Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02885727
Status:
WITHDRAWN
Last Update Posted:
2019-09-12
First Post:
2016-08-19
Brief Title:
Durvalumab Plus Booster RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy GCC 1598
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase II Trial of in Situ Tumor Vaccination Using Durvalumab and Booster Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding issues caused the study to not be opened the at local IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Panc-DurvalRT
Brief 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
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
Detailed 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 trials 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None