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NCT03912818 · ClinicalTrials.gov registry record · Phase 2
Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
A Phase 2 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03912818: Clinical Trial Phase 2 study, sponsored by Stanford University.
NCT03912818 is a Phase 2 study that was terminated before completion, run by Stanford University. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03912818, a Phase 2 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects of durvalumab and chemotherapy before surgery in treating patients with variant histology bladder cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, cisplatin, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab in addition to standard chemotherapy may lead to better outcomes in patients with variant histology bladder cancer.
Primary Outcome
Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The safety and tolerability of durvalumab in combination with chemotherapy in subjects with variant histology bladder cancer who initiate study treatment will be assessed as the number, by treatment cohort, of grade 3, 4, or 5 adverse events, considered probably or definitely related by the investigator.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Doxorubicin
- BIOLOGICAL Durvalumab
- PROCEDURE Cystectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2022-08-11 |
| Phase | Phase 2 |
Why NCT03912818 stopped before completion
NCT03912818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03912818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03912818 about?
NCT03912818 is a clinical study titled "Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer". This phase II trial studies the side effects of durvalumab and chemotherapy before surgery in treating patients with variant histology bladder cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in the body's immune system and may interfere with the ability of tu...
What is the current status of trial NCT03912818?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-04-10. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT03912818?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Doxorubicin (DRUG), Durvalumab (BIOLOGICAL), Cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03912818?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03912818's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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