AzTrials
AzTrials

Prostate CancerPhase 1PGV-ProstateNCT05010200

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

A Phase 1 study testing PGV-001, Poly-ICLC and CDX-301 in people with Prostate Cancer, run by Ashutosh Kumar Tewari at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
PGV-001, Poly-ICLC and CDX-301
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
5 Jan 2022to Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be enrolled a subject must meet the following criteria:
  • The subject must have a histologically proven diagnosis of adenocarcinoma of prostate
  • The subject should have any one of:
  • PSA persistence post surgery (defined as a PSA value that fails to become undetectable) by six weeks post treatment,
  • Biochemical recurrence (defined as a PSA value ≥ 0.2ng/ml),
  • An elevated PSA with a doubling time of > 3 months,
Show all 32Show fewer
  • Or an estimated risk of biochemical recurrence within 5 years of 30% or more as assessed by decipher™ report (decipher score of ≥0.3).
  • 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
  • Written informed consent obtained prior to any study procedure.
  • The subject must be able to provide the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor
  • This requirement may be satisfied by providing an archival tissue sample that has been stored in rna later, flash-frozen, or under other rna/dna preserving conditions from an earlier resection.
  • This requirement may also be satisfied by providing rna/dna sequencing from a CLIA certified genomic sequencing laboratory.
  • 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.
  • The subject may continue hormonal therapy (e.g. Anti-androgens) during the study.
  • Subjects may have a detectable or rising PSA provided there is no radiographic evidence of metastatic disease. For patients with a rising PSA, the doubling time should be >3 months.
  • 9. The subject must have a life expectancy greater than twelve (12) months at the time of screening as assessed by the treating physician.
  • The subject must have a performance status of 0-1 as determined by criteria set forward by the eastern cooperative oncology group243.
  • The subject must have at the time of screening acceptable hematologic, hepatic, and renal function, defined by the following:
  • Absolute neutrophil count > 1000/mm3
  • Platelet count > 50,000/mm3,
  • Creatinine < 2.5 mg/dl,
  • Total bilirubin ≤ 1.5 mg/dl, (except in patients with gilbert syndrome who can have total bilirubin < 3.0 mg/dl)
  • Transaminases < 2 times above the upper limits of the institutional normal.
  • INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage.
  • Adequate venous access (for leukapheresis and blood draws)
  • The subject must be male 18 years of age or older.
  • The subject must be deemed competent to give informed consent.
  • The subject must agree to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant.

Who cannot join

  • Potential subjects who meet any of the following criteria will not be included in the study:
  • The subject has metastatic disease at the time of treatment.
  • Patients with history of AML or tumors with known Flt3 mutations/amplifications.
  • The subject has a history of unrelated neoplastic disease, which has been deemed active within thirty-six (36) months of the screening evaluation, with the exception of the following:
  • Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or squamous cell carcinoma.
  • Subjects with tumors of the prostate with a combined Gleason Score ≤ 7
Show all 21Show fewer
  • Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case-by-case basis with eligibility determined based on discussion with the Principal Investigator.
  • The subject has a prior history of unrelated neoplastic disease and has received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.
  • The subject has a history of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), chronic active hepatitis B or hepatitis C with positive PCR.
  • The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions.
  • The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of:
  • Vitiligo
  • Hypothyroidism
  • The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product.
  • The subject has a history of serious allergic reaction to any substance, resulting in hospitalization or requiring other emergent medical attention.
  • The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness.
  • 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.
  • Previous treatment with therapeutic cancer vaccine of any type
  • The subject is less than eighteen (18) years of age, or otherwise unable to give informed consent due to minor status.
  • The subject is a prisoner, as defined by [45 CFR 46.303(c)].
  • The subject is cognitively impaired, and unable to give informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai (ISMMS)

    New York, New York, 10029

Other trials in United States

About this study

Official title: Phase I, Open-label, Single-center Proof of Concept Study Designed to Test the Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in Combination With CDX-301 in Subjects With a History of Prostate Cancer, in the Adjuvant Setting

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.

