drugset

drugset / Trial / NCT02411786

A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF

NCT02411786 ↗

Phase 1 Completed 40 enrolled University of Wisconsin, Madison Madison Vaccines Incorporated · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if a vaccine called pTVG-AR can enhance the participant's immune response against prostate cancer.

Timeline

Start: 2015-08-24
Primary completion: 2019-05-01
Completion: 2020-11-28

Publications

Results Kyriakopoulos CE, Eickhoff JC, Ferrari AC, Schweizer MT, Wargowski E, Olson BM, McNeel DG. Multicenter Phase I Trial of a DNA Vaccine Encoding the Androgen Receptor Ligand-binding Domain (pTVG-AR, MVI-118) in Patients with Metastatic Prostate Cancer. Clin Cancer Res. 2020 Oct 1;26(19):5162-5171. doi: 10.1158/1078-0432.CCR-20-0945. Epub 2020 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pTVG-AR	Vaccine	100 ug	Other
Subject	sargramostim	Protein / enzyme biologic	200 ug	Other

Indications