2016-04
2023-04-11
2024-03-22
35
NCT02754726
HonorHealth Research Institute
HonorHealth Research Institute
INTERVENTIONAL
Combination Therapy for Patients With 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-04-19 | 2024-06-27 | 2024-12-02 |
2016-04-25 | 2024-12-02 | 2024-12-10 |
2016-04-28 | 2024-12-10 | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: single arm open label using combination therapy | DRUG: Nivolumab
DRUG: Albumin-bound paclitaxel
DRUG: Paricalcitol
DRUG: Cisplatin
DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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