CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Durvalumab +2 morebiological
Likely dose
Durvalumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02311361
NCT02311361Phase 2Completed

A Pilot Study of Immune Checkpoint Inhibition (Durvalumab With or Without Tremelimumab) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

National Cancer Institute (NCI)·interventional·Posted Dec 8, 2014·Updated Apr 20, 2021

In Brief

A Phase 2 clinical trial evaluating Durvalumab, Tremelimumab, and 1 other intervention for Pancreatic Neoplasms and 4 related conditions. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 8, 2014
Enrollment StartMar 25, 2015
Primary CompletionOct 23, 2019
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.6 years ago

Interventions

Durvalumabbiological

10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.

Tremelimumabbiological

75 mg IV, every 4 weeks for 16 weeks

Sterostatic body radiation therapy (SBRT)radiation

8 Gray (Gy) x 1; 5Gy x 5