Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Conditions

• Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
• Albumin-bound paclitaxel — DRUG
  125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
• Paricalcitol — DRUG
  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
• Cisplatin — DRUG
  25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
• Gemcitabine — DRUG
  1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

Study Details

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.

Key Dates

Start date

Apr 30, 2016

Status verified

Aug 2025

Primary completion

Apr 11, 2023

Completion

Mar 22, 2024

Study Design

Enrollment

35 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: single arm
  open label using combination therapy

Primary Outcome Measure

Complete Response Rate [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months ]

Locations (1)

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