Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma (NCT05923190)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (25 items).
Location: Fox Chase Cancer Center - Philadelphia — Philadelphia, Pennsylvania
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Both EV monotherapy and EV/pembrolizumab arms:
- Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.
- Grade 2 or higher baseline sensory or motor neuropathy.
- Uncontrolled diabetes (HbA1c \>8%)
- Patients with uncontrolled and untreated central nervous system (CNS) metastases.
- Prior radiation to CNS metastases is permitted.
- Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence.
- Patient should not have leptomeningeal disease
- CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
- If requiring steroid treatment for CNS metastases, the patient is on stable dose \< 20 mg/day of prednisone or equivalent for at least 2 weeks prior to starting treatment
- Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment. Adjuvant hormonal therapy for breast cancer is allowed.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Fox Chase Cancer Center - Philadelphia — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.