Study on Enfortumab Vedotin and Pembrolizumab with Radiation for Muscle Invasive Bladder Cancer
Sponsor: University of California, San Francisco
ClinicalTrials ID:NCT06470282
This clinical trial is exploring a new treatment combination of enfortumab vedotin, pembrolizumab, and radiation therapy to see if it is safe and effective for patients with muscle invasive bladder cancer who are not candidates for surgery or prefer to keep their bladder.
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Program Overview
This study is testing a new treatment approach for muscle invasive bladder cancer using a combination of enfortumab vedotin, pembrolizumab, and radiation therapy. Enfortumab vedotin is a drug that targets cancer cells and delivers a powerful anticancer agent to them. Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. Radiation therapy uses precise beams to target the tumor while sparing healthy tissue. The study aims to find the best dose, check for side effects, and see how well this combination works in shrinking tumors and improving patient outcomes.
Description
The study is divided into two phases. In Phase Ib, researchers will determine the best dose of enfortumab vedotin when combined with pembrolizumab and radiation therapy, and assess the safety and side effects of this combination. In Phase II, the focus will be on evaluating how well the treatment works in achieving a complete response, meaning no signs of cancer, based on tests done six months after treatment.
Participants will receive enfortumab vedotin and pembrolizumab for up to five cycles of enfortumab vedotin and up to 17 cycles of pembrolizumab, unless the cancer progresses or side effects become unacceptable. Radiation therapy will be given alongside these treatments over a period of 6.5 to 8 weeks.
After completing the treatment, participants will have follow-up visits at 90 days and then every 12 weeks for up to five years to monitor their health and the effectiveness of the treatment.
The study will also explore changes in the tumor and immune system caused by the treatment, using advanced techniques to analyze tumor samples and immune cells.
Eligibility Criteria
Inclusion Criteria
- Must have muscle-invasive bladder cancer confirmed by a biopsy.
- Cancer must be mainly of the urothelial type, but some mixed types are allowed.
- Must be unable or choose not to have surgery to remove the bladder.
- Must be eligible for and agree to receive radiation therapy to the bladder.
- Must have had a procedure to remove as much of the tumor as possible within 8 weeks before starting the study treatment.
- Must be 18 years or older.
- Must have good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Must agree to use effective contraception during the study and for a specified period after the last dose of treatment.
- Must be able to understand and sign a consent form to participate in the study.
- HIV-positive individuals on effective treatment with undetectable viral load are eligible.
- Individuals with controlled hepatitis B or C infections are eligible.
Exclusion Criteria
- Cancer has spread to distant parts of the body or lymph nodes.
- Tumor sample shows small cell or neuroendocrine cancer type.
- No urothelial cancer type in the tumor sample.
- Untreated cancer in the upper urinary tract.
- Severe kidney swelling or extensive carcinoma in situ.
- Severe nerve damage or uncontrolled diabetes.
- Previous treatment with certain cancer therapies or investigational drugs within a specified time before the study.
- Recent major surgery or live vaccination.
- Active infections or other serious medical conditions that could interfere with the study.
- Pregnant or breastfeeding women are not eligible due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Francisco | 94143 | San Francisco | California |
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