Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

Phase 2 Completed 99 enrolled University of Wisconsin, Madison

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.

Timeline

Start: 2011-05-23
Primary completion: 2020-06-30
Completion: 2020-06-30

Outcome

Missed primary endpoint

paper Two-year MFS was not different between study arms (41.8% vaccine v 42.3%; P = .97). PMID 31644357 ↗

registry analysis (other test); GM-CSF Alone vs pTVG-HP Vaccine With GM-CSF; p = 0.97; Mantel Haenszel NCT01341652 ↗

Publications

Results McNeel DG, Eickhoff JC, Johnson LE, Roth AR, Perk TG, Fong L, Antonarakis ES, Wargowski E, Jeraj R, Liu G. Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3507-3517. doi: 10.1200/JCO.19.01701. Epub 2019 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pTVG-HP	Vaccine	100 ug	Intrathecal
Comparator	rhGM-CSF	Protein / enzyme biologic	208 ug	Intrathecal