PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer
Author
Bamias, Aristotelis
Huddart, Robert A.
Siefker-Radtke, Arlene O.
Balar, Arjun
Bilen, Mehmet A.
Powles, Thomas
Castellano, Daniel
Khalil, Maged F.
van der Heijden, Michiel S.
Koshkin, Vadim S.
Pook, David W.
ÖZGÜROĞLU, Mustafa
Santiago, Linda
Zhong, Bob
Chien, David
Lin, Wei
Tagliaferri, Mary A.
Loriot, Yohann
Metadata
Show full item recordAbstract
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).
Collections
- Makale [92796]