Enfortumab Vedotin Plus Pembrolizumab for Muscle-Invasive Bladder Cancer
This study is looking at a new way to treat muscle-invasive bladder cancer (MIBC). It combines two drugs, enfortumab vedotin and pembrolizumab, with the goal of avoiding bladder removal surgery for some patients. You would receive three cycles of these drugs, followed by tests to see how well the treatment worked. If your cancer is gone, you would continue with maintenance treatment for up to 14 cycles. If there's still cancer, you would have surgery to remove your bladder. The study aims to enroll 47 participants and is measuring how many patients achieve a complete response (cancer is no longer detectable) after 9 weeks. To join, you must be at least 18 years old and meet certain health criteria.
- Study design
- This is an interventional study planning to enroll 47 participants. It involves a specific treatment plan with two drugs.
- What's involved
- You would receive three cycles of treatment, followed by restaging tests. If successful, you would continue with maintenance treatment for up to 14 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 9 weeks, but treatment can continue for up to 14 cycles.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
At a glance
Conditions
NCT06809140
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope
Duarte, Californiastudy coordinator listed
Recruiting
Columbia University Irving Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New Yorkstudy coordinator listed
Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Matthew Galsky, MD · PRINCIPAL_INVESTIGATOR · Sponsor-Investigator
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC9 weeks
Clinical complete response rate will be defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab
- Bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response2 years
Estimate the 2-year bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response