PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer.
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Embargo End Date
ICR Authors
Authors
Huddart, RA
Siefker-Radtke, AO
Balar, AV
Bilen, MA
Powles, T
Bamias, A
Castellano, D
Khalil, MF
Van Der Heijden, MS
Koshkin, VS
Pook, DW
Özgüroğlu, M
Santiago, L
Zhong, B
Chien, D
Lin, W
Tagliaferri, MA
Loriot, Y
Siefker-Radtke, AO
Balar, AV
Bilen, MA
Powles, T
Bamias, A
Castellano, D
Khalil, MF
Van Der Heijden, MS
Koshkin, VS
Pook, DW
Özgüroğlu, M
Santiago, L
Zhong, B
Chien, D
Lin, W
Tagliaferri, MA
Loriot, Y
Document Type
Journal Article
Date
2020-09-16
Date Accepted
Abstract
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).
Citation
Future oncology (London, England), 2020
Source Title
Publisher
TAYLOR & FRANCIS LTD
ISSN
1479-6694
eISSN
1744-8301
Collections
Research Team
Clinical Academic Radiotherapy (Huddart)