Study on Risk-Adapted Treatment After Pre-Surgery Immunochemotherapy for Bladder Cancer
Sponsor: Fox Chase Cancer Center
ClinicalTrials ID:NCT04506554
This clinical trial is exploring a new treatment approach for muscle invasive bladder cancer (MIBC) using a combination of chemotherapy and immunotherapy before surgery. The study aims to see if this method can help some patients avoid surgery and keep their bladders, while still effectively treating the cancer.
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Program Overview
The study is testing a combination of chemotherapy drugs (methotrexate, vinblastine, adriamycin, and cisplatin) with an immunotherapy drug called nivolumab for treating muscle invasive bladder cancer (MIBC). The goal is to see if this treatment can help patients who have specific tumor mutations and respond well to the therapy to avoid surgery and instead be monitored closely. This approach could help maintain their quality of life by preserving their bladders.
Description
Muscle invasive bladder cancer (MIBC) is a serious form of bladder cancer that affects about 20-25% of patients. The usual treatment involves chemotherapy followed by surgery to remove the bladder, which can have significant side effects and impact quality of life. This study is testing a new approach that combines chemotherapy with an immunotherapy drug called nivolumab before surgery. The hope is that this combination can help more patients keep their bladders while still effectively treating the cancer.
Nivolumab is already approved for treating certain types of bladder cancer after chemotherapy. Previous studies have shown promising results with similar drugs, and researchers believe that combining nivolumab with chemotherapy could improve outcomes for patients with MIBC. The study will look at how well this treatment works in shrinking tumors and preventing the cancer from spreading over two years. If successful, this approach could allow some patients to avoid surgery and maintain a better quality of life.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Diagnosed with bladder cancer that is primarily urothelial carcinoma, confirmed by a pathology report. Some mixed types are allowed, but not upper tract urothelial carcinoma.
- Men with urothelial carcinoma in the prostatic urethra are eligible.
- Cancer must have invaded the muscle layer of the bladder.
- Clinical stage T2-T3 N0M0 according to specific medical criteria.
- No signs of cancer in the lymph nodes or other parts of the body.
- Good overall health with a performance status of 0 or 1.
- Heart function must be normal, with a left ventricular ejection fraction of 50% or higher.
- Women of childbearing potential must have a negative pregnancy test before joining the study.
- Normal organ and bone marrow function as shown by specific blood tests.
Exclusion Criteria
- Any small cell type of bladder cancer.
- Previous chemotherapy or radiation for bladder cancer or other cancers within the past year.
- Other active cancers that have progressed or required treatment in the last three years, except for certain skin cancers or treated prostate cancer.
- Recent use of experimental drugs or treatments.
- Allergies to the study drugs or similar medications.
- Uncontrolled health issues like infections, heart problems, or mental health conditions that could interfere with the study.
- Pregnant women due to potential risks to the baby.
- HIV-positive patients on certain treatments due to potential drug interactions and infection risks.
- Untreated kidney issues like hydronephrosis.
- Use of high-dose steroids or other immune-suppressing drugs recently.
- History of autoimmune diseases or previous treatment with certain immune therapies.
- Recent use of immune-stimulating drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| Thomas Jefferson University Hospital | 19107 | Philadelphia | Pennsylvania |
| Fox Chase Cancer Center - Philadelphia | 19111-2497 | Philadelphia | Pennsylvania |
| UT Southwestern Medical Center | 75390 | Dallas | Texas |
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