Trials / Active Not Recruiting
Active Not RecruitingNCT05923190
Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma
A Pilot Trial of Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Fox Chase Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a non-randomized two arm open-label phase 2 pilot study in adult subjects with locally advanced or metastatic urothelial cancer. The study will investigate an alternative administration schedule of EV given as monotherapy and in combination with pembrolizumab.
Detailed description
This is a non-randomized two arm open-label phase 2 pilot study in adult subjects with locally advanced or metastatic urothelial cancer. The study will investigate an alternative administration schedule of EV given as monotherapy and in combination with pembrolizumab. Approximately 50 patients will be enrolled to the main EV monotherapy cohort who are scheduled to receive EV as standard of care. Additionally, an exploratory arm will enroll 20 patients with metastatic urothelial cancer who are scheduled to receive EV in combination with pembrolizumab as standard of care. All subjects will have histologically and radiographically confirmed locally advanced or metastatic urothelial carcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and meet baseline laboratory data as outlined in the section 4.1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enfortumab vedotin | EV will be administered at standard dose of 1.25 mg/kg IV on days 1 and 8 with pembrolizumab 200 mg IV on day 1 of a 21-day cycle for 6 cycles |
| DRUG | Pembrolizumab | Pembrolizumab will be administered on day 1 of a 21-day cycle |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2028-07-01
- Completion
- 2029-07-01
- First posted
- 2023-06-28
- Last updated
- 2026-03-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05923190. Inclusion in this directory is not an endorsement.