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

NCT06529822 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Muscle-Invasive Bladder Carcinoma
  • Gastroesophageal Adenocarcinoma

Interventions

BIOLOGICAL

Synthetic long peptide personalized cancer vaccine

Neoantigen vaccines will be provided on a patient-specific basis

DRUG

Poly ICLC

Poly-ICLC will be supplied by Oncovir, Inc.

DEVICE

Signatera 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

Sponsors & Collaborators

  • Natera, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • William Gillanders, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2028-10-31
Completion
2033-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06529822 on ClinicalTrials.gov