PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer.
The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and -negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).
Published In/Presented At
Huddart, R. A., Siefker-Radtke, A. O., Balar, A. V., Bilen, M. A., Powles, T., Bamias, A., Castellano, D., Khalil, M. F., Van Der Heijden, M. S., Koshkin, V. S., Pook, D. W., Özgüroğlu, M., Santiago, L., Zhong, B., Chien, D., Lin, W., Tagliaferri, M. A., & Loriot, Y. (2020). PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer. Future oncology (London, England), 10.2217/fon-2020-0795. Advance online publication. https://doi.org/10.2217/fon-2020-0795
Medicine and Health Sciences
Department of Medicine, Hematology-Medical Oncology Division