pTVG-HP + Nivolumab for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHamid Emamekhoo, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).

Eligibility Criteria

Men over 18 with non-metastatic, PSA-recurrent prostate cancer after surgery and possible radiation therapy. They should have a rising PSA level, be in good physical condition (ECOG score < 2), expect to live at least another year, and have normal blood counts and organ function. No recent immunosuppressants or other cancer treatments are allowed, except certain hormone therapies under specific conditions.

Inclusion Criteria

My blood, kidney, and liver tests are normal.

I am willing to give blood samples for research for up to a year after the study ends.

My prostate cancer has returned, is not spread, and my PSA levels are rising quickly.

+8 more

Exclusion Criteria

My testosterone levels are below 50 ng/dL.

My cancer has spread to my bones or lymph nodes.

I have previously received a DNA vaccine for prostate cancer.

+10 more

Participant Groups

The trial is testing the safety of pTVG-HP, a DNA vaccine targeting prostate acid phosphatase (PAP), combined with Nivolumab, an immune checkpoint inhibitor. The goal is to see if this combination can lower serum Prostate-Specific Antigen (PSA) levels in patients whose prostate cancer has returned but hasn't spread.

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment3 Interventions

* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12 * pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12 * rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: