RecruitingPhase 1

Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

United States64 participantsStarted 2025-03-20

Plain-language summary

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Cohort #1: * Age ≥ 18 years. * ECOG performance status ≤ 2 (Karnofsky ≥ 60%). * Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and/or ureter). * Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern. * Complete surgical resection of MIBC (R0) or upper tract urothelial carcinoma (renal pelvis and/or ureter). Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows: pT2-4aN0M0 or pT0-4aN+M0. * Patient must have fully recovered from surgical resection in the opinion of the treating MD. * ctDNA positive result as identified by Signatera. * Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis. * Adequate bone marrow and organ function as defined below: * WBC ≥ 1.5 K/cumm * Absolute neutrophil count ≥ 1.0 K/cumm * Platelets ≥ 50 K/cumm * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Creatinine clearance \> 30 mL/min by Cockcroft-Gault * The effects of synthetic long peptide personalized cancer vaccines and Hiltonol on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the durati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as measured by treatment-emergent adverse events (TEAEs)

Timeframe: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

Safety as measured by treatment-related adverse events (TRAEs)

Timeframe: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

Safety as measured by serious adverse events (SAEs)

Timeframe: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

Feasibility as measured by the success of enrolling patients with molecular residual disease

Timeframe: Through 30 months

Feasibility as measured by the expected time frame for vaccine creation

Timeframe: Through 24 weeks

Feasibility as measured by the rate of successful vaccine delivery

Timeframe: Through 1st vaccine dose (estimated to be 24 weeks)

Trial details

NCT IDNCT06529822

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01-31

Contact for this trial

William Gillanders, M.D.

314-747-0072 gillanders@wustl.edu

View on ClinicalTrials.gov More Muscle-Invasive Bladder Carcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety as measured by treatment-emergent adverse events (TEAEs)

Timeframe: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

Safety as measured by treatment-related adverse events (TRAEs)

Timeframe: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

Safety as measured by serious adverse events (SAEs)

Timeframe: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

Feasibility as measured by the success of enrolling patients with molecular residual disease

Timeframe: Through 30 months

Feasibility as measured by the expected time frame for vaccine creation

Timeframe: Through 24 weeks

Feasibility as measured by the rate of successful vaccine delivery

Timeframe: Through 1st vaccine dose (estimated to be 24 weeks)