NCT02885727

Durvalumab Plus "Booster" RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy (GCC 1598)

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Metastatic Pancreas Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Evaluate if 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
RADIATION	Radiation Therapy	The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.

Timeline

• Start date: 2017-07-01
• Primary completion: 2020-12-01
• Completion: 2022-12-01
• First posted: 2016-08-31
• Last updated: 2019-09-12

Regulatory

• FDA-regulated drug study