Actively Recruiting
Phase 1 Clinical Trial of a Personalized Cancer Vaccine Strategy in Patients With Muscle-Invasive Bladder Cancer or Gastroesophageal Adenocarcinoma and Molecular Residual Disease
Led by Washington University School of Medicine ยท Updated on 2026-01-13
32
Participants Needed
1
Research Sites
230 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
Researchers are evaluating a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease in this phase 1 clinical trial. The study aims to assess the safety, feasibility, and immune response generated by synthetic long peptide personalized cancer vaccines combined with poly-ICLC. The hypothesis is that these vaccines can safely produce specific T-cell responses that help clear circulating tumor DNA (ctDNA). Participants will receive the personalized vaccines on a schedule of Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All injections are given intramuscularly and combined with poly-ICLC by healthcare providers. The vaccines target prioritized cancer neoantigens specific to each patient. The study includes cohorts for muscle-invasive bladder cancer and gastroesophageal adenocarcinoma. During the trial, researchers will monitor safety through adverse event tracking from the first vaccine dose to 30 days after the last dose, and assess feasibility by tracking enrollment success and vaccine delivery timelines. Immune responses will be measured by ELISPOT analysis, and ctDNA clearance will be evaluated using the Signatera assay. Recurrence-free survival will also be followed for up to 66 months. Participants will undergo regular imaging, blood tests, and clinical assessments throughout the study.
CONDITIONS
Brief 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 2 or less (Karnofsky 60% or higher)
- Histologically confirmed muscle-invasive bladder cancer or upper tract urothelial carcinoma with dominant transitional cell pattern (Cohort 1)
- Histologically confirmed gastroesophageal adenocarcinoma, stage II or III (Cohort 2)
- Complete surgical resection of tumor with no residual disease confirmed by imaging
- Positive circulating tumor DNA (ctDNA) test by Signatera assay
- Adequate bone marrow and organ function as defined by specific blood counts and liver/kidney function
- Fully recovered from surgery as judged by treating physician
- Willingness to use adequate contraception during the study and for 5 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving or planning to receive other investigational agents outside this protocol
- Known allergy or serious reaction to vaccines such as anaphylaxis, hives, or breathing difficulties
- Psychiatric or social conditions limiting compliance with study requirements
- Prior or active autoimmune diseases requiring immunosuppression, with some exceptions for topical or inhaled steroids
- Pregnant or breastfeeding women
- Known HIV-positive status
- Active hepatitis B or C infection
- Unresolved side effects from prior cancer treatments greater than Grade 1 toxicity
- Prior or concurrent malignancy that may interfere with study assessments
- Live vaccine administered within 30 days prior to enrollment
- Immunodeficiency or systemic immunosuppressive therapy within 30 days prior to enrollment
- Active autoimmune disease excluding diabetes mellitus or vitiligo
- Severe hypersensitivity to checkpoint inhibitors
- Current or history of clinically significant lung disease or pneumonitis
- Active tuberculosis within 3 months prior to treatment initiation
- Women of childbearing potential must have negative pregnancy test within 7 to 14 days before study entry
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive personalized cancer vaccines administered intramuscularly along with Poly ICLC injections on a specific schedule.
10 visits for vaccine administration on Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169
Duration - Up to 66 months
Participants are monitored for safety, immune response, molecular residual disease, and recurrence-free survival after completing treatment.
Regular follow-up visits during this period
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.
R
Russell Pachynski, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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