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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03600350 | pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 19 | — | — | Sep 10, 2018 | Dec 1, 2027 | May 9, 2025 | 1 | United States |
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...