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NCT03421652 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo
A Phase 2 study of Stage IV Bladder Urothelial Carcinoma AJCC v7 and Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03421652: Completed Phase 2 study of Stage IV Bladder Urothelial Carcinoma AJCC v7 and Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT03421652 is a Phase 2 study of Stage IV Bladder Urothelial Carcinoma AJCC v7 and Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 20 participants, below the 546-participant average among 5 other Stage IV Bladder Urothelial Carcinoma AJCC v7 trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03421652, a Phase 2 study of Stage IV Bladder Urothelial Carcinoma AJCC v7 and Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well nivolumab works with radiation therapy in treating patients with urothelial bladder cancer that has spread from its original site of growth to nearby tissues or lymph nodes and are ineligible for chemotherapy. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab and radiation therapy may work better in treating patients with urothelial bladder cancer.
Primary Outcome
PFS distribution will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for PFS will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (12-month PFS rate, median PFS, etc.) will be calculated from the K-M life table, each one with its respective 90% confidence interval (CI).
Conditions Studied
Interventions
- DRUG Nivolumab
- RADIATION Radiation
Study Locations (2)
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2023-03-23 |
| Phase | Phase 2 |
What the finished NCT03421652 record still lists
NCT03421652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 546-participant average among 5 other Stage IV Bladder Urothelial Carcinoma AJCC v7 trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Stage IV Bladder Urothelial Carcinoma AJCC v7 appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03421652 reports a single indexed study location in Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT03421652 about?
NCT03421652 is a clinical study titled "Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo". This phase II trial studies how well nivolumab works with radiation therapy in treating patients with urothelial bladder cancer that has spread from its original site of growth to nearby tissues or lymph nodes and are ineligible for chemotherapy. Monoclonal antibodies, such as nivolumab, may interfe...
What is the current status of trial NCT03421652?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-04-24. Estimated completion is 2023-03-23.
What conditions does trial NCT03421652 study?
This clinical trial studies the following conditions: Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7.
What interventions are being tested in trial NCT03421652?
The interventions under investigation include: Nivolumab (DRUG), Radiation (RADIATION).
Who is sponsoring clinical trial NCT03421652?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03421652 being conducted?
This trial has 2 study locations across Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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