Personalized Cancer Vaccine for Bladder Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or systemic steroids, you may need to stop them 30 days before enrolling. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the Personalized Cancer Vaccine (PCV) treatment for bladder cancer?
Research suggests that personalized peptide vaccines can boost the immune system's ability to fight bladder cancer, especially in patients who have not responded well to other treatments. Additionally, combining cancer vaccines with other therapies, like BCG, has shown increased immune responses and tumor regression in bladder cancer models.12345
Is the personalized cancer vaccine safe for humans?
How is the Personalized Cancer Vaccine treatment different from other bladder cancer treatments?
The Personalized Cancer Vaccine (PCV) is unique because it is tailored to each patient's specific cancer profile, aiming to boost the body's immune response against the cancer. Unlike standard treatments, which are the same for all patients, this vaccine selects specific peptides (small proteins) that are most likely to trigger an immune response in the individual, potentially offering a more targeted and effective approach.12489
What is the purpose of this trial?
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.
Research Team
William E Gillanders, M.D.
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for patients with solid tumors, specifically bladder cancer, who have tiny amounts of cancer left after treatment (molecular residual disease). Participants should be adults with a good performance status and must not have autoimmune diseases or be on immunosuppressive medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive personalized cancer vaccines on Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169, co-administered with poly-ICLC
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recurrence-free survival and immune response
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Personalized Cancer Vaccine (PCV)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Natera, Inc.
Industry Sponsor