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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03519308
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Nivolumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Paricalcitol	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer
• Actual Study Start Date: Jul 29, 2020
• Actual Primary Completion Date: Apr 18, 2022
• Actual Study Completion Date: Apr 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A	Drug: Nivolumab; Before Surgery Wks 1 &3, After Surgery Wks 1 &3; Drug: Nab-Paclitaxel; Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery; Drug: Gemcitabine; Wks 1,2,3 before surgery and Wks 1,2,3 after surgery; Drug: Paricalcitol; Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery
Experimental: Arm B	Drug: Nivolumab; Before Surgery Wks 1 &3, After Surgery Wks 1 &3; Drug: Nab-Paclitaxel; Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery; Drug: Gemcitabine; Wks 1,2,3 before surgery and Wks 1,2,3 after surgery

Outcome Measures

Primary Outcome Measures

1. Numer of Adverse Events [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Previously untreated, apparently resectable adenocarcinoma of the pancreas at registration.

• Age greater than or equal to 18 years

• ECOG performance status of 0-2.

• 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.

1. 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

1. 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

2. 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 3. Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation 4. Subjects with contraindications to immune checkpoint therapy, as follows:

3. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity

4. Prior organ allograft or allogeneic bone marrow transplantation

5. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication

6. 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

7. Condition requiring systemic treatment with either corticosteroids

• Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are strongly discouraged (see section 5.1.3)

• Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Peter O'Dwyer, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03519308
• Other Study ID Numbers: UPCC 22217
• First Posted: May 8, 2018
• Last Update Posted: Apr 26, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Paclitaxel; Nivolumab

Study Results

No Results Posted as of Apr 26, 2022