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NCT05756569 · ClinicalTrials.gov registry record · Phase 2
Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
A Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 4
- Study locations
NCT05756569: Recruiting Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, sponsored by Emory University.
NCT05756569 is a Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 25 participants, below the 84-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (70% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05756569, a Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have 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. Enfortumab attaches to a protein called nectin-4 on cancer 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. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.
Primary Outcome
Will be measured by Response Evaluation Criteria in Solid Tumors version 1.1, and estimated by the Clopper-Pearson method with 95% confidence intervals.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Enfortumab Vedotin
- PROCEDURE Magnetic Resonance Imaging
Study Locations (4)
Georgia
- Grady Health System - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-09-26 |
| Est. Completion | 2027-12-16 |
| Phase | Phase 2 |
What NCT05756569 shows while recruiting
NCT05756569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 84-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (70% lower).
The record links to 10 conditions, with Stage IV Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05756569 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05756569 about?
NCT05756569 is a clinical study titled "Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology". This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first...
What is the current status of trial NCT05756569?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-09-26. Estimated completion is 2027-12-16.
What conditions does trial NCT05756569 study?
This clinical trial studies the following conditions: Stage IV Bladder Cancer AJCC v8, Stage III Bladder Cancer AJCC v8, Bladder Squamous Cell Carcinoma, Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma.
What interventions are being tested in trial NCT05756569?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Enfortumab Vedotin (DRUG), Magnetic Resonance Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT05756569?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05756569 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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