Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pTVG-HP · 1 trial · 1 indication
Subjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. See Adverse Events Section for full summary of data.
A PSA CR will be defined as the percentage of participants with a serum PSA \<0.2 ng/mL and confirmatory PSA \<0.2 ng/mL at least 4 weeks later, as per Prostate Cancer Working Group 2 (PCWG2) recommendations. To qualify as a PSA CR, there must be no evidence of radiographic progression.
| Arm | Type | Description |
|---|---|---|
| Treatment Group | EXPERIMENTAL | * Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12 * pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12 * rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1. |
| Name | Type | Description |
|---|---|---|
| pTVG-HP | BIOLOGICAL | Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP) |
| Nivolumab | DRUG | Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer. |
| GM-CSF | DRUG | Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells. |
Inclusion Criteria: * Patients must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate * Patients must have undergone radical prostatectomy * Patients must have completed local therapy by surgery and any adjuvant/salvage radiation therapy at least 3 months pri...
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pTVG-HP is an investigational monoclonal antibody being studied for the treatment of prostate cancer. It is currently in Phase 2 clinical development for patients with non-metastatic PSA-recurrent prostate cancer. The drug is being evaluated in combination with nivolumab in a clinical trial.
pTVG-HP is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY. The company is conducting a Phase 2 clinical trial of pTVG-HP in prostate cancer.
pTVG-HP is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants, with a planned enrollment of 19 patients.
pTVG-HP is being studied in a Phase 2 clinical trial with the identifier NCT03600350. The trial is titled 'pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer' and is being conducted in the United States. The study is active but not recruiting.
No, pTVG-HP is not the same as nivolumab. pTVG-HP is the investigational drug being studied, and nivolumab is a separate drug used in combination with pTVG-HP in the clinical trial. The trial is evaluating the combination of pTVG-HP and nivolumab in prostate cancer patients.