Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Nivolumab

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3

Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery

Nab-Paclitaxel

Wks 1,2,3 before surgery and Wks 1,2,3 after surgery

Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery

Paricalcitol

Peter O'Dwyer, MD

The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. The study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.

A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

An adverse event (AE) was defined as any unfavorable symptom, sign, illness or experience that occurs at any dose and develops or worsens in severity during the course of the study. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Objective response rate by RECIST v 1.1 after neoadjuvant chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Proportion of patients alive without progression 1 year from the start of study therapy

Proportion of patients who underwent surgical resection after receiving neoadjuvant therapy

Overall survival 1 year after the initiation of study therapy

Proportion of patients undergoing surgical resection with surgical margins uninvolved by tumor

Abramson Cancer Center at Penn Medicine

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3

Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery

Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery

Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery

Arm A

Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3

Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery

Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery

Spots Global Cancer Trial Database for A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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