Study on Enfortumab Vedotin and Pembrolizumab vs. Standard Chemoradiotherapy for Muscle Invasive Bladder Cancer
Sponsor: Astellas Pharma Global Development, Inc.
ClinicalTrials ID:NCT07566156
This clinical trial is comparing two drugs, enfortumab vedotin and pembrolizumab, with the usual chemoradiotherapy treatment to see which is more effective for patients with muscle invasive bladder cancer that hasn't spread beyond the bladder.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out if the combination of two drugs, enfortumab vedotin and pembrolizumab, can be a better treatment option than the standard chemoradiotherapy for patients with muscle invasive bladder cancer (MIBC) that has not spread outside the bladder. The study will compare the effectiveness of these drugs against the usual treatment approach.
Description
This study is testing whether the combination of enfortumab vedotin and pembrolizumab is more effective than the standard treatment of chemoradiotherapy for people with muscle invasive bladder cancer that hasn't been treated before.
Participants may receive enfortumab vedotin for up to 9 cycles or until a specific reason to stop the study occurs. Pembrolizumab may be given for up to 17 cycles, with each cycle lasting 3 weeks, or until a specific reason to stop the study occurs. The standard chemoradiotherapy treatment may last for up to 6.5 weeks.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with muscle invasive bladder cancer (MIBC) with a specific type of cancer cell.
- Cancer must be confirmed through a tissue sample at the start of the study.
- Eligible and willing to receive chemoradiotherapy and one of the specified chemotherapy regimens.
- Suitable for systemic therapy and choose to preserve the bladder, including those who cannot or choose not to have bladder removal surgery.
- Have a performance status score of 0, 1, or 2, indicating varying levels of activity and ability to care for oneself.
Exclusion Criteria
- Cancer that has spread beyond the bladder or is a different type of bladder cancer.
- Received any previous treatment for muscle invasive or non-muscle invasive bladder cancer.
- Had radiation treatment in the pelvic area for any reason.
- Poor bladder function.
- Other active cancers within the last 3 years.
- Previously treated with enfortumab vedotin or similar drugs.
- Previously treated with PD-1 or PD-L1 inhibitors.
- Uncontrolled diabetes.
- Currently being treated for an active infection.
- Active hepatitis B, hepatitis C, or HIV infection.
- Had major surgery within 4 weeks before starting the study.
- Severe allergy to any ingredient in enfortumab vedotin.
- Genetic disorders that make radiation treatment risky.
- Active eye infections or ulcers.
- History of autoimmune diseases needing treatment in the last 2 years.
- History of certain lung diseases or active lung issues.
- Previous stem cell or organ transplant.
- Received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Samsun Clinic - Ridley-Tree Cancer Center | 93105 | Santa Barbara | California |
| Medical Oncology Hematology Consultants | 19713 | Newark | Delaware |
| Illinois Cancer Specialists | 60714 | Niles | Illinois |
| Williamette Valley Cancer Institute and Research Center | 97401 | Eugene | Oregon |
| Compass Oncology - West | 97223 | Tigard | Oregon |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology | 78705 | Austin | Texas |
| Texas Oncology - Northeast Texas | 75702 | Tyler | Texas |
| Virginia Oncology Associates | 23502 | Norfolk | Virginia |
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