DNA Vaccines + Pembrolizumab for Metastatic Prostate Cancer

Palo Alto (17 mi)

Overseen byDouglas McNeel, MD, PhD

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?This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until radiographic progression) on the treatment of castrate-resistant, metastatic prostate cancer. The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a greater frequency and magnitude of tumor-directed CD8+ T cells, and thereby increase the percentage of patients experiencing objective anti-tumor effect as measured by PSA declines and/or objective radiographic responses. Participants must be 18 years of age or older and can expect to be on treatment for 2 years (32 cycles) and on study for up to 7 years (including 5 years of follow up via phone).

Eligibility Criteria

This trial is for adults with castration-resistant, metastatic prostate cancer who have been treated with androgen deprivation. They must be willing to use contraception, have a life expectancy of at least 6 months, an ECOG status of 0-2, no HIV/HTLV-1/hepatitis infections, and adequate organ function. Some will need biopsies and PET/CT scans.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through a tissue examination.

I am currently on standard hormone therapy for my condition.

My cancer has spread to my bones or soft tissues, confirmed by scans.

I can take care of myself and am up and about more than half of my waking hours.

My prostate cancer has worsened despite hormone therapy.

My cancer has not responded to hormone therapy.

Exclusion Criteria

I have had my spleen removed or have an immune system disorder.

My prostate cancer is not the usual type but tests show it has PAP.

I am not on any experimental drugs or cancer treatments other than standard hormone therapy.

I have brain metastases or carcinomatous meningitis.

I haven't had chemotherapy like docetaxel within the last 4 weeks.

I have or had lung inflammation treated with steroids.

I do not have any active cancer except for non-melanoma skin cancer or superficial bladder cancer.

I have an autoimmune disease treated within the last 2 years.

I have been treated with specific immune therapy drugs before.

I have not had external beam radiation in the last 4 weeks and do not expect to need it soon.

I have not taken any prohibited medications in the last 28 days.

I have not had major surgery in the last 4 weeks.

Treatment Details

The study tests if using two DNA vaccines (pTVG-AR and pTVG-HP) with pembrolizumab (PD-1 blockade) increases the anti-tumor effect in patients compared to one vaccine plus pembrolizumab. Treatment lasts up to 2 years with additional follow-up.

2Treatment groups

Experimental Treatment

Group I: Arm 2: Two DNA vaccinesExperimental Treatment3 Interventions

100 µg pTVG-AR administered intradermally (i.d.) on days 1, 8 plus 200 mg Pembrolizumab administered intravenously day 1 of 21-day cycles, for cycles 1, 2, 5, and 6 alternating with 100 µg pTVG-HP administered intradermally (i.d.) on days 1, 8 plus 200 mg Pembrolizumab administered intravenously day 1 of 21-day cycles, for cycles 3, 4, 7, and 8. Following cycle 8, subsequent 21-days cycles: Pembrolizumab 200 mg IV day 1 of 21-day cycles In the event of PSA rise (25% increase over cycle 9 day 1, minimum of 2 ng/ml), and no evidence of radiographic progression, participants will receive 4 additional vaccine booster cycles: 100 µg pTVG-AR i.d days 1, 8 + 200 mg pembrolizumab IV day 1 of q 21-day cycles, for cycles 1 and 2 followed by 100 µg pTVG-HP i.d. days 1, 8 + 200 mg pembrolizumab IV day 1 in 21-day cycles, for cycles 3 and 4

Group II: Arm 1: One DNA vaccineExperimental Treatment2 Interventions

100 µg pTVG-HP administered intradermally (i.d.) days 1, 8 plus 200 mg Pembrolizumab, administered intravenously on day 1 of 21-day cycles (for 8 cycles) Following cycle 8, subsequent 21-days cycles: Pembrolizumab 200 mg IV day 1 of 21-day cycles In the event of PSA rise (25% increase over cycle 9 day 1, minimum of 2 ng/ml), and no evidence of radiographic progression, participants will receive 4 additional vaccine booster cycles: 100 µg pTVG-HP i.d. days 1, 8 + 200 mg pembrolizumab IV day 1 of 21-day cycles x 4 cycles

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: