Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
NCT Number: NCT06529822
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Muscle-Invasive Bladder Carcinoma
Interventions: BIOLOGICAL: Synthetic long peptide personalized cancer vaccine|DRUG: Poly ICLC|BIOLOGICAL: Nivolumab|DEVICE: Signatera assay
Sponsor: Washington University School of Medicine
Collaborators: Natera, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-30
Completion Date: 2033-05-31
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

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.

Primary Outcome Measures: Safety as measured by treatment-emergent adverse events (TEAEs), From step 1 enrollment through 30 days following last dose of vaccine (estimated to be 13 months)|Safety as measured by treatment-related adverse events (TRAEs), -At least possibly related to vaccine therapy, From step 1 enrollment through 30 days following last dose of vaccine (estimated to be 13 months)|Safety as measured by serious adverse events (SAEs), As defined in 21 CFR 312.32:

Definition: an adverse event is considered "serious" if, in the view of the investigator, it results in any of the following outcomes:

* Death
* A life-threatening adverse event
* Inpatient hospitalization or prolongation of existing hospitalization
* A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
* A congenital anomaly/birth defect
* Any other important medical event that does not fit the criteria above but, based upon appropriate medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above, From step 1 enrollment through 30 days following last dose of vaccine (estimated to be 13 months)|Feasibility as measured by the success of enrolling patients with molecular residual disease, The trial will be feasible if 16 patients with molecular residual disease are enrolled in 30 months, Through 30 months|Feasibility as measured by the expected time frame for vaccine design and manufacture, The trial will be feasible if the vaccine is designed and manufactured within 24 weeks., Through 24 weeks|Feasibility as measured by the rate of successful vaccine delivery, The trial will be feasible if at least 50% of patients receive the vaccine, Through 1st vaccine dose (estimated to be 24 weeks)
Secondary Outcome Measures: Immune response as measured by ELISPOT analysis, Step 0 enrollment, Step 1 enrollment, day 1, day 15, day 29, day 57, day 85, day 113, day 141, day 169, 1 year (optional), and 2 years (optional), Through 2 years after completion of treatment (estimated to be 3 years)|Molecular residual disease as evaluated by ctDNA clearance using the Signaterra assay, Step 1, day 1, day 8, day 15, day 29, day 57, day 85, day 113, day 141, day 169, and during follow-up., Through completion of follow-up (estimated to be 78 months)|Recurrence-free survival (RFS), Recurrence-free survival is defined as the rate of recurrence from Step 1 enrollment until disease recurrence per standard of care assessments, or until patient is off study, whichever occurs first., Through completion of follow-up (estimated to be 78 months)