Personalized Cancer Vaccine for Bladder Cancer

Recruiting at 1 trial location

Overseen By Russell Pachynski, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Autoimmune disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new personalized vaccine for individuals with muscle-invasive bladder cancer. The goal is to determine if the vaccine is safe and can help the immune system target cancer cells. Participants will receive several vaccine injections over time. This trial may suit those who have undergone bladder cancer surgery, have no visible cancer remaining, but still have cancer DNA in their blood. Participants should not have any autoimmune diseases or be on strong immune-suppressing medications.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that personalized cancer vaccines, like the one being tested, are usually well-tolerated. Studies have found that these vaccines can trigger an immune response without causing serious side effects. This trial is in Phase 1, focusing primarily on safety testing. Although detailed results from this trial are not yet available, previous patients with similar treatments have generally tolerated the vaccine well. The vaccine is administered with a substance called poly-ICLC, which enhances the immune response. Past studies suggest that this combination is safe, but careful monitoring remains important to identify any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bladder cancer, such as surgery, chemotherapy, and radiation, the Personalized Cancer Vaccine (PCV) offers a tailored approach. This vaccine is unique because it is designed specifically for each patient's cancer, potentially improving its effectiveness. It works by training the immune system to recognize and attack cancer cells, which is different from traditional treatments that target the cancer directly. Researchers are excited about this vaccine because it could lead to more personalized and potentially more effective treatments, offering new hope for patients with muscle-invasive bladder cancer.

What evidence suggests that this personalized cancer vaccine might be an effective treatment for bladder cancer?

Research has shown that personalized cancer vaccines, like the one tested in this trial, hold promise for treating bladder cancer. In one study, eight out of ten patients exhibited stronger immune responses, and those who responded to the treatment lived significantly longer. Vaccines made from peptides, which are small parts of proteins, have also been linked to better survival rates and fewer cancer recurrences in bladder cancer. The personalized vaccine in this trial aims to help the body's immune system target cancer cells more effectively. It uses synthetic peptides from the cancer itself to teach the immune system to recognize and attack cancer cells, potentially eliminating the cancer from the body. ^{1 3 4 6 7}

Who Is on the Research Team?

William E Gillanders, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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

I have a ctDNA report from both a tumor tissue sample and a blood test.

My bladder cancer was completely removed by surgery.

My recent scans show no signs of cancer or spread.

Exclusion Criteria

I do not have any major health issues that could risk my safety in the study.

I have an autoimmune disease treated with immunosuppressants.

Receiving any other investigational agents or planning to receive other investigational agents as part of neoadjuvant therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized cancer vaccines on Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169, co-administered with poly-ICLC

24 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recurrence-free survival and immune response

78 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Cancer Vaccine (PCV)

Trial Overview

The study tests a personalized cancer vaccine made from synthetic peptides tailored to each patient's tumor, given alongside Poly ICLC. It also uses the Signatera assay to monitor response and includes Nivolumab as part of the treatment regimen.

How Is the Trial Designed?

Group I: Cohort 2: Gastroesophageal Adenocarcinoma (GEC) Experimental Treatment 3 Interventions

The schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.

Group II: Cohort 1: Muscle Invasive Bladder Cancer (PCV) Experimental Treatment 3 Interventions

The schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Natera, Inc.

Industry Sponsor

Trials

56

Recruited

50,700+

Published Research Related to This Trial

The personalized peptide vaccine (PPV) was found to be safe and well tolerated in a phase I trial involving 10 patients with advanced urothelial carcinoma, with no major adverse effects reported.

Eight out of ten patients showed increased immune responses, and while clinical outcomes varied, those who responded to the treatment had significantly longer median progression-free survival (21 months) and overall survival (24 months) compared to the overall median survival rates of 3.0 and 8.9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of personalized peptide vaccination for advanced urothelial carcinoma patients who failed treatment with methotrexate, vinblastine, adriamycin and cisplatin. Matsumoto, K., Noguchi, M., Satoh, T., et al.[2016]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06529822

Personalized Cancer Vaccine (PCV) Strategy in Patients ...

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0039606024009024

Identification of tumor-antigen signatures and immune ...

This study aims to explore novel muscle-invasive bladder cancer antigen signatures to identify patients most likely to benefit from vaccination.

3.

withpower.com

withpower.com/trial/personalized-cancer-vaccine-for-bladder-cancer-ee060

Personalized Cancer Vaccine for Bladder Cancer

Eight out of ten patients showed increased immune responses, and while clinical outcomes varied, those who responded to the treatment had significantly longer ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11268260/

Vaccine approaches to treat urothelial cancer - PMC

Several trials have demonstrated promising results with improved survival rates and reduced tumor recurrence in patients affected by UC, treated with peptide- ...

5.

mountsinai.org

mountsinai.org/about/newsroom/2025/mount-sinai-study-advances-understanding-of-personalized-vaccines-for-bladder-cancer

Mount Sinai Study Advances Understanding of ...

In the latest trial, 10 patients with bladder cancer received their own personalized version of PGV001, along with atezolizumab. Each vaccine was carefully ...

6.

ecancer.org

ecancer.org/en/news/26472-study-advances-understanding-of-personalised-vaccines-for-bladder-cancer

Study advances understanding of personalised vaccines ...

"Our findings move the field forward by showing how personalised vaccines like PGV001 can work in bladder cancer," says Dr. Bhardwaj, Ward- ...

7.

bcan.org

bcan.org/clinicaltrials/personalized-cancer-vaccine-pcv-strategy-in-patients-with-solid-tumors-and-molecular-residual-disease/

Personalized Cancer Vaccine (PCV) Strategy in Patients ...

BRIEF SUMMARY. This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients ...