Personalized Cancer Vaccine for Bladder Cancer

Recruiting in Palo Alto (17 mi)

William E. Gillanders, MD - Washington ...

Overseen byWilliam E Gillanders, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

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

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

I am 18 years old or older.

My bladder cancer was completely removed by surgery.

See 11 more

Exclusion Criteria

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

Psychiatric illness or social situations that would limit compliance with study requirements

Known allergy or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty

See 16 more

Treatment Details

Interventions

Personalized Cancer Vaccine (PCV) (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Cohort 1: Muscle Invasive Bladder Cancer (PCV)Experimental Treatment3 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.