Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06529822 | Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease | PHASE1 | RECRUITING | 32 | — | — | Mar 20, 2025 | Mar 31, 2033 | Jan 13, 2026 | 1 | United States |
-At least possibly related to vaccine therapy
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
The trial will be feasible if 8 patients with molecular residual disease are enrolled in 30 months
The trial will be feasible if the vaccine is created within 24 weeks from signing of treatment consent to vaccine availability.
The trial will be feasible if at least 50% of patients receive the vaccine
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Muscle Invasive Bladder Cancer (PCV) | EXPERIMENTAL | 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. |
| Cohort 2: Gastroesophageal Adenocarcinoma (GEC) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Synthetic long peptide personalized cancer vaccine | BIOLOGICAL | Neoantigen vaccines will be provided on a patient-specific basis |
| Poly ICLC | DRUG | Poly-ICLC will be supplied by Oncovir, Inc. |
| Signatera assay | DEVICE | Signatera is a clinically validated, personalized, tumor-informed, multiplex-PCR and next-generation sequencing (NGS) based clinical trial assay targeting 16 tumor-specific mutations. It is intended for the detection of ctDNA isolated from anticoagulated peripheral whole blood from post-surgical patients previously diagnosed with localized or advanced solid tumors to aid physician assessment and treatment decision-making, together with other clinical factors |
Inclusion Criteria Cohort #1: * Age ≥ 18 years. * ECOG performance status ≤ 2 (Karnofsky ≥ 60%). * Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and/or ureter). * Patients with carcinomas showing mixed histologies are required to ha...