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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT07221942
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enfortumab vedotin — DRUG
    EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered at 200 mg IV on Day 1 of each 21-day cycle

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Feb 2026
Primary completion
Sep 1, 2028
Completion
Sep 3, 2029

Study Design

Enrollment
97 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Induction EV + Pembrolizumab Followed by Maintenance Pembrolizumab
    Participants will receive induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 6 cycles (approximately 18 weeks). EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle (starting dose of 1 mg/kg allowed), and pembrolizumab at 200 mg IV on Day 1 of each cycle. Patients achieving complete or partial response will transition to maintenance pembrolizumab at 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 pembrolizumab. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy.

Primary Outcome Measure

18-month progression-free survival (PFS) [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvania19111-2497
Pooja Ghatalia, MD
[email protected]

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By research site
Fox Chase Cancer Center - Philadelphia· Philadelphia, PA

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