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Poster Display session 3

3142 - 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


30 Sep 2019


Poster Display session 3


Tumour Site

Prostate Cancer


Douglas McNeel


Annals of Oncology (2019) 30 (suppl_5): v325-v355. 10.1093/annonc/mdz248


D.G. McNeel1, B. Saraiya2, M. Schweizer3, J. Eickhoff4, E. Wargowski5, R. Lesniewski6, B. Olson7, C. Kyriakopoulos8

Author affiliations

  • 1 Medicine / Hematology-oncology, University of Wisconsin-Madison, 53705 - Madison/US
  • 2 Medicine, Rutgers Cancer Institute of New Jersey, 08901 - New Brunswick, NJ/US
  • 3 Medicine, Seattle Cancer Care Alliance, 98109 - Seattle/US
  • 4 Biostatistics, University of Wisconsin-Madison, 53726 - Madison/US
  • 5 Medicine, University of Wisconsin-Madison, 53705 - Madison/US
  • 6 Ceo, Madison Vaccines, Inc, 53719 - Madison/US
  • 7 Medicine, Emory University, Atlanta/US
  • 8 Medicine / Hematology-oncologye, University of Wisconsin-Madison, 53705 - Madison/US


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Abstract 3142


Preclinical studies have demonstrated that a DNA vaccine encoding the androgen receptor ligand-binding domain (AR LBD) can elicit CD8+ T cells specific for the AR LBD, delay disease progression and prolong survival of prostate tumor-bearing animals. Vaccination of tumor-bearing mice treated with androgen deprivation (AD) led to a delay in the emergence of castration-resistant disease. This same DNA vaccine (pTVG-AR, MVI-118) was evaluated in a phase I clinical trial in men with metastatic prostate cancer (mPC) on AD therapy.


40 patients with mPC, within 6 months of beginning standard AD therapy, were randomly assigned to receive pTVG-AR on one of two different treatment schedules, and with or without GM-CSF used as an adjuvant. Ten total vaccinations were given over 1 year, and patients were followed for 18 months. The primary objectives were safety and immune activity. Secondary objectives were to evaluate different schedules, the requirement for GM-CSF, and whether treatment was associated with PSA progression-free survival (PSA PFS).


Between 2015 and 2017, 40 patients were enrolled at 3 centers. 27 patients completed treatment and 18 months of follow-up. Eleven patients (28%) had a PSA progression event. No grade 3 or 4 adverse events were observed. Samples from 30 patients were available for immune analysis. 14/30 (47%) developed Th1 biased immunity to the AR LBD as determined by IFNγ or granzyme B ELISPOT that was detectable at least twice after beginning treatment. Differences in immune responses were observed with different schedules, but not with GM-CSF adjuvant. Patients who developed immunity had a significantly prolonged PSA PFS compared to patients without immunity (HR = 0.18, 95% CI: 0.04-0.92, p = 0.040).


This trial showed that pTVG-AR was safe and immunologically active in patients with mPC, and identified a preferred schedule of administration. Association between immunity and PSA PFS suggests treatment may delay the time to castration resistance, similar to observations in preclinical studies. Future studies will evaluate pTVG-AR in earlier stages of disease, and in combination with other agents.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Douglas McNeel.


Madison Vaccines, Inc.


D.G. McNeel: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Licensing / Royalties, Officer / Board of Directors: Madison Vaccines Inc; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Merck. R. Lesniewski: Leadership role, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment, Officer / Board of Directors: Madison Vaccines Inc. B. Olson: Licensing / Royalties: Madison Vaccines Inc. C. Kyriakopoulos: Research grant / Funding (institution): Madison Vaccines Inc. All other authors have declared no conflicts of interest.

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