drugset / Trial / NCT02725489

Pilot Study of Durvalumab and Vigil in Advanced Women's Cancers

NCT02725489

Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this study, the researchers want to learn more about Vigil and durvalumab in advanced women's cancers: 1) how much of Vigil in combination with durvalumab (MEDI4736) can be given with an acceptable level of side effects, 2) the effects of Vigil and durvalumab in combination (good and bad), 3) if Vigil will cause changes in cancer cells that may help durvalumab attack the cancer, and 4) whether or not Vigil and durvalumab will slow your cancer or stop your cancer from getting worse. Combining Vigil with durvalumab will allow the former to induce (or increase) the infiltration of activated T cells into tumors, and in addition, to enhance PD-L1 (programmed cell death ligand 1) expression. Consequently, the response rate of historically low or un-responsive cancer will be increased with the combination of Vigil and anti PD-L1.

Timeline

Start
2016-06-03
Primary completion
2019-12-30
Completion
2020-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Vigil Vaccine 100000 cells Other
Subject Vigil Vaccine 1e+06 cells Other
Subject Vigil Vaccine 1e+07 cells Other