Overview

Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

Status:
Recruiting

Trial end date:
0000-00-00

Target enrollment:

Participant gender:

Summary

Background: - Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving very focused beams of radiation to tumors. Researchers think the drugs used in this study might work better used with SBRT in people with pancreatic cancer. Objective: - To study the safety and effectiveness of MEDI4736 and/or tremelimumab with SBRT. Eligibility: - People 18 and older who have pancreatic cancer that has not responded to chemotherapy. They must be candidates for radiation but not resection. Design: - Participants will be screened with medical history and physical exam. They will have blood tests. Their tumor will be measured using computerized tomography (CT) or magnetic resonance imaging (MRI). - Participants will have their tumor biopsied with a needle. They will have also have a biopsy after cycle 1. - Participants will get 1 of 2 drugs. - MEDI4736 therapy will be given in 28-day cycles. Participants will get the drug through an intravenous (IV) infusion twice in each cycle. - For tremelimumab, therapy for the first 6 cycles will each last 28 days. Then cycles will each last 12 weeks. Participants will get the drug through an IV once in each cycle. - All participants will have SBRT. Some will get 1 dose of radiation and some will get 5. CT scans will map their tumor. - Participants will have medical history, physical exam, and blood tests in each cycle. They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12 months. - Participants will be contacted yearly for follow-up.

Phase:

Phase 1

Details

Lead Sponsor:

National Cancer Institute (NCI)

Treatments:

Antibodies, Monoclonal
Tremelimumab