Untreated Metastatic Pancreatic Ductal AdenocarcinomaPhase 2NCT02754726
Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing Nivolumab, Albumin-bound paclitaxel and Paricalcitol in people with Untreated Metastatic Pancreatic Ductal Adenocarcinoma, run by HonorHealth Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Nivolumab, Albumin-bound paclitaxel and Paricalcitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 22 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Nurse Navigator
Scottsdale, Arizona, 85258
About this study
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
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.
- Being tested
- Nivolumab, Albumin-bound paclitaxel, Paricalcitol, Cisplatin, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxelDrug
Also called Abraxane
125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
ParicalcitolDrug
Also called Zemplar
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
CisplatinDrug
Also called Platinol
25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
GemcitabineDrug
Also called Gemzar
1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | open label using combination therapy Receives: Drug: Nivolumab; Drug: Albumin-bound paclitaxel; Drug: Paricalcitol; Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion11 Apr 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Untreated Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute, Bristol-Myers Squibb, Lustgarten Foundation
- Responsible party
- Sponsor
- Investigators
- Erkut Borazanci, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754726
- Sponsor's protocol ID
- NAPPCG-EB 2015-001
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2016
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02754726
- Acronym / sponsor ID
- NAPPCG-EB 2015-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute, Bristol-Myers Squibb, Lustgarten Foundation
- Study start
- Apr 2016 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Drug: Nivolumab, Drug: Albumin-bound paclitaxel, Drug: Paricalcitol, Drug: Cisplatin, Drug: Gemcitabineopen label using combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle | Drug | single arm |
| Albumin-bound paclitaxelAlso: Abraxane125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle | Drug | single arm |
| ParicalcitolAlso: Zemplar25 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 | Drug | single arm |
| CisplatinAlso: Platinol25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle | Drug | single arm |
| GemcitabineAlso: Gemzar1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle | Drug | single arm |
Primary outcome
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 84 months
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.
1 secondary outcome
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 84 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkut Borazanci, MD principal investigator
HonorHealth Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Albumin-bound paclitaxel and Paricalcitol in people with Untreated Metastatic Pancreatic Ductal Adenocarcinoma, run by HonorHealth Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.