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Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

NCT06809140 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-02-23

No results posted yet for this study

Summary

Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.

Conditions

  • Muscle Invasive Bladder Urothelial Carcinoma

Interventions

DRUG

Enfortumab vedotin

1.25 mg/kg (maximum dose 125 mg)

DRUG

Pembrolizumab

200 mg

Sponsors & Collaborators

Principal Investigators

  • Matthew Galsky, MD · Sponsor-Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2027-11-30
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT06809140 on ClinicalTrials.gov