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pTVG-HP · 1 trial · 3 indications
The expected 6-months PFS rate in Arm 1 (pTVG-HP DNA vaccine and Pembrolizumab) in this participant population is 20-30%. It is hypothesized that adding pTVG-AR DNA vaccine (Arm 2) will increase the 6-months PFS rate to at least 55%. The 6-month PFS rate will be calculated for each study arm along with the corresponding two-sided 95% confidence interval which will be constructed using the Wilson score method. Participants who withdraw from the study without a progression or death event before the 6-month assessment will be excluded from this analysis. The stratified (by randomization strata) Mantel-Haenszel test will be used to compare the 6-months PFS rates between study arms.
| Arm | Type | Description |
|---|---|---|
| Arm 1: One DNA vaccine | EXPERIMENTAL | 100 µg pTVG-HP administered intradermally (i.d.) days 1, 8 plus 200 mg Pembrolizumab, administered intravenously on day 1 of 21-day cycles (for 8 cycles) Following cycle 8, subsequent 21-days cycles: Pembrolizumab 200 mg IV day 1 of 21-day cycles In the event of PSA rise (25% increase over cycle 9 day 1, minimum of 2 ng/ml), and no evidence of radiographic progression, participants will receive 4 additional vaccine booster cycles: 100 µg pTVG-HP i.d. days 1, 8 + 200 mg pembrolizumab IV day 1 of 21-day cycles x 4 cycles |
| Arm 2: Two DNA vaccines | EXPERIMENTAL | 100 µg pTVG-AR administered intradermally (i.d.) on days 1, 8 plus 200 mg Pembrolizumab administered intravenously day 1 of 21-day cycles, for cycles 1, 2, 5, and 6 alternating with 100 µg pTVG-HP administered intradermally (i.d.) on days 1, 8 plus 200 mg Pembrolizumab administered intravenously day 1 of 21-day cycles, for cycles 3, 4, 7, and 8. Following cycle 8, subsequent 21-days cycles: Pembrolizumab 200 mg IV day 1 of 21-day cycles In the event of PSA rise (25% increase over cycle 9 day 1, minimum of 2 ng/ml), and no evidence of radiographic progression, participants will receive 4 additional vaccine booster cycles: 100 µg pTVG-AR i.d days 1, 8 + 200 mg pembrolizumab IV day 1 of q 21-day cycles, for cycles 1 and 2 followed by 100 µg pTVG-HP i.d. days 1, 8 + 200 mg pembrolizumab IV day 1 in 21-day cycles, for cycles 3 and 4 |
| Name | Type | Description |
|---|---|---|
| pTVG-HP | BIOLOGICAL | pTVG-HP is a plasmid DNA, produced in E. coli, that encodes the complementary deoxyribonucleic acid (cDNA) for human prostatic acid phosphatase (PAP). |
| pTVG-AR | BIOLOGICAL | pTVG-AR is a plasmid DNA |
| Pembrolizumab | DRUG | Pembrolizumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer. |
Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) * Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT of abdomen/pelvis, bone scintigraphy) * Castrate-resistant disease, defined as ...
pTVG-HP is an investigational DNA vaccine being studied for the treatment of castration-resistant, metastatic prostate cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in combination with other agents to assess its safety and efficacy in this patient population.
pTVG-HP is a DNA vaccine designed to target prostate cancer cells. It encodes prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer, to stimulate an immune response against the tumor. This mechanism is being investigated in the context of castration-resistant prostate cancer.
pTVG-HP is being developed by Merck & Company, Inc., a global biopharmaceutical company. Merck is conducting clinical trials to evaluate the drug's potential in treating castration-resistant prostate cancer. The company is responsible for the drug's development and regulatory strategy.
pTVG-HP is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The ongoing Phase 2 trial is assessing its safety and efficacy in patients with castration-resistant, metastatic prostate cancer.
pTVG-HP is being evaluated in a Phase 2 clinical trial with the identifier NCT04090528. This trial is studying pTVG-HP DNA vaccine with or without pTVG-AR DNA vaccine and pembrolizumab in patients with castration-resistant, metastatic prostate cancer. The trial is active but not recruiting, with an enrollment of 60 participants in the United States.
No, pTVG-HP is not the same as pTVG-AR. pTVG-HP is a DNA vaccine targeting prostatic acid phosphatase, while pTVG-AR is a separate DNA vaccine targeting the androgen receptor. In the clinical trial NCT04090528, pTVG-HP is being tested with or without pTVG-AR, along with pembrolizumab, to evaluate their combined effects.