Cancer Vaccine for Prostate Cancer

(PGV-Prostate Trial)

Overseen By Monali Fatterpekar

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Ashutosh Kumar Tewari

Must be taking: Anti-androgens

Must not be taking: Immunosuppressants

Disqualifiers: Metastatic disease, HIV/AIDS, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 37 days

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ashutosh Tewari, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Sujit S Nair, Ph.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai

Dara Lundon, MD MSc MBA PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

It has been over 4 weeks since I had general anesthesia and over 72 hours since any local or epidural anesthesia.

I have had surgery to remove my prostate and am currently cancer-free according to imaging tests.

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).

Exclusion Criteria

I am under 18 years old or cannot give consent.

The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product.

My biopsy from another facility is not good enough for further tests, and I don't want another biopsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PGV001-based personalized multi-peptide vaccines in combination with CDX-301

37 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days

Long-term follow-up

Participants are monitored for radiographic free survival

10 years

Treatment Details

Interventions

• CDX-301
• PGV-001
• Poly-ICLC

Trial Overview 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.

Participant Groups

Group I: Cohort 3 - Expansion treatment cohort Experimental Treatment 3 Interventions

An expansion cohort if the treatment of all 3 together has not triggered a safety stopping event.

Group II: Cohort 2 - Secondary treatment cohort Experimental Treatment 3 Interventions

Patients receive the personalized genomic vaccine (PGV) and Poly-ICLC, and CDX-301

Group III: Cohort 1 - Primary treatment cohort Experimental Treatment 2 Interventions

Patients receive the personalized genomic vaccine (PGV) and Poly-ICLC.

Who Is Running the Clinical Trial?

Ashutosh Kumar Tewari

Lead Sponsor

Trials

3

Recruited

150+