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Cancer Vaccine for Prostate Cancer (PGV-Prostate Trial)

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

PGV-Prostate Trial 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.Check my eligibility

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.See study design

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.

PGV-Prostate Trial 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.

PGV-Prostate Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of adverse events

Secondary outcome measures

Change in immune cell subsets

Change in the frequency of vaccine epitope-specific T lymphocyte populations

Radiographic free survival

PGV-Prostate 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

0 / 10Eligibility criteria met

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

Sujit S Nair, Ph.D.Study DirectorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

13 Total Patients Enrolled

1 Trials studying Prostate Cancer

13 Patients Enrolled for Prostate Cancer

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this clinical trial?

"Affirmative. Evidence on clinicaltrials.gov shows that recruitment for this medical trial is currently active; the study was first published on May 1st 2022 and later modified on August 9th 2022. 27 participants are required to join from one site only."

Answered by AI

What is the potential risk associated with PGV-001?

"PGV-001's safety rating is 1, as there are only limited data points to inform our understanding of its efficacy and security."

Answered by AI

How many participants have signed up for the experiment so far?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is actively recruiting participants, with the initial posting on May 1st 2022 and a recent edit on September 8th 2022. This research requires 27 patients to be enrolled at one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.

Ashutosh Kumar Tewari 2022. "The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010200.