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NCT03214250 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

A Phase 1 study, sponsored by Parker Institute for Cancer Immunotherapy.

Completed
Registry status
Phase 1
Development phase
129
Enrollment target

NCT03214250: Completed Phase 1 study, sponsored by Parker Institute for Cancer Immunotherapy.

NCT03214250 is a Phase 1 study that has completed, run by Parker Institute for Cancer Immunotherapy. The registered enrollment target is 129 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03214250, a Phase 1 study, has completed, sponsored by Parker Institute for Cancer Immunotherapy.

COMPLETED
Registry status
Phase 1
Development phase
129 participants
Enrollment target

Study Summary

The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.

Primary Outcome

Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Interventions

  • DRUG Nivolumab
  • DRUG Nab-Paclitaxel
  • DRUG Gemcitabine
  • DRUG APX005M

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2017-07-21
Est. Completion 2022-02-25
Phase Phase 1

What the finished NCT03214250 record still lists

NCT03214250 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher).

The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.

NCT03214250 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03214250 about?

NCT03214250 is a clinical study titled "Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma". The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.

What is the current status of trial NCT03214250?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2017-07-21. Estimated completion is 2022-02-25.

What interventions are being tested in trial NCT03214250?

The interventions under investigation include: Nivolumab (DRUG), Nab-Paclitaxel (DRUG), Gemcitabine (DRUG), APX005M (DRUG).

Who is sponsoring clinical trial NCT03214250?

This trial is sponsored by Parker Institute for Cancer Immunotherapy, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03214250's enrollment target sits among peer trials

129 451st of 2000 higher than 1,549 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 NCT03214250, the US trial registry maintained by the National Library of Medicine. NCT03214250 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.