Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

NCT02754726 | Completed Phase 2 Results DMC

• 1 other identifier: NAPPCG-EB 2015-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if the study drugs nivolumab, albumin- bound paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective when combined to treat advanced pancreatic cancer.

Conditions

Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm.

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months

Secondary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months

Study Arms (1)

single arm

OTHER

open label using combination therapy

Drug: Nivolumab; Drug: Albumin-bound paclitaxel; Drug: Paricalcitol; Drug: Cisplatin; Drug: Gemcitabine

Interventions

Nivolumab DRUG

Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle

Also known as: Opdivo

single arm

Albumin-bound paclitaxel DRUG

125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

Also known as: Abraxane

single arm

Paricalcitol DRUG

25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle

Also known as: Zemplar

single arm

Cisplatin DRUG

25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

Also known as: Platinol

single arm

Gemcitabine DRUG

1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

Also known as: Gemzar

single arm

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years of age .
• Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
• Capable of providing informed consent and complying with Trial procedures.
• Karnofsky Performance Status (KPS) of ≥ 70%.
• Life expectancy ≥ 12 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.
• Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.

You may not qualify if:

• Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU (5-Fluorouracil) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
• Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
• Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
• Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
• History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
• Laboratory values: Screening serum creatinine \> upper limit of normal (ULN); total bilirubin \> (ULN); alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≥ 2.5 ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<27% for females or \<30% for males, or coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \>1.5×ULN unless on therapeutic doses of warfarin.
• Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
• History of HIV infection or active or chronic hepatitis B or C.
• Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
• Major surgery within 4 weeks prior to initiation of study treatment.
• Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the patient's participation in the study.
• Patient has a transplanted organ.
• Patients with a history of autoimmune disease.
• Prior Programmed cell death protein-1 (PD-1) or Programmed death-ligand-1 (PD-L1) therapy.

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• Translational Genomics Research Institute: collaborator
• Bristol-Myers Squibb: collaborator
• Lustgarten Foundation: collaborator

Study Sites (1)

Clinical Trials Nurse Navigator

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Interventions

Nivolumab; Albumin-Bound Paclitaxel; paricalcitol; Cisplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Erkut Borazanci, MD MS
• Organization: HonorHealth Research Institute

clinicaltrials@honorhealth.com

4803231350

Study Officials

• Erkut Borazanci, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: April 11, 2023
• Study Completion: March 22, 2024
• Last Updated: August 27, 2025
• Results First Posted: December 10, 2024

Record last verified: 2025-08

Locations

US (1)