RECRUITING

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

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Conditions

Muscle-Invasive Bladder CarcinomaPersonalized cancer vaccineSolid tumorImmunotherapyBladder cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients with Solid Tumors and Molecular Residual Disease

Quick Facts

Study Start:2025-03-20
Study Completion:2033-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06529822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * ECOG performance status ≤ 1 (Karnofsky ≥ 60%).
  3. * Histologically confirmed muscle-invasive bladder cancer (MIBC).
  4. * Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern.
  5. * 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: pT2-4aN0M0 or pT0-4aN+M0. For patients being treated with neoadjuvant chemotherapy who are being considered for inclusion prior to surgery, clinical staging is acceptable.
  6. * Availability of a ctDNA report that is based on tumor tissue specimen and matched blood within 28 days of enrollment.
  7. * Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
  8. * 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.
  1. * Receiving any other investigational agents, or planning to receive other investigational agents as part of neoadjuvant therapy.
  2. * Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
  3. * 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.
  4. * 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.
  5. * Pregnant and/or breastfeeding.
  6. * Known HIV-positive status.
  7. * 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.

Contacts and Locations

Study Contact

William Gillanders, M.D.
CONTACT
314-747-0072
gillanders@wustl.edu
Russell Pachynski, M.D.
CONTACT
314-286-2341
rkpachynski@wustl.edu

Principal Investigator

William Gillanders, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • William Gillanders, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-20
Study Completion Date2033-09-30

Study Record Updates

Study Start Date2025-03-20
Study Completion Date2033-09-30

Terms related to this study

Keywords Provided by Researchers

  • Personalized cancer vaccine
  • Solid tumor
  • Immunotherapy
  • Bladder cancer

Additional Relevant MeSH Terms

  • Muscle-Invasive Bladder Carcinoma