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Clinical Trial Summary

Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response.

The primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy.

The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.


Clinical Trial Description

This clinical trial will use the combination of ionizing radiation and immunotherapy durvalumab (MEDI4736). It is the investigators hypothesis that this combination of ionizing radiation and immunotherapy is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response. This trial's primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy. The study population includes the metastatic pancreatic adenocarcinoma patients who have progressed through first-line chemotherapy. The number of subjects proposed to complete this study is 55. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02885727
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Withdrawn
Phase Phase 2
Start date July 2017
Completion date December 2022

See also
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Completed NCT03126435 - EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX Phase 3
Recruiting NCT01586611 - A Study to See if hENT1 Testing on Tumour Tissue Can Predict Response to Treatment With Gemcitabine Chemotherapy and if a Different Chemotherapy Called FOLFOX is Better Than Gemcitabine in Metastatic Pancreas Cancer Phase 3
Recruiting NCT04897854 - Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer Phase 3