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Cancer Vaccine for Prostate Cancer (PGV-Prostate Trial)

Phase 1
Waitlist Available
Led By Ashutosh Tewari, MD
Research Sponsored by Ashutosh Kumar Tewari
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Before administration of the investigational product, the following time must have elapsed: At least (4) weeks post general anesthesia, At least seventy-two (72) hours post local/epidural anesthesia, The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product. The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product. The subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product.
At the time of treatment, the subjects must have completed radical prostatectomy (rp), all additional s.o.c therapies and be clinically tumor free as defined by s.o.c imaging studies
Must not have
The subject is less than eighteen (18) years of age, or otherwise unable to give informed consent due to minor status.
The subject has been diagnosed and treated at an external facility, and the resulting tissue specimen is of insufficient quality such that it precludes clinical sequencing or any other necessary study procedure, and the subject is unwilling to undergo an additional biopsy procedure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new kind of cancer vaccine in people who have had aggressive prostate cancer. The goal is to see if the vaccine is safe and tolerated.

Who is the study for?
This trial is for men over 18 with a history of aggressive prostate cancer who are currently tumor-free. They must have completed all standard treatments, including surgery and chemotherapy, and not be on any immune-suppressing drugs. Participants need good blood counts and organ function, agree to use contraception if necessary, and provide tissue samples for sequencing.
What is being tested?
The study tests the safety of PGV001-based personalized multi-peptide vaccines combined with CDX-301 in patients who've had aggressive prostate cancer but are now tumor-free. It's designed to see how well they tolerate this new treatment approach after their standard care.
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, allergic responses or other immune-related effects due to vaccine components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had surgery to remove my prostate and am currently cancer-free according to imaging tests.
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I am a man aged 18 or older.
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My blood, liver, and kidney functions are within safe ranges for the trial.
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My PSA levels are high or not dropping as expected after surgery.
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I finished my chemotherapy and any side effects have stabilized or gone away for at least 4 weeks.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have been diagnosed with prostate cancer.
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I have been diagnosed with prostate adenocarcinoma.
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I can provide a tissue sample from my tumor through surgery or biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old or cannot give consent.
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My biopsy from another facility is not good enough for further tests, and I don't want another biopsy.
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I am unable to understand and give consent due to cognitive impairment.
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I have received a cancer vaccine before.
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I have a history of HIV/AIDS or chronic active hepatitis B or C.
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My cancer has spread to other parts of my body.
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I have a history of AML or my tumor has Flt3 mutations.
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I have a history of serious heart, liver, kidney disease, or another chronic illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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
Number of adverse events
Secondary study objectives
Change in immune cell subsets
Change in the frequency of vaccine epitope-specific T lymphocyte populations
Radiographic free survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3 - Expansion treatment cohortExperimental Treatment3 Interventions
An expansion cohort if the treatment of all 3 together has not triggered a safety stopping event.
Group II: Cohort 2 - Secondary treatment cohortExperimental Treatment3 Interventions
Patients receive the personalized genomic vaccine (PGV) and Poly-ICLC, and CDX-301
Group III: Cohort 1 - Primary treatment cohortExperimental Treatment2 Interventions
Patients receive the personalized genomic vaccine (PGV) and Poly-ICLC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-301
2017
Completed Phase 1
~170
Poly-ICLC
2016
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Ashutosh Kumar TewariLead Sponsor
2 Previous Clinical Trials
127 Total Patients Enrolled
1 Trials studying Prostate Cancer
13 Patients Enrolled for Prostate Cancer
Sujit S Nair, PhDStudy DirectorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
15,354 Total Patients Enrolled
Dara Lundon, MD MSc MBA PhDStudy DirectorIcahn School of Medicine at Mount Sinai

Media Library

PGV-001 Clinical Trial Eligibility Overview. Trial Name: NCT05010200 — Phase 1
Prostate Cancer Research Study Groups: Cohort 2 - Secondary treatment cohort, Cohort 1 - Primary treatment cohort, Cohort 3 - Expansion treatment cohort
Prostate Cancer Clinical Trial 2023: PGV-001 Highlights & Side Effects. Trial Name: NCT05010200 — Phase 1
PGV-001 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010200 — Phase 1
~11 spots leftby Jan 2027
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