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Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

NCT02754726 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-27

Study results available
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Summary

The purpose of this study is to find out if the study drugs nivolumab, albumin- bound paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective when combined to treat advanced pancreatic cancer.

Conditions

  • Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

Nivolumab

Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle

DRUG

Albumin-bound paclitaxel

125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

DRUG

Paricalcitol

25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle

DRUG

Cisplatin

25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

DRUG

Gemcitabine

1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

Sponsors & Collaborators

  • Translational Genomics Research Institute

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Lustgarten Foundation

    collaborator OTHER

  • HonorHealth Research Institute

    lead OTHER

Principal Investigators

  • Erkut Borazanci, MD · HonorHealth Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2023-04-11
Completion
2024-03-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02754726 on ClinicalTrials.gov