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NCT02548169 · ClinicalTrials.gov registry record · Phase 1
Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
A Phase 1 study, sponsored by Baylor Research Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02548169 is a Phase 1 study that was terminated before completion, run by Baylor Research Institute. The registered enrollment target is 7 participants.
The verdict
NCT02548169, a Phase 1 study, was terminated before completion, sponsored by Baylor Research Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer. The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.
Interventions
- BIOLOGICAL DC Vaccine + Standard of Care Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-04-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02548169
The ClinicalTrials.gov registry entry for NCT02548169 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DC Vaccine + Standard of Care Chemotherapy is the first listed.
NCT02548169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02548169 about?
NCT02548169 is a clinical study titled "Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer". The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer. ...
What is the current status of trial NCT02548169?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2015-08. Estimated completion is 2017-04-24.
What interventions are being tested in trial NCT02548169?
The interventions under investigation include: DC Vaccine + Standard of Care Chemotherapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT02548169?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
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