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NCT02311361 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pancreatic Cancer and Pancreas Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
65
Enrollment target
1
Study location

NCT02311361: Completed Phase 1 study of Pancreatic Cancer and Pancreas Cancer, sponsored by National Cancer Institute (NCI).

NCT02311361 is a Phase 1 study of Pancreatic Cancer and Pancreas Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02311361, a Phase 1 study of Pancreatic Cancer and Pancreas Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target
1
Study location

Study 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 that the drugs being used in this study might work better when combined with SBRT in people with pancreatic cancer. Objective: \- To study the safety and effectiveness of Durvalumab (MEDI4736) and/or tremelimumab with SBRT. Eligibility: \- People 18 and older who have pancreatic cancer that has not responded or 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 or 2 drugs in combination with the SBRT. * For MEDI4736, the duration of each cycle will be 28-days. Participants will get the drug through an intravenous (IV) infusion twice in each cycle (Days 1 and 15). * For tremelimumab, the duration of the first 6 cycles will each last 28 days. Then the duration of the last 3 cycles will change to 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.

Primary Outcome

Adverse Events (AEs) are reported by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1=Mild, Grade 2= Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Fatal.

Conditions Studied

Pancreatic Cancer Pancreas Cancer Pancreatic Neoplasms Cancer of Pancreas Cancer of the Pancreas

Interventions

  • BIOLOGICAL Durvalumab
  • BIOLOGICAL Tremelimumab
  • RADIATION Sterostatic body radiation therapy (SBRT)

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2015-03-25
Est. Completion 2020-12-31
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT02311361 record still lists

NCT02311361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (83% lower).

The record links to 5 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.

NCT02311361 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT02311361 about?

NCT02311361 is a clinical study titled "Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer". 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 that the drugs being used in this study might work better when combined with SBRT in people with pancreatic cancer. Objective: \- T...

What is the current status of trial NCT02311361?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2015-03-25. Estimated completion is 2020-12-31.

What conditions does trial NCT02311361 study?

This clinical trial studies the following conditions: Pancreatic Cancer, Pancreas Cancer, Pancreatic Neoplasms, Cancer of Pancreas, Cancer of the Pancreas.

What interventions are being tested in trial NCT02311361?

The interventions under investigation include: Durvalumab (BIOLOGICAL), Tremelimumab (BIOLOGICAL), Sterostatic body radiation therapy (SBRT) (RADIATION).

Who is sponsoring clinical trial NCT02311361?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02311361 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Pancreatic Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02311361's enrollment target sits among peer trials

65 135th of 278 higher than 143 of 278 other Pancreatic Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02311361, the US trial registry maintained by the National Library of Medicine. NCT02311361 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.