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PD-1 Inhibitor

DNA Vaccines + Pembrolizumab for Metastatic Prostate Cancer

Phase 2

Waitlist Available

Led By Douglas McNeel, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)

All participants must have received (and be receiving) standard of care androgen deprivation treatment

Must not have

Participants who have undergone splenectomy or who have a diagnosis of immunodeficiency

Small cell or other variant (non-adenocarcinoma) prostate cancer histology, unless there is evidence that the tumor expresses PAP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the use of one versus two DNA vaccines to treat prostate cancer that has spread and is no longer responding to hormone therapy. The hypothesis is that delivering two vaccines with a drug that blocks PD-1 will increase the percentage of patients experiencing an anti-tumor effect.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation in organs or skin rashes; infusion reactions; fatigue; liver, kidney or thyroid problems; lung issues such as pneumonitis; and can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer diagnosis was confirmed through a tissue examination.

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I am currently on standard hormone therapy for my condition.

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

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

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My prostate cancer has worsened despite hormone therapy.

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My cancer has not responded to hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have brain metastases or carcinomatous meningitis.

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

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I have or had lung inflammation treated with steroids.

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

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

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I have been treated with specific immune therapy drugs before.

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

Antigen-Specific Th1 Immune Response

Median Duration of PSA and Objective Response

Median Radiographic Progression-Free Survival

+4 more

Other study objectives

AR-specific Antibody Response Following Treatment

Change in Gut Microbial Composition

Correlation of gut microbiota to clinical response

+5 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pTVG-AR

2015

Completed Phase 1

~40

Pembrolizumab

2017

Completed Phase 3

~3150