Trials / Completed
CompletedNCT03240016
Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer
ABLE: Phase II, Single Arm, Two-stage Study of Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | 200mg IV D1 |
| DRUG | Abraxane | 100mg/m\^2 D1 and D8 |
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2023-06-23
- Completion
- 2023-06-23
- First posted
- 2017-08-04
- Last updated
- 2025-01-16
- Results posted
- 2025-01-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03240016. Inclusion in this directory is not an endorsement.