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NCT07475806 · ClinicalTrials.gov registry record · Phase 2
A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT07475806 is a Phase 2 study that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 240 participants.
The verdict
NCT07475806, a Phase 2 study, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term life-altering changes. There are also limited options for people who cannot have chemotherapy or who do not want their bladder removed. Studies show that enfortumab vedotin, when given with pembrolizumab, can help people with advanced bladder cancer. This treatment has also worked well for people with muscle-invasive bladder cancer who can't receive chemotherapy when it was given before and after bladder-removal surgery. However, some people can't have or won't have this surgery. There is still a need for new treatments that let people keep their bladder. This is especially important for people who respond well to the enfortumab vedotin, when given with pembrolizumab, and may benefit from continuing this study treatment instead of having surgery. The main aims of this study are to check how many people continue to respond well to enfortumab vedotin with pembrolizumab and how many people have their bladder intact after 2 years. People in this study will be adults who have muscle-invasive bladder cancer and are able to have surgery to remove the bladder. People cannot take part if they have nerve damage (sensory or motor neuropathy), have had certain other cancers, have diabetes that is not under control, or have had a transplant. People will receive infusions of enfortumab vedotin on the 1st and 8th day of 3-week (21-day) cycles. They will also receive pembrolizumab on the 1st day of every 3-week cycle. There will be safety checks at each visit with checks of the tumors at some visits. The doctors will continue to check for medical problems throughout the study. People will continue to receive study treatment unless their cancer doesn't improve after 9 cycles of study t
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2026-03-12 |
| Est. Completion | 2031-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07475806
The ClinicalTrials.gov registry entry for NCT07475806 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT07475806 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07475806 about?
NCT07475806 is a clinical study titled "A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder". People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term lif...
What is the current status of trial NCT07475806?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2026-03-12. Estimated completion is 2031-04-30.
What interventions are being tested in trial NCT07475806?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT07475806?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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