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

NCT ID: NCT03519308

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2022-04-18

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

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

Nab-Paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Paricalcitol

Intervention Type: DRUG

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

Arm B

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

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

Nab-Paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Interventions

Nivolumab

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

Intervention Type: DRUG

Nab-Paclitaxel

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Paricalcitol

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

Intervention Type: DRUG

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 0-2.
• 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.

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

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:

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

2. Prior organ allograft or allogeneic bone marrow transplantation

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

4. 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

5. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter O'Dwyer, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UPCC 22217

Identifier Type: -

Identifier Source: org_study_id