Clinical Trials/NCT03519308

NCT03519308

Terminated

Early Phase 1

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

Abramson Cancer Center at Penn Medicine1 site in 1 country3 target enrollmentJuly 29, 2020

ConditionsPancreatic Cancer

InterventionsGemcitabine Nivolumab Nab-Paclitaxel Paricalcitol

DrugsNivolumab Nab-Paclitaxel Gemcitabine Paricalcitol

Overview

Phase: Early Phase 1
Intervention: Gemcitabine
Conditions: Pancreatic Cancer
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 3
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 29, 2020

End Date

April 18, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previously untreated, apparently resectable adenocarcinoma of the pancreas at registration.
•Age greater than or equal to 18 years
•ECOG performance status of 0-
•Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial.
•a. Note: subjects must have: Creatinine \< 2xULN, Neutrophils \>1.5x109/L, total bilirubin \< 3xULN, AST \<5xULN, ALT \<5xULN, and Platelets \>100,000/mm3
•Ability to provide written informed consent

Exclusion Criteria

•Subjects with hypercalcemia (blood levels greater than 11.5 mg/dL). In subjects creatinine clearance \<60mL/min, blood calcium levels must be 9.5 mg/dL or lower.
•Subjects who are currently pregnant, planning to become pregnant, or breast-feeding
•Females participants of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose
•Males participants with partners of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose
•Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
•Subjects with contraindications to immune checkpoint therapy, as follows:
•Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
•Prior organ allograft or allogeneic bone marrow transplantation
•Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
•Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator

Arms & Interventions

Arm A

Intervention: Gemcitabine

Arm A

Intervention: Nivolumab

Arm A

Intervention: Nab-Paclitaxel

Arm A

Intervention: Paricalcitol

Arm B

Intervention: Nivolumab

Arm B

Intervention: Nab-Paclitaxel

Arm B

Intervention: Gemcitabine

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: 18 months

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.