Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer

Summary

This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer. Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. Subjects may continue to receive the study regimen until they experience disease progression or unacceptable toxicity.

Timeline

Start

2018-02-08

Primary completion

2023-06-23

Completion

2023-06-23

Publications

• Tsung I, Green E, Palmbos P, Sloan Z, Reichert ZR, Vaishampayan U, Smith DC, Caram MEV, Yentz S, Daignault-Newton S, Hurley L, Nguyen CB, Kraft S, Alva A. A Phase 2 Trial of Nab-paclitaxel in Combination With Anti-PD1 Therapy in Advanced Urothelial Cancer. J Urol. 2023 Jan;209(1):121-130. doi: 10.1097/JU.0000000000002969. Epub 2022 Nov 1.

Drugs

Indications