RecruitingPhase 2NCT06809140

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

Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder

Sponsor

Matthew Galsky

Enrollment

47 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — enfortumab vedotin and pembrolizumab — as a treatment for muscle-invasive bladder cancer, with the goal of preserving the bladder instead of removing it surgically. **You may be eligible if...** - You are 18 or older - You have been diagnosed with muscle-invasive bladder cancer (stage T2-T3) that has not spread to lymph nodes or other organs - Your cancer is primarily a urothelial (bladder lining) type, making up at least 50% of the tumor - You recently had a procedure to remove as much tumor as possible from your bladder (TURBT, within 90 days) - You are in good general health (ECOG performance status 0-1) **You may NOT be eligible if...** - Your tumor contains any neuroendocrine (nerve cell) component - Cancer has spread to nearby lymph nodes (nodes 1 cm or larger on imaging) - You are not well enough to tolerate the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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