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PD-1 Inhibitor
DNA Vaccines + Pembrolizumab for Metastatic Prostate Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
I am currently on standard hormone therapy for my condition.
Select...
My cancer has spread to my bones or soft tissues, confirmed by scans.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My prostate cancer has worsened despite hormone therapy.
Select...
My cancer has not responded to hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Antigen-Specific Th1 Immune Response
Median Duration of PSA and Objective Response
Median Radiographic Progression-Free Survival
+4 moreOther outcome measures
AR-specific Antibody Response Following Treatment
Change in Gut Microbial Composition
Correlation of gut microbiota to clinical response
+5 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2010
pTVG-HP
2011
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,720 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,870 Patients Enrolled for Prostate Cancer
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,486 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,906 Patients Enrolled for Prostate Cancer
Madison Vaccines, IncUNKNOWN
2 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my spleen removed or have an immune system disorder.I am currently on bisphosphonate therapy but won't start it during the study.My prostate cancer diagnosis was confirmed through a tissue examination.My prostate cancer is not the usual type but tests show it has PAP.I am currently on standard hormone therapy for my condition.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 haven't taken antibiotics in the last month and don't expect to need any in the next month.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.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 finished my last cancer treatment at least 4 weeks ago and have mostly recovered from its side effects.My prostate cancer has worsened despite hormone therapy.My testosterone levels are very low, as confirmed by a recent test.My cancer has not responded to hormone therapy.I have not had external beam radiation in the last 4 weeks and do not expect to need it soon.My prostate cancer is spreading quickly and I've needed more pain medication recently.I have not received a live vaccine in the last 30 days.I have not taken any prohibited medications in the last 28 days.I may or may not have been treated with a specific prostate cancer medication before.I have taken abiraterone or enzalutamide but am now on 5 mg or less of prednisone daily.My blood, kidney, liver, and clotting tests are all within normal ranges.I have not had major surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Two DNA vaccines
- Group 2: Arm 1: One DNA vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA's official stance on Pembrolizumab?
"The Power team rates Pembrolizumab's safety as a 2. While there is some data affirming its safety, there is no evidence demonstrating that it is an effective treatment."
Answered by AI
Are we still enrolling people for this experiment?
"This study is currently seeking participants, as reported on clinicaltrials.gov. The study was initially posted on 10/21/2019 and was most recently edited on 10/17/2022."
Answered by AI
How many people are included in the research project?
"That is accurate, the online clinicaltrial.gov registry reflects that this study is currently recruiting patients. This particular trial was first advertised on October 21st, 2019 and has had a recent update on October 17th, 2022. They are looking for a total of 60 individuals between 2 locations."
Answered by AI
Do the findings of this Pembrolizumab study corroborate with other research?
"City of Hope first studied pembrolizumab in 2010 and, to date, there have been a total of 252 completed trials. There are currently 1000 live trials involving this medication, with many taking place in Saint Louis, Missouri."
Answered by AI
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