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NCT06809140 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Matthew Galsky.

Recruiting
Registry status
Phase 2
Development phase
47
Enrollment target
5
Study locations

NCT06809140 is a Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma that is actively recruiting participants, run by Matthew Galsky. The registered enrollment target is 47 participants, below the 606-participant average among 5 other Muscle Invasive Bladder Urothelial Carcinoma trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT06809140, a Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Matthew Galsky.

RECRUITING
Registry status
Phase 2
Development phase
47 participants
Enrollment target
5
Study locations

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 Studied

Muscle Invasive Bladder Urothelial Carcinoma

Interventions

  • DRUG Pembrolizumab
  • DRUG Enfortumab vedotin

Study Locations (5)

New York

  • Icahn School of Medicine at Mount Sinai - New York
  • Columbia University Irving Medical Center - New York

California

  • City of Hope - Duarte

Indiana

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2025-04-07
Est. Completion 2029-11
Phase Phase 2

Sponsor

Matthew Galsky

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06809140

The ClinicalTrials.gov registry entry for NCT06809140 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 606-participant average among 5 other Muscle Invasive Bladder Urothelial Carcinoma trials with a reported enrollment target (92% lower). The listed sponsor is Matthew Galsky, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Muscle Invasive Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT06809140 reports 5 study locations spanning 4 distinct geographic areas - top geographies include New York, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT06809140 about?

NCT06809140 is a clinical study titled "Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer". 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 ach...

What is the current status of trial NCT06809140?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2025-04-07. Estimated completion is 2029-11.

What conditions does trial NCT06809140 study?

This clinical trial studies the following conditions: Muscle Invasive Bladder Urothelial Carcinoma.

What interventions are being tested in trial NCT06809140?

The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).

Who is sponsoring clinical trial NCT06809140?

This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06809140 being conducted?

This trial has 5 study locations across California, Indiana, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.