Clinical trial NCT03519308: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Official title: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 18 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 3 months
measure: Progression-free Survival
timeFrame: 1 year
measure: Proportion of Patients Undergoing Surgery
timeFrame: 3 months
measure: Overall Survival
timeFrame: 1 year
measure: Proportion of Margin Negative Surgical Resections
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Peter O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References: