Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT02754726 |
Recruitment Status :
Active, not recruiting
First Posted : April 28, 2016
Last Update Posted : March 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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Untreated Metastatic Pancreatic Ductal Adenocarcinoma | Drug: Nivolumab Drug: Albumin-bound paclitaxel Drug: Paricalcitol Drug: Cisplatin Drug: Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Pilot Trial of Nivolumab + Albumin-Bound Paclitaxel + Paricalcitol + Cisplatin + Gemcitabine (NAPPCG) In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma |
Actual Study Start Date : | April 2016 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | June 2023 |
Arm | Intervention/treatment |
---|---|
single arm
open label using combination therapy
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Drug: Nivolumab
Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Other Name: Opdivo Drug: Albumin-bound paclitaxel 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Other Name: Abraxane Drug: Paricalcitol 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
Other Name: Zemplar Drug: Cisplatin 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Other Name: Platinol Drug: Gemcitabine 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Other Name: Gemzar |
- Complete response rate [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits.When a complete response is documented, a PET scan will be obtained to confirm.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 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 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 PD-1 or PD-L1 therapy.
- Patients taking any chemo or immunosuppressive steroids (equivalent to > 20 mg hydrocortisone per day).
- Patients cannot have > Grade 1 pre-existing peripheral neuropathy (per CTCAE).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754726
United States, Arizona | |
HonorHealth Research Institute | |
Scottsdale, Arizona, United States, 85258 |
Principal Investigator: | Erkut Borazanci, MD | HonorHealth Research Institute |
Responsible Party: | HonorHealth Research Institute |
ClinicalTrials.gov Identifier: | NCT02754726 |
Other Study ID Numbers: |
NAPPCG-EB 2015-001 |
First Posted: | April 28, 2016 Key Record Dates |
Last Update Posted: | March 3, 2022 |
Last Verified: | February 2022 |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gemcitabine Paclitaxel Nivolumab Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors |