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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
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
Clinical Trials Nurse Navigator
Scottsdale, Arizona, United States
Complete Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm.
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
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle