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NCT06470282 · ClinicalTrials.gov registry record · Phase 1
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
A Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT06470282 is a Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 47 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06470282, a Phase 1 study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. 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 cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Enfortumab Vedotin
- RADIATION Intensity Modulated Radiation Therapy (IMRT)
- PROCEDURE Transurethral Resection of Bladder Tumor
- PROCEDURE Cystoscopy (CS)
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2025-03-31 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06470282
The ClinicalTrials.gov registry entry for NCT06470282 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06470282 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06470282 about?
NCT06470282 is a clinical study titled "Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer". This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, t...
What is the current status of trial NCT06470282?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2025-03-31. Estimated completion is 2028-01-31.
What conditions does trial NCT06470282 study?
This clinical trial studies the following conditions: Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT06470282?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Enfortumab Vedotin (DRUG), Intensity Modulated Radiation Therapy (IMRT) (RADIATION), Transurethral Resection of Bladder Tumor (PROCEDURE), Cystoscopy (CS) (PROCEDURE).
Who is sponsoring clinical trial NCT06470282?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06470282 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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