Clinical Trials /

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

NCT03519308

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer
  • Official Title: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: UPCC 22217
  • NCT ID: NCT03519308

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
NivolumabArm A
Nab-PaclitaxelArm A
GemcitabineArm A
ParicalcitolArm A

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimental
  • Nivolumab
  • Nab-Paclitaxel
  • Gemcitabine
  • Paricalcitol
Arm BExperimental
  • Nivolumab
  • Nab-Paclitaxel
  • Gemcitabine

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:

               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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Numer of Adverse Events
Time Frame:18 months
Safety Issue:
Description:

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

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