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NCT03319745 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT03319745: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03319745 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319745, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects of pembrolizumab and to see how well it works in treating patients with bladder cancer who are undergoing surgery to remove the bladder. 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.
Primary Outcome
The primary endpoint is a joint endpoint classifying patients as having a toxicity of concern (TOX), defined as the presence of any of these: 1) any 30-day grade 3 or higher surgical complication at least possibly related to the treatment, 2) any toxicity at least possibly related to the treatment that prevents surgery, or 3) death between the start of the study and the 30-day post-surgical assessment as long as it is at least possibly related to pembrolizumab or surgery.
Interventions
- BIOLOGICAL Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-01-11 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 2 |
What the finished NCT03319745 record still lists
NCT03319745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT03319745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03319745 about?
NCT03319745 is a clinical study titled "Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy". This phase II trial studies the side effects of pembrolizumab and to see how well it works in treating patients with bladder cancer who are undergoing surgery to remove the bladder. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, ...
What is the current status of trial NCT03319745?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-01-11. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT03319745?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03319745?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03319745's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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