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

NCT03519308 | Terminated Early Phase 1 Results DMC FDA Drug

• 1 other identifier: UPCC 22217
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective Response Rate

  3 months

• Progression-free Survival

  1 year

• Proportion of Patients Undergoing Surgery

  3 months

• Overall Survival

  1 year

• Proportion of Margin Negative Surgical Resections

  3 months

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Nivolumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Paricalcitol

Arm B

EXPERIMENTAL

Drug: Nivolumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine

Interventions

Nivolumab DRUG

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

Arm A; Arm B

Nab-Paclitaxel DRUG

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

Arm A; Arm B

Gemcitabine DRUG

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

Arm A; Arm B

Paricalcitol DRUG

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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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• 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
• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Nivolumab; 130-nm albumin-bound paclitaxel; Gemcitabine; paricalcitol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Liudmila Mazaleuskaya/Pancreas Research Program Manager
• Organization: Abramson Cancer Center, University of Pennsylvania

mazali@pennmedicine.upenn.edu

2674559141

Study Officials

• Peter O'Dwyer, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 8, 2018
• Study Start: July 29, 2020
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-03

Locations

US (1)