Trial results for the VAccination in Early and ADvanced Prostate caNCEr study (NCT03815942), which investigated nivolumab in combination with a vaccine for prostate cancer, were posted on ClinicalTrials.gov on 2025-06-25. The Phase 1/Phase 2 study, which was terminated, involved participants with Intermediate Risk Prostate Cancer and Castration-resistant Prostate Cancer.
Background
The VAccination in Early and ADvanced Prostate caNCEr trial explored a combination therapy for prostate cancer. The study utilized nivolumab alongside a chadox1-mva 5t4 vaccine. This vaccine was designed to alert the immune system to the presence of the 5T4 protein, which is found on cancer cells, with the aim of enabling the immune system to target and eliminate these cells. The trial focused on patients with Intermediate Risk Prostate Cancer and Castration-resistant Prostate Cancer.
Trial design
The VAccination in Early and ADvanced Prostate caNCEr study (NCT03815942) was a Phase 1/Phase 2 clinical trial that was terminated. It enrolled 23 participants with Intermediate Risk Prostate Cancer or Castration-resistant Prostate Cancer. The interventions studied were the chadox1-mva 5t4 vaccine and nivolumab infusion [opdivo]. The trial aimed to evaluate various outcomes, including safety, efficacy, and immune responses, but no primary outcomes were explicitly listed in the posted data.
Key results
The posted trial results indicate the number of participants for whom various outcomes were measured, but do not provide specific numerical findings for efficacy, safety, or immune responses. The outcomes evaluated for the Advanced Metastatic Prostate Cancer group, which included 23 participants, were:
- Safety - Incidence of Treatment-related Adverse Events: 23 Participants
- Efficacy - Measure Composite Response Rate Defined as One of the Following: 1) Change in Circulating Tumour DNA 2) Change in Serum PSA: 5 Participants
- Evaluate Immune Responses to the Vaccine Antigen in the Periphery: 23 Participants
- Evaluate Immune Cell Subsets in the Prostate Secondary to Treatment (for Surgical Cohort): 23 Participants
- Evaluate Progression-free Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort): 23 Participants
- Evaluate Overall Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort): 23 Participants
Specific data points, such as adverse event rates, response rates, or survival statistics, were not detailed in the posted results.
What this means
The posting of results for the VAccination in Early and ADvanced Prostate caNCEr study provides transparency regarding its conduct and termination. While the data indicates the types of outcomes that were assessed, the absence of specific numerical results for efficacy, safety, or immune responses means that no conclusions can be drawn about the potential benefits or risks of the nivolumab and vaccine combination from this particular posting. The termination of the study suggests that it did not proceed as initially planned.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03815942, titled "VAccination in Early and ADvanced Prostate caNCEr," were posted on 2025-06-25 on clinicaltrials.gov.