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PROSTVAC-V · 1 trial · 1 indication
-Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
-MHC tetramers made against the identified neoantigens will be used to evaluate PBMC for neoantigen-reactive T cells
-Laser capture microdissection will be performed to perform genomic studies on specific areas of tissue
-Multiparametric flow cytometry or CyTOF will be performed in parallel to evaluate for any shifts (in quality and quantity) in peripheral leukocyte subsets.
-DLT is defined as any unexpected, treatment-related grade 4 or 5 adverse event that occurs with increased severity or incidence outside of known, expected toxicities, that occur in the first 6 patients enrolled (safety lead-in cohort)
| Arm | Type | Description |
|---|---|---|
| PROSTVAC/Ipilimumab/Nivolumab/Neoantigen DNA vaccine | EXPERIMENTAL | * Within 60 days after the last chemo, patients will start a priming dose of PROSTVAC-V, and subsequent doses of PROSTVAC- F (weeks 0, 2, 5, 8, 11, 14, and 17). During "Treatment A" phase, subjects should receive nivolumab intravenously on Day 1 of each cycle every 3 weeks for 6 doses. Ipilimumab on Day 1 of each cycle every 3 weeks for 2 doses. * Patients will then receive a neoantigen DNA vaccine with continuous nivolumab treatment. The vaccine will be administered starting approximately week 21 by intramuscular injection for a total of 6 treatments every 28 days +/-7 days. Each DNA vaccination will be 4 mg vaccine administered intramuscularly using a TriGrid electroporation device. Patients will receive nivolumab at 480 mg every 28 days concurrently with neoantigen DNA vaccine. This is Treatment B. In the event the DNA vaccine production is delayed, patients will receive single agent nivolumab every 4 weeks beginning week 21 until the vaccine is ready |
| Name | Type | Description |
|---|---|---|
| PROSTVAC-V | BIOLOGICAL | -Replication-competent vaccinia virus which has been engineered to encode the sequences for a modified human prostate-specific antigen (PSA) and a triad of co-stimulatory molecules (TRICOM) |
| PROSTVAC-F | BIOLOGICAL | -Fowlpox virus which does not replicate in human cells and has been engineered to encode the same sequences present in PROSTVAC-V. |
| Nivolumab | DRUG | -Nivolumab is a human monoclonal antibody (mAb) |
| Ipilimumab | DRUG | -Ipilimumab is a mAb blocking the inhibitory signal mediated by cytotoxic T Lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that downregulates the immune system. |
| Neoantigen DNA vaccine | BIOLOGICAL | Each DNA vaccination will be 1 mL vaccine administered intramuscularly. At each vaccination time point, patients will receive two injections at separate sites. |
| TriGrid Delivery System | DEVICE | -Electroporation device |
| Tumor biopsy | PROCEDURE | -Pre-treatment, post-treatment A (optional), and end of treatment |
| Peripheral blood | PROCEDURE | -At the time of pre-treatment biopsy, mid-treatment of chemo-ADT, at time of enrollment (prior to POSTVAC administration), mid-treatment A, mid-treatment B (multiple) |
| Fecal samples | PROCEDURE | -Post chemo/pre-treatment A, post-treatment A, pre-treatment B, post-treatment B |
| Leukapheresis | PROCEDURE | * Post-treatment A/pre-treatment B * Mid-Treatment B, after Cycle 9 Day 1 and prior to Cycle 10 Day 1 * End of treatment |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. * High risk/volume metastatic disease, as defined by 4 or more sites of disease or the presence of visceral metastases. * Must have completed an adequate course of chemo-hormonal, first line therapy for metastatic hormon...
PROSTVAC-V is an investigational therapy being studied for metastatic hormone-sensitive prostate cancer. It is a monoclonal antibody-based treatment that is currently in Phase 1 clinical development. The drug has been evaluated in a completed clinical trial involving 19 patients with this condition.
PROSTVAC-V is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this investigational therapy for metastatic hormone-sensitive prostate cancer. The drug is currently in Phase 1 development.
PROSTVAC-V is in Phase 1 clinical development. It is an investigational therapy for metastatic hormone-sensitive prostate cancer and has not been approved by regulatory authorities. The drug has completed one Phase 1 clinical trial with 19 participants.
PROSTVAC-V has been studied in clinical trial NCT03532217, titled "Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer." This Phase 1 trial was completed in the United States and enrolled 19 male patients aged 18 years and older.
PROSTVAC-V is a specific version of the PROSTVAC therapy. The clinical trial NCT03532217 refers to PROSTVAC as part of the treatment regimen, and PROSTVAC-V is the drug name used in this context. Both names refer to the same investigational therapy being developed for prostate cancer.