Read the detailed description

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.

This study will also assess the capacity of PGV001-based a multi-peptide therapeutic vaccines to produce a robust tumor antigen-specific T lymphocytic response in the peripheral circulation when combined with CDX-301, and it will expand the collective body of knowledge regarding the identification, selection and use of mutation-derived tumor antigens for personalized immunotherapy in prostate cancer patients.

The purpose of the proposed trial will be to assess the following hypothesis:

Mutation-derived tumor antigens (MTA) may arise as a result of somatic non-synonymous variations-including nucleotide substitutions, as well as small insertions and deletions-which occur during tumorigenesis. Somatic mutations may be characterized through the use of high-throughput sequencing technologies, and the resulting sequence data used to identify TSA. Sequence data can inform the design of patient-specific immune-based therapies, which may be capable of inducing quantitative changes in the concentration of circulating antigen-specific T lymphocytes directed against TSA, which may in-turn lead to immune-mediated elimination of residual malignant cells.

Conditions
Prostate Cancer
Being tested
PGV-001, Poly-ICLC, CDX-301
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PGV-001Biological

    personalized genomic peptide vaccine

  • Poly-ICLCBiological

    immune modulator

  • CDX-301Biological

    soluble recombinant human protein to work on stem cell

Study groups in NCT05010200
Study groupRoleWhat they receive
Cohort 1 - Primary treatment cohortExperimentalPatients receive the personalized genomic vaccine (PGV) and Poly-ICLC.
Receives: Biological: PGV-001; Biological: Poly-ICLC
Cohort 2 - Secondary treatment cohortExperimentalPatients receive the personalized genomic vaccine (PGV) and Poly-ICLC, and CDX-301
Receives: Biological: PGV-001; Biological: Poly-ICLC; Biological: CDX-301
Cohort 3 - Expansion treatment cohortExperimentalAn expansion cohort if the treatment of all 3 together has not triggered a safety stopping event.
Receives: Biological: PGV-001; Biological: Poly-ICLC; Biological: CDX-301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .

    Measured: 37 days

  2. Number of adverse events

    Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .

    Measured: 191 days

Secondary outcomes (7)

  1. Change in immune cell subsets

    Changes in immune cell subsets to compare immune responses at baseline to prostate antigens and viruses with immune responses obtained after treatment with the vaccine combination

    Measured: 37 days

  2. Change in immune cell subsets

    Changes in immune cell subsets to compare immune responses at baseline to prostate antigens and viruses with immune responses obtained after treatment with the vaccine combination

    Measured: 191 days

  3. Change in immune cell subsets

    Changes in immune cell subsets to compare immune responses at baseline to prostate antigens and viruses with immune responses obtained after treatment with the vaccine combination

    Measured: 365 days

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

    Change in the frequency of vaccine epitope-specific T lymphocyte populations in post-treatment peripheral blood compared to peripheral blood obtained prior to the start of vaccination.

    Measured: 37 days

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

    Change in the frequency of vaccine epitope-specific T lymphocyte populations in post-treatment peripheral blood compared to peripheral blood obtained prior to the start of vaccination.

    Measured: 191 days

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

    Change in the frequency of vaccine epitope-specific T lymphocyte populations in post-treatment peripheral blood compared to peripheral blood obtained prior to the start of vaccination.

    Measured: 365 days

  7. Radiographic free survival

    Radiographic free survival (RFS) by Kaplan-Meier (KM) method.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start5 Jan 2022
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010200
Sponsor's protocol ID
Study 20-02159
Other IDs
PRMC 20-027
Acronym
PGV-Prostate
Status last verified
Jan 2026
First submitted
18 Jun 2021
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PGV-001, Poly-ICLC and CDX-301 in people with Prostate Cancer, run by Ashutosh Kumar Tewari at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: 37 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05010200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in