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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSynthetic long peptide personalized cancer vaccine and Poly ICLC

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Washington University School of Medicine

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Washington University School of Medicine
Interventions being studied: Biological: Synthetic long peptide personalized cancer vaccine; Drug: Poly ICLC; Device: Signatera or Altera testing

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Cohort #1:
Age ≥ 18 years.
ECOG performance status ≤ 2 (Karnofsky ≥ 60%).
Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and/or ureter).
Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern.
Complete surgical resection of MIBC (R0) or upper tract urothelial carcinoma (renal pelvis and/or ureter). Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows: ypT0N0M0, pT2-4N0M0, or pT0-4aN+M0.
Patient must have fully recovered from surgical resection in the opinion of the treating MD.
ctDNA positive result as identified by Signatera.
Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
Adequate bone marrow and organ function as defined below:
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 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Creatinine clearance \> 30 mL/min by Cockcroft-Gault
The effects of synthetic long peptide personalized cancer vaccines and Hiltonol on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
No concurrent investigational therapies outside of this protocol are allowed.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Reasons someone may not be able to joinExclusion criteria

Cohort #1:
Receiving any other investigational agents, or planning to receive other investigational agents as part of neoadjuvant therapy. Patients who have received perioperative neoadjuvant chemotherapy and immunotherapy, including enfortumab vedotin plus pembrolizumab (EV+P), are allowed.
Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \> 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.
Known HIV-positive status.
History of positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia. For treatment enrollment the patient must have completed all prior cancer treatments \> 28 days prior to vaccine administration with the exception of adjuvant SOC immunotherapy.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial per discussion with the PI.
Currently receiving any other investigational agents.
Live vaccine administered within 30 days prior to enrollment.
Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 30 days of enrollment.
Active autoimmune disease (excluding diabetes mellitus and/or vitiligo), solid organ or allogeneic bone marrow transplant, or other known contraindications to receiving immunotherapy.
Severe hypersensitivity (grade ≥ 3) to checkpoint inhibitors and/or any of its excipients.
Current pneumonitis, a history of (non-infectious) pneumonitis requiring steroids, or history of clinically significant interstitial lung disease.
Active tuberculosis test within 3 months prior to treatment initiation.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days of prior to the first dose of vaccine. Inclusion Criteria Cohort #2:
Age ≥ 18 years.
ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
Histologically confirmed gastroesophageal adenocarcinoma
Stage II or III gastroesophageal adenocarcinoma (GEC).
Complete surgical resection of GEC (R0). Full recovery from surgery and enrollment within 3 yearsfollowing surgery with curative intent. Eligible patients must have had clinical tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) documented at initial diagnosis after completion of diagnostic staging and prior to initiation of definitive anti-cancer therapy as follows:
Esophageal and esophagogastric junction adenocarcinoma: cT1 cN1-3 cM0 or cT2-4 cN0-2 cM0
Gastric adenocarcinoma: cT1-2 cN1-3 cM0 or cT3-4 cN0-3 cM0
Patient must have fully recovered from surgical resection in the opinion of the treating MD.
ctDNA positive result as identified by Signatera.
Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
Adequate bone marrow and organ function as defined below:
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 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Creatinine clearance \> 30 mL/min by Cockcroft-Gault
The effects of synthetic long peptide personalized cancer vaccines and Hiltonol and on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
No concurrent investigational therapies outside of this protocol are allowed.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

AdventHealthOrlando, Florida
Washington University School of MedicineSt Louis, Missouri
Ohio State UniversityColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2026. Always confirm current availability with the study team.

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