RecruitingPhase 1NCT06529822

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

Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease


Sponsor

Washington University School of Medicine

Enrollment

32 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine approach for patients with bladder cancer or other solid tumors who have had surgery but show signs of residual microscopic disease (cancer that may still be present at a molecular level even though scans look clear). The vaccine is custom-made based on the patient's specific tumor mutations. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with muscle-invasive bladder cancer or upper urinary tract cancer - You have had complete surgical removal of the tumor - There is evidence of residual molecular disease after surgery - Your overall health is acceptable (ECOG ≤ 2) **You may NOT be eligible if...** - Your cancer has visibly spread (metastatic disease on scans) - You have not had complete surgical removal - You have serious immune system disorders - You have received certain prior treatments that would disqualify you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSynthetic long peptide personalized cancer vaccine

Neoantigen vaccines will be provided on a patient-specific basis

DRUGPoly ICLC

Poly-ICLC will be supplied by Oncovir, Inc.

DEVICESignatera assay

Signatera is a clinically validated, personalized, tumor-informed, multiplex-PCR and next-generation sequencing (NGS) based clinical trial assay targeting 16 tumor-specific mutations. It is intended for the detection of ctDNA isolated from anticoagulated peripheral whole blood from post-surgical patients previously diagnosed with localized or advanced solid tumors to aid physician assessment and treatment decision-making, together with other clinical factors


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06529822


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