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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03519308
• Other study ID #: UPCC 22217
• Status: Terminated
• Phase: Early Phase 1
• Start date: July 29, 2020
• Est. completion date: April 18, 2022

Study information

• Verified date: March 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Nivolumab
Before Surgery Wks 1 &3, After Surgery Wks 1 &3
• Nab-Paclitaxel
Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery
• Gemcitabine
Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
• Paricalcitol
Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	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.	3 months
Secondary	Progression-free Survival	Proportion of patients alive without progression 1 year from the start of study therapy	1 year
Secondary	Proportion of Patients Undergoing Surgery	Proportion of patients who underwent surgical resection after receiving neoadjuvant therapy	3 months
Secondary	Overall Survival	Overall survival 1 year after the initiation of study therapy	1 year
Secondary	Proportion of Margin Negative Surgical Resections	Proportion of patients undergoing surgical resection with surgical margins uninvolved by tumor	3 months