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NCT03601455 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy and Durvalumab With or Without Tremelimumab in Treating Participants With Unresectable, Locally Advanced, or Metastatic Bladder Cancer
A Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Bladder Urothelial Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT03601455: Active Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Bladder Urothelial Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT03601455 is a Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Bladder Urothelial Carcinoma that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 85-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03601455, a Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects and how well radiation therapy and durvalumab with or without tremelimumab work in treating participants with bladder cancer that cannot be removed by surgery, has spread to nearby tissue or lymph nodes, or that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer.
Primary Outcome
Observed toxicities will be tabulated using frequencies and percentages based on the CTCAE v 4.03.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- RADIATION External Beam Radiation Therapy
- BIOLOGICAL Tremelimumab
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-10-26 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
What the registry record for NCT03601455 still lists
NCT03601455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 85-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Stage IV Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT03601455 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03601455 about?
NCT03601455 is a clinical study titled "Radiation Therapy and Durvalumab With or Without Tremelimumab in Treating Participants With Unresectable, Locally Advanced, or Metastatic Bladder Cancer". This phase II trial studies the side effects and how well radiation therapy and durvalumab with or without tremelimumab work in treating participants with bladder cancer that cannot be removed by surgery, has spread to nearby tissue or lymph nodes, or that has spread to other parts of the body. Radi...
What is the current status of trial NCT03601455?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2018-10-26. Estimated completion is 2027-01-31.
What conditions does trial NCT03601455 study?
This clinical trial studies the following conditions: Stage IV Bladder Cancer AJCC v8, Bladder Urothelial Carcinoma, Stage IVA Bladder Cancer AJCC v8, Stage IVB Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT03601455?
The interventions under investigation include: Durvalumab (BIOLOGICAL), External Beam Radiation Therapy (RADIATION), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03601455?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03601455 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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