Combining Immunotherapy and Radiation to Help Avoid Bladder Removal in Muscle Invasive Bladder Cancer: BRIGHT Trial
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07061964
This study is testing if combining the immunotherapy drug pembrolizumab with radiation therapy after chemotherapy can help patients with muscle invasive bladder cancer avoid surgery to remove the bladder.
Patient Parameters
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Program Overview
This phase II trial is exploring whether using the immunotherapy drug pembrolizumab along with radiation therapy after chemotherapy can prevent the need for bladder removal surgery in patients with muscle invasive bladder cancer. Typically, chemotherapy is used before surgery to shrink or eliminate the tumor. Pembrolizumab is a type of immunotherapy that may help the immune system attack the cancer and stop it from growing. Radiation therapy uses high-energy rays to kill cancer cells. This study aims to see if this combination can help patients keep their bladder intact.
Description
The main goal of this study is to see if at least 70% of patients can keep their bladder intact for three years after receiving radiation and pembrolizumab following chemotherapy. Other goals include measuring how long patients remain free from cancer recurrence, how long they live without the cancer spreading, and their overall survival. The study will also look at how often patients need bladder removal surgery and the side effects of the treatment.
Patients will receive radiation therapy daily from Monday to Friday for up to 20 sessions and pembrolizumab through an IV every 21 days for up to 18 cycles (about 12 months), as long as the cancer does not progress or cause unacceptable side effects. Patients will also have procedures to collect tissue samples and undergo various scans and tests throughout the study.
After completing the treatment, patients will have follow-up visits every six months for two years, then annually for up to five years.
Eligibility Criteria
Inclusion Criteria
- Must have muscle invasive bladder cancer confirmed by tests within 180 days before starting chemotherapy.
- Must have had scans of the chest, abdomen, and pelvis within 60 days before starting chemotherapy to confirm the cancer stage.
- Must have had a procedure to remove bladder tumors and biopsies within 60 days after the last chemotherapy dose, showing the cancer is at an early stage.
- Must have imaging tests of the chest, abdomen, and pelvis using CT, MRI, or PET scans within 60 days after the last chemotherapy dose.
- Must not have cancer that has spread beyond the bladder or other types of bladder cancer.
- Must have received 3 to 6 cycles of chemotherapy according to guidelines.
- Must not have had previous pelvic radiation or certain immunotherapy drugs.
- Must not have received a live vaccine within 28 days before joining the study.
- Must not be taking high doses of steroids or other immunosuppressive drugs.
- Must be 18 years or older.
- Must have a good performance status and meet specific blood test criteria.
- Must not have other cancers that could interfere with the study.
- Must not be pregnant or nursing and must agree to use effective contraception.
- Must be willing to participate in specimen banking and complete questionnaires if possible.
- Must provide informed consent to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Tower Cancer Research Foundation | 90211 | Beverly Hills | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Shaw Cancer Center | 81632 | Edwards | Colorado |
| Moffitt Cancer Center at SouthShore | 33570 | Ruskin | Florida |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center - McKinley Campus | 33612 | Tampa | Florida |
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