OncoMatch/Clinical Trials/NCT07221942
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
Is NCT07221942 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enfortumab vedotin and Pembrolizumab for metastatic urothelial carcinoma.
Treatment: Enfortumab vedotin · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: monomethyl auristatin E-based antibody-drug conjugate
Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.
Lab requirements
Blood counts
absolute neutrophil count > 1,000/mm3 unless patient has constitutional neutropenia; platelets > 100,000/µl; hemoglobin > 8.0 g/dl
Kidney function
creatinine clearance >20 ml/min
Liver function
alt and ast <2.5 x uln or <3.5 x uln if liver metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fox Chase Cancer Center - Philadelphia · Philadelphia, Pennsylvania
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