PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer.

Robert A Huddart
Arlene O Siefker-Radtke
Arjun V Balar
Mehmet A Bilen
Thomas Powles
Aristotelis Bamias
Daniel Castellano
Maged Khalil MD, Lehigh Valley Health Network
Michiel S Van Der Heijden
Vadim S Koshkin
David W Pook
Mustafa Özgüroğlu
Linda Santiago
Bob Zhong
David Chien
Wei Lin
Mary A Tagliaferri
Yohann Loriot


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).