Trial results for the Phase 2 study (NCT04090528) investigating pTVG-HP DNA Vaccine with or without pTVG-AR DNA Vaccine and pembrolizumab in patients with castration-resistant, metastatic prostate cancer were posted on ClinicalTrials.gov on 2025-12-05. The study reported a 51% progression-free survival rate for the one DNA vaccine arm and 45% for the two DNA vaccines arm.
Background
The study NCT04090528 evaluated a combination therapy for patients with castration-resistant, metastatic prostate cancer. This approach combines pembrolizumab, a PD-1 blockade agent, with DNA vaccines (pTVG-HP and pTVG-AR) to potentially elicit tumor-directed immune responses.
Trial design
The study NCT04090528 was a Phase 2 trial with an enrollment of 60 participants. It investigated the use of pTVG-HP DNA Vaccine with or without pTVG-AR DNA Vaccine, administered concurrently with pembrolizumab, in patients diagnosed with castration-resistant, metastatic prostate cancer. The trial compared two arms: one receiving a single DNA vaccine (pTVG-HP) with pembrolizumab, and another receiving two DNA vaccines (pTVG-HP and pTVG-AR) with pembrolizumab. Treatment was delivered over a prolonged period, up to 2 years or until radiographic progression.
Key results
The trial reported results for Progression-Free Survival (PFS):
- For Arm 1, which involved one DNA vaccine (pTVG-HP) with pembrolizumab, the progression-free survival was 51% of participants.
- For Arm 2, which involved two DNA vaccines (pTVG-HP and pTVG-AR) with pembrolizumab, the progression-free survival was 45% of participants.
What this means
The posted results provide initial data on the progression-free survival rates for two different DNA vaccine combinations with pembrolizumab in patients with castration-resistant, metastatic prostate cancer. The observed progression-free survival rates of 51% for the one-vaccine arm and 45% for the two-vaccine arm offer insights into the potential efficacy of these immunotherapeutic approaches in this challenging patient population. Further analysis and interpretation of these Phase 2 findings will be important for understanding the role of these vaccine combinations in prostate cancer treatment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04090528, titled "pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer," were posted on 2025-12-05 on clinicaltrials.gov.