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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Interventions modified
    • Eligibility criteria expanded, about 147 words
  2. Study sites: 1 to 3
    • Eligibility criteria expanded, about 17 words
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion pushed from Oct 31, 2028 to Jan 31, 2030v8 Show 5 more changesShow less
    • Enrollment increased: 32 → 64 participants
    • Study completion pushed from Mar 31, 2033 to Jun 30, 2034
    • Trial arms changed: 2 → 4
    • Eligibility criteria expanded, about 1,010 words
    • Site contact updated
  5. Enrollment target: 16 to 32v7 Show 4 more changesShow less
    • Primary endpoints revised (6)
    • Eligibility criteria expanded, about 803 words
    • Site contact updated
    • Study arms: 1 to 2
Show 5 earlier versionsHide 5 earlier versions
  1. Study completion date: Sep 30, 2033 to Mar 31, 2033
    • Eligibility criteria shortened, about 123 words
    • Secondary endpoints: details revised at 3 of 3 entries
    v6
  2. Eligibility criteria expanded, about 41 wordsv5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Nov 30, 2028 to Oct 31, 2028
    • Study completion date: Oct 31, 2033 to Sep 30, 2033
    • Start date changed from estimate of Apr 30, 2025 to Mar 20, 2025
    • Site details revised
  4. Start date: Feb 28, 2025 to Apr 30, 2025
    • Primary completion date: Sep 30, 2028 to Nov 30, 2028
    • Study completion date: Aug 31, 2033 to Oct 31, 2033
    v3
  5. Start date: Nov 30, 2024 to Feb 28, 2025v2 Show 6 more changesShow less
    • Primary completion date: Jun 30, 2028 to Sep 30, 2028
    • Study completion date: May 31, 2033 to Aug 31, 2033
    • Interventions: Nivolumab (Biological), Poly ICLC (Drug), Signatera assay (Device), Synthetic long peptide personalized cancer vaccine (Biological) to Poly ICLC (Drug), Signatera assay (Device), Synthetic long peptide personalized cancer vaccine (Biological)
    • Eligibility criteria shortened, about 160 words
    • Secondary endpoints revised (3)
    • Site contact updated
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06529822
Lead Sponsor Washington University School of Medicine
Collaborators: Natera, Inc.
Conditions
(from sponsor)		 Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma, Melanoma, Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Melanoma, Urinary Bladder Neoplasms
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov