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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06529822
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Gastroesophageal Adenocarcinoma
  • Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Synthetic long peptide personalized cancer vaccine — BIOLOGICAL
    Neoantigen vaccines will be provided on a patient-specific basis
  • Poly ICLC — DRUG
    Poly-ICLC will be supplied by Oncovir, Inc.
  • Signatera assay — DEVICE
    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

Study Details

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.

Key Dates

Start date
Mar 20, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2028
Completion
Mar 31, 2033

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Muscle Invasive Bladder Cancer (PCV)
    The schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.
  • Experimental: Cohort 2: Gastroesophageal Adenocarcinoma (GEC)
    The schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.

Primary Outcome Measure

Safety as measured by treatment-emergent adverse events (TEAEs) [ Time Frame: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
William Gillanders, M.D.
[email protected]
314-747-0072
William Gillanders, M.D. (PRINCIPAL_INVESTIGATOR)
Melissa Reimers, M.D. (SUB_INVESTIGATOR)
Patrick Grierson, M.D. (SUB_INVESTIGATOR)
Eric Knoche, M.D. (SUB_INVESTIGATOR)
Peter Oppelt, M.D. (SUB_INVESTIGATOR)
Joel Picus, M.D. (SUB_INVESTIGATOR)
Robert Schreiber, Ph.D. (SUB_INVESTIGATOR)
Feng Gao, M.D., Ph.D., MPH (SUB_INVESTIGATOR)
Malachi Griffith, Ph.D. (SUB_INVESTIGATOR)
Obi Griffith, Ph.D. (SUB_INVESTIGATOR)
Ramon Jin, M.D. (SUB_INVESTIGATOR)

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