NCT02754726

Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

A Phase II Pilot Trial of Nivolumab + Albumin-Bound Paclitaxel + Paricalcitol + Cisplatin + Gemcitabine (NAPPCG) In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: HonorHealth Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2023-04-11
• Completion: 2024-03-22
• First posted: 2016-04-28
• Last updated: 2025-08-27
• Results posted: 2024-12-10

Locations

1 site across 1 country: United States