Study on Enfortumab Vedotin and Pembrolizumab for Treating Advanced or Metastatic Bladder Cancer with Uncommon Cell Types
Sponsor: Emory University
ClinicalTrials ID:NCT05756569
This clinical trial is exploring the effectiveness of combining enfortumab vedotin and pembrolizumab to treat patients with advanced or metastatic bladder cancer that has uncommon cell types. The study aims to see if this combination can help reduce tumors and improve patient outcomes.
Patient Parameters
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Program Overview
This phase II study is testing a new treatment for bladder cancer that has spread to nearby tissues or other parts of the body. The treatment combines two drugs: enfortumab vedotin, which targets cancer cells with a specific protein, and pembrolizumab, which helps the immune system fight cancer. The goal is to see if this combination can effectively kill cancer cells in patients with advanced or metastatic bladder cancer that has less common cell types.
Description
The main goal of this study is to see how well the combination of enfortumab vedotin and pembrolizumab works in shrinking tumors in patients with advanced bladder cancer. Researchers will measure the overall response rate to the treatment.
Secondary goals include evaluating how long patients live without the cancer getting worse, overall survival rates, and how long the response to treatment lasts. The study will also monitor the safety of the treatment by tracking any side effects for up to two years.
Additionally, researchers will explore changes in blood and tissue samples to better understand how the treatment affects the immune system and cancer cells.
Participants will receive the study drugs through an IV and will undergo regular scans and blood tests to monitor their progress throughout the trial.
Eligibility Criteria
Inclusion Criteria
- Must be male or female, aged 18 or older.
- Have a performance status that allows for daily activities with some restrictions.
- Have bladder cancer that has spread or cannot be removed by surgery, with specific uncommon cell types.
- Can have received any number of previous treatments or none at all.
- Must have tumor tissue samples available or agree to a biopsy.
- Must have measurable cancer that can be tracked by scans.
- Must have adequate organ and bone marrow function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
- Must have completed any previous cancer treatments at least four weeks before starting the study.
- Must have a life expectancy of more than 12 weeks.
- Must be willing to follow study procedures and attend scheduled visits.
Exclusion Criteria
- Cannot have certain types of bladder cancer, such as neuroendocrine or non-epithelial tumors.
- Cannot have had recent chemotherapy or radiation therapy within four weeks before starting the study.
- Cannot be participating in another clinical trial or using investigational drugs.
- Cannot have a history of severe allergic reactions to similar drugs.
- Cannot have ongoing nerve damage or neuropathy.
- Cannot have previously received enfortumab vedotin or pembrolizumab.
- Cannot have uncontrolled diabetes or active brain metastases.
- Cannot have another active cancer within the past two years, except for certain skin or prostate cancers.
- Cannot be receiving high-dose steroids or have active infections.
- Cannot be pregnant or breastfeeding.
- Cannot have a history of autoimmune diseases requiring treatment in the past two years.
- Cannot have certain heart conditions or other serious illnesses that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Grady Health System | 30303 | Atlanta | Georgia |
| Emory University Hospital Midtown | 30308 | Atlanta | Georgia |
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| Emory Saint Joseph's Hospital | 30342 | Atlanta | Georgia |
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