Open AccessPIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer
Author(s) -
Robert Huddart,
Arlene Siefker-Radtke,
Arjun Vasant Balar,
Mehmet Asım Bilen,
Thomas Powles,
Aristotelis Bamias,
Daniel Castellano,
Mohamed Khalil,
Michiel S. van der Heijden,
Vadim S. Koshkin,
David Pook,
Mustafa Özgüroğlu,
Linda Santiago,
Bob Zhong,
David Chien,
Wei Lin,
Mary Tagliaferri,
Yohann Loriot
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2020-0795
Subject(s) - medicine , nivolumab , cisplatin , oncology , urothelial cancer , regimen , chemotherapy , metastatic urothelial carcinoma , phases of clinical research , chemotherapy regimen , cancer , bladder cancer , immunotherapy , urothelial carcinoma
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).