OncoMatch/Clinical Trials/NCT07221942
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
Is NCT07221942 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07221942 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages