Actively Recruiting
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
Led by Fox Chase Cancer Center · Updated on 2026-02-19
97
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and radiographically confirmed locally advanced, unresectable urothelial carcinoma
- No prior systemic therapy for metastatic disease
- Measurable disease with at least one lesion per RECIST v1.1
- Prior neoadjuvant or adjuvant immune checkpoint inhibitor allowed if completed at least 12 months prior
- ECOG performance status of 0 to 2
- Ability to understand and sign informed consent and HIPAA documents
- Archival tumor tissue available for correlative evaluation or attempt made to obtain
- Normal organ and marrow function including neutrophils > 1,000/mm3 (unless constitutional neutropenia), platelets > 100,000/µl, hemoglobin > 8.0 g/dL, ALT and AST < 2.5x upper limit of normal (or < 3.5x if liver metastases), creatinine clearance > 20 ml/min
You will not qualify if you...
- Prior treatment with monomethyl auristatin E-based antibody-drug conjugates for urothelial cancer
- Grade 2 or higher baseline sensory or motor neuropathy
- Uncontrolled diabetes with HbA1c > 8%
- Uncontrolled and untreated central nervous system metastases
- Leptomeningeal disease
- CNS metastases not stable for at least 6 weeks prior to screening
- Need for steroid treatment > 10 mg/day prednisone or equivalent for CNS metastases within 2 weeks prior to treatment
- Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, uncontrolled arrhythmia, or psychiatric/social conditions impairing compliance
- History of another invasive malignancy within 3 years requiring treatment or with residual disease
- Active systemic infection requiring antimicrobial treatment at first dose
- Known HIV-positive on combination antiretroviral therapy
- History of idiopathic pulmonary fibrosis or active pneumonitis
- Prior allogeneic stem cell or solid organ transplant
- Any medical condition or psychiatric/substance abuse disorder impairing ability to receive or tolerate treatment
- Active tuberculosis
- Pregnant or breastfeeding
- Active autoimmune disease requiring systemic treatment in past 2 years, except stable vitiligo, autoimmune hypothyroidism on hormone replacement, or type 1 diabetes on insulin
- High dose steroids (> 10 mg prednisone or equivalent) at enrollment, except inhaled or topical steroids
- Prior immunotherapy for metastatic urothelial carcinoma or other malignancy if stopped due to immune-related adverse events requiring immunosuppressive treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Actively Recruiting
Research Team
R
Ryan Romasko, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here