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NCT02581982 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer
A Phase 2 study of Transitional Cell Carcinoma, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT02581982: Completed Phase 2 study of Transitional Cell Carcinoma, sponsored by Wake Forest University Health Sciences.
NCT02581982 is a Phase 2 study of Transitional Cell Carcinoma that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 27 participants, below the 179-participant average among 4 other Transitional Cell Carcinoma 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
NCT02581982, a Phase 2 study of Transitional Cell Carcinoma, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients with urothelial cancer that has not responded to previous treatment and has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, 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. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel together with pembrolizumab may be an effective treatment for urothelial cancer.
Primary Outcome
The overall response rate will be performed in all patients that are evaluable for efficacy and will have one interim analysis. Overall response is complete response (CR) = Disappearance of all target lesions (PR) = at least a 30% decrease in sum of diameters, taking as reference the baseline sum diameters; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters while on study; and progressive dise
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-04-06 |
| Est. Completion | 2022-12-19 |
| Phase | Phase 2 |
What the finished NCT02581982 record still lists
NCT02581982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 179-participant average among 4 other Transitional Cell Carcinoma trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Transitional Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02581982 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02581982 about?
NCT02581982 is a clinical study titled "Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer". This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients with urothelial cancer that has not responded to previous treatment and has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tu...
What is the current status of trial NCT02581982?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2016-04-06. Estimated completion is 2022-12-19.
What conditions does trial NCT02581982 study?
This clinical trial studies the following conditions: Transitional Cell Carcinoma.
What interventions are being tested in trial NCT02581982?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02581982?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02581982 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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