Pembrolizumab and Paricalcitol With or Without Chemotherapy in Patients With Pancreatic Cancer That Can Be Removed by Surgery
NCT02930902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-02-09
Summary
This phase Ib trial studies the side effects and best way to give pembrolizumab and paricalcitol with or without chemotherapy in patients with pancreatic cancer that can be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may find tumor cells and help carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and paricalcitol with or without chemotherapy before surgery may help to control the disease.
Conditions
- Resectable Pancreatic Carcinoma
- Stage I Pancreatic Cancer AJCC v6 and v7
- Stage IA Pancreatic Cancer AJCC v6 and v7
- Stage IB Pancreatic Cancer AJCC v6 and v7
- Stage II Pancreatic Cancer AJCC v6 and v7
- Stage IIA Pancreatic Cancer AJCC v6 and v7
- Stage IIB Pancreatic Cancer AJCC v6 and v7
Interventions
- DRUG
-
Gemcitabine Hydrochloride
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Given IV
- DRUG
-
Paricalcitol
Given IV
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Therapeutic Conventional Surgery
Undergo surgical resection of tumor
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Brandon G Smaglo, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-20
- Primary Completion
- 2023-01-03
- Completion
- 2023-01-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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