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NCT07221942 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
A Phase 2 study of Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, sponsored by Fox Chase Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT07221942 is a Phase 2 study of Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 97 participants, below the 127-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07221942, a Phase 2 study of Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, is actively recruiting participants, sponsored by Fox Chase Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled. Induction consists of EV (1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg/kg allowed) and P (200 mg IV on Day 1 of each cycle). Radiographic assessments occur after 3 and 6 cycles. Patients achieving complete or partial response transition to maintenance P (400 mg IV every 6 weeks or 200 mg IV every 3 weeks) for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for P. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients will enter long-term or survival follow-up as applicable.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab vedotin
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2026-01-23 |
| Est. Completion | 2029-09-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07221942
The ClinicalTrials.gov registry entry for NCT07221942 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 127-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (24% lower). The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT07221942 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07221942 about?
NCT07221942 is a clinical study titled "Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma". This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Appr...
What is the current status of trial NCT07221942?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2026-01-23. Estimated completion is 2029-09-03.
What conditions does trial NCT07221942 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma.
What interventions are being tested in trial NCT07221942?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT07221942?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07221942 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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