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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: Clinical Trial Phase 1 study, sponsored by Baylor Research Institute.

NCT02548169 is a Phase 1 study that was terminated before completion, run by Baylor Research Institute. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Follow up for toxicity will be recorded for the first 30 days following the last DC vaccination and any long-term toxicity will be followed for 3 years after completing study therapy.

Interventions

  • BIOLOGICAL DC Vaccine + Standard of Care Chemotherapy

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2015-08
Est. Completion 2017-04-24
Phase Phase 1
Baylor Research Institute

180 total trials

Why NCT02548169 stopped before completion

NCT02548169 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 1 intervention - of which DC Vaccine + Standard of Care Chemotherapy is the first listed.

NCT02548169 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02548169's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02548169, the US trial registry maintained by the National Library of Medicine. NCT02548169 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.