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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3
Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery
Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Number of Adverse Events
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.
Time frame: 18 months
Objective Response Rate
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.
Time frame: 3 months
Progression-free Survival
Proportion of patients alive without progression 1 year from the start of study therapy
Time frame: 1 year
Proportion of Patients Undergoing Surgery
Proportion of patients who underwent surgical resection after receiving neoadjuvant therapy
Time frame: 3 months
Overall Survival
Overall survival 1 year after the initiation of study therapy
Time frame: 1 year
Proportion of Margin Negative Surgical Resections
Proportion of patients undergoing surgical resection with surgical margins uninvolved by tumor
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery