Clinical trialPhase 2Withdrawn
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
- Outcome
- Stopped earlyFunding issues caused the study to not be opened the at local IRB (Business decision)
- Phase
- Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- July 2017
- Expected end
- December 2022
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Improvement in median Progression Free Survival using the combination of RT and durvalumab.
- Sponsor
- Other
- Results posted
- No
- Last update
- 12 September 2019
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.