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NCT04936230 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04936230: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04936230 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04936230, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The addition of radiation to immunotherapy may shrink the cancer, but it could also cause side effects. Immunotherapy with monoclonal antibodies such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. The combination of pembrolizumab and radiation therapy may be more efficient in killing tumor cells.
Primary Outcome
Will be defined as a complete response (CR) or partial response (PR) as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Bone Scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-11-22 |
| Est. Completion | 2024-08-15 |
| Phase | Phase 2 |
Why NCT04936230 stopped before completion
NCT04936230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04936230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04936230 about?
NCT04936230 is a clinical study titled "Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer". This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The addition o...
What is the current status of trial NCT04936230?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2022-11-22. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT04936230?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT04936230?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04936230's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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