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NCT06764095 · ClinicalTrials.gov registry record · Phase 4
Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial
A Phase 4 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06764095: Recruiting Phase 4 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by Mayo Clinic.
NCT06764095 is a Phase 4 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 75 participants, below the 120-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06764095, a Phase 4 study of Metastatic Bladder Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and/or removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patients with bladder and upper urothelial tract that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Giving standard of care enfortumab vedotin and pembrolizumab followed by cytoreductive cystectomy and/or ureterectomy (CC/U) may improve outcomes in patients with locally advanced or metastatic bladder or upper urothelial tract cancer.
Primary Outcome
Will be calculated as the number of patients who are alive and progression-free at 12 months after study enrollment. Progression will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Enfortumab Vedotin
- PROCEDURE Cystectomy
- PROCEDURE Local Therapy
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-01-08 |
| Est. Completion | 2034-12-31 |
| Phase | Phase 4 |
What NCT06764095 shows while recruiting
NCT06764095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 120-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (37% lower).
The record links to 7 conditions, with Metastatic Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06764095 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06764095 about?
NCT06764095 is a clinical study titled "Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial". This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and/or removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patie...
What is the current status of trial NCT06764095?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2025-01-08. Estimated completion is 2034-12-31.
What conditions does trial NCT06764095 study?
This clinical trial studies the following conditions: Metastatic Bladder Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8, Stage III Bladder Cancer AJCC v8, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma.
What interventions are being tested in trial NCT06764095?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Enfortumab Vedotin (DRUG), Cystectomy (PROCEDURE), Local Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT06764095?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06764095 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06764095's enrollment target sits among peer trials
75 5th of 13 higher than 9 of 13 other Metastatic Bladder Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Bladder Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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