Actively Recruiting
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
Led by Washington University School of Medicine · Updated on 2026-01-13
32
Participants Needed
1
Research Sites
419 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
Natera, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 2 or less (Karnofsky score 60% or higher)
- Histologically confirmed muscle-invasive bladder cancer or upper tract urothelial carcinoma with dominant transitional cell pattern
- Complete surgical removal of the tumor (R0 resection) with specific TNM classification (pT2-4aN0M0 or pT0-4aN+M0)
- Full recovery from surgery as determined by treating physician
- Positive ctDNA result identified by Signatera assay
- Radiologic confirmation of no residual disease or metastasis
- Adequate bone marrow and organ function including WBC ≥ 1.5 K/cumm, absolute neutrophil count ≥ 1.0 K/cumm, platelets ≥ 50 K/cumm, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5 times upper limit of normal, AST/ALT ≤ 3.0 times upper limit of normal, creatinine clearance > 30 mL/min by Cockcroft-Gault
- Use of adequate contraception by women of childbearing potential and men during study and for 5 months after
- No concurrent investigational therapies outside this protocol
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Receiving or planning to receive other investigational agents as part of neoadjuvant therapy (except perioperative chemotherapy and immunotherapy)
- Known allergy or serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty
- Psychiatric illness or social situations limiting study compliance
- Prior or active autoimmune disease requiring immunosuppression (with some exceptions for inhaled or local steroids)
- Pregnant or breastfeeding
- Known HIV positive status
- Active or chronic hepatitis B or C infection
- Unresolved adverse events from prior anti-cancer therapy above Grade 1 except alopecia
- Prior or concurrent malignancy interfering with safety or efficacy assessment
- Live vaccine administered within 30 days prior to enrollment
- Immunodeficiency or use of systemic steroids or immunosuppressive therapy within 30 days
- Active autoimmune disease excluding diabetes mellitus or vitiligo
- Severe hypersensitivity to checkpoint inhibitors or their excipients
- Current or history of pneumonitis requiring steroids or significant interstitial lung disease
- Active tuberculosis test within 3 months prior to treatment
- Women of childbearing potential must have a negative pregnancy test within 7-14 days of study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
W
William Gillanders, M.D.
CONTACT
R
Russell Pachynski, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here