSUCCC – James for the consortium. “Advanced kidney cancer continues to be a challenge to treat,” said Singer. “We need new drugs and drug combinations to help improve both the length and quality of life for people with renal cell carcinoma. We believe the tolerability of this regimen and the progression-free survival seen in checkpoint inhibitor-naïve patients is worth further investigation.” Immune checkpoints are natural parts of the immune system that prevent the body’s immune response to viruses and bacteria from destroying healthy cells, too. However, these checkpoints can also hinder the immune system’s ability to destroy cancer cells. Drugs known as checkpoint inhibitors (CPIs) disrupt checkpoint activity and boost the immune system’s ability to fight cancer. The trial combined an experimental drug called guadecitabine (guah-dee-sye-ta-been) with the drug durvalumab (dur-val-ue-mab), which works to stimulate the immune system. In phase Ib of the trial, scientists found this drug combination to be safe with tolerable side effects among six patients. Researchers studied two groups in phase II: 36 patients who had not received CPIs, and 15 patients who had at least one previous treatment with CPIs. In the first group, the overall response rate (patients whose tumors were destroyed or reduced by the treatment) was 22%. The progression-free survival in this group was 14 months. In the second group, 60% of patients experienced stable disease, but their progression-free survival was just under 4 months. Based on results, Singer said the experimental combination had manageable side effects and promising anticancer activity, especially among patients not previously treated with CPIs. He said further research is needed to consider this combination as first and second lines of therapy for patients. To learn more about kidney cancer treatment and clinical trials at the OSUCCC – James, visit cancer.osu.edu. ### Media Contact: Mary Ellen Fiorino, Mary.Fiorino@osumc.edu