Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Synthetic long peptide personalized cancer vaccine · 1 trial · 4 indications
-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. |
| Cohort 3: Melanoma | 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 4: Non-Small Cell Lung Cancer | 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...
The synthetic long peptide personalized cancer vaccine is an investigational therapy being studied for use in muscle-invasive bladder carcinoma, as well as gastroesophageal adenocarcinoma, melanoma, and non-small cell lung cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
Natera, Inc. (NASDAQ: NTRA) is developing the synthetic long peptide personalized cancer vaccine. The company is conducting a Phase 1 clinical trial to evaluate this investigational therapy in patients with solid tumors and molecular residual disease.
The synthetic long peptide personalized cancer vaccine is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA and is still being studied for safety and efficacy in clinical trials.
The synthetic long peptide personalized cancer vaccine is being evaluated in a single Phase 1 clinical trial, NCT06529822, titled "Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease." The trial is recruiting 64 participants in the United States.
Yes, the synthetic long peptide personalized cancer vaccine is referred to as a personalized cancer vaccine (PCV) in clinical trial NCT06529822. The trial is studying this PCV strategy in patients with solid tumors and molecular residual disease.