Trials / Recruiting
RecruitingNCT06529822
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-03-20
- Primary completion
- 2028-10-31
- Completion
- 2033-03-31
- First posted
- 2024-07-31
- Last updated
- 2026-01-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06529822. Inclusion in this directory is not an endorsement.