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Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma

NCT07221942 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-02-19

No results posted yet for this 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

  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma
  • Advanced Urothelial Carcinoma

Interventions

DRUG

Enfortumab vedotin

EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle

DRUG

Pembrolizumab

Pembrolizumab will be administered at 200 mg IV on Day 1 of each 21-day cycle

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Pooja Ghatalia, MD · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-23
Primary Completion
2028-09-01
Completion
2029-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221942 on ClinicalTrials.gov