drugset / Trial / NCT03206047

Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT03206047

Phase 1/2 Completed 12 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1401 vaccine may enhance the expression of the genes encoding tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor cells may help the body build an effective immune response to kill tumor cells. Giving atezolizumab, guadecitabine, and CDX-1401 vaccine may work better than CDX-1401 alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Timeline

Start
2017-11-08
Primary completion
2020-11-10
Completion
2020-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody Intravenous
Subject Guadecitabine Oligonucleotide (other) Subcutaneous
Subject Hiltonol Other / unclassified Subcutaneous
Subject RASDEGAFUSP ALFA Vaccine Intravenous