Last updated on October 2017

Preoperative Pilot Study to Assess Safety and Immunological Effect of Pembrolizumab (Keytruda ) in Combination With Paricalcitol With or Without Chemotherapy in Patients With Resectable Pancreatic Cancer


Brief description of study

The goal of this clinical research is to learn about the safety and tolerability of Keytruda® (pembrolizumab) in combination with paricalcitol, with or without standard chemotherapy in patients who have resectable (can be removed with surgery) pancreatic cancer. In this study, standard chemotherapy is the combination of Gemzar® (gemcitabine) and Abraxane® (nab-paclitaxel). Researchers also want to learn if giving the study drugs before surgery may help to control the disease. The safety of this drug combination will also be studied. This is an investigational study. Pembrolizumab is FDA approved and commercially available for the treatment of melanoma and non-small cell lung cancer. Paricalcitol is FDA approved and commercially available for preventing hyperparathyroidism (a type of hormonal disorder). Gemcitabine and nab-paclitaxel are FDA approved and commercially available for the treatment of many cancers, including pancreatic cancer. It is considered investigational to use the combination of pembrolizumab and paricalcitol, by itself or in combination with standard chemotherapy, to treat pancreatic cancer. The study doctor can explain how the study drugs are designed to work. Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.

Detailed Study Description

Study Groups: If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on when you joined the study. This is done because no one knows if one group is better, the same, or worse than the other. - If you are in Group 1, you will receive pembrolizumab and paricalcitol. - If you are in Group 2, you will receive pembrolizumab, paricalcitol, and standard chemotherapy. The first 3 participants will be enrolled in Group 1. After that, participants will be enrolled into groups in an alternating pattern or as decided by the study doctor until 15 patients total are enrolled per arm. Both you and the study doctor will know to which group you have been assigned. Study Drug Administration: All participants will receive pembrolizumab by vein over about 30 minutes on Days 1 and 22, and paricalcitol by vein over about 15 minutes on Days 1, 8, 15, 22, 29, and 36. If you are in Group 2, you will also receive gemcitabine by vein over about 30 minutes and nab-paclitaxel by vein over about 30-40 minutes, on Days 1, 8, and 15. Length of Treatment: You may be able to receive the study drugs for up to 36 days. You will no longer be able to receive treatment if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Study Visits: On Days 1 and 22: - You will have a physical exam. - Blood (about 7-8 tablespoons) will be drawn for routine and biomarker testing. On Days 8, 15, 29, and 36, blood (about 3 tablespoons) will be drawn for routine tests. End-of-Treatment Visit: Within 1 week after you complete treatment: - You will have a physical exam. - You will have an MRI or CT scan. - Blood (about 6-7 tablespoons) will be drawn for routine and biomarker testing. After treatment, your doctor will decide if you are eligible for surgery. If you are eligible for surgery, you will sign a separate consent document that will describe the surgery procedures and its risks in detail. If you are eligible for surgery, a sample of the tumor that is removed during surgery will be collected and used for research tests to study specific proteins that may be on the surface of the tumor. These tests may help better understand cancer and why it did or did not respond to the study drugs. Follow Up: About 30 days after either surgery or your last dose of drugs (if you did not have surgery): - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine and biomarker testing. Follow-Up: Every 4 months for the first year after your follow-up visit, and then every 6 months for the next 2 years, you will have standard of care imaging and blood draws. The results will be reviewed by the study staff. Your participation in this study will be over after all data has been collected. However, if you start a new anti-cancer treatment or the disease gets worse during follow-up, you will be called every 12 weeks to learn how you are doing. These calls will continue until you withdraw from the study or the study ends.

Clinical Study Identifier: NCT02930902

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The University of Texas MD Anderson Cancer Center
Houston, TX United States
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