Trial results for a Phase 1 study (NCT03636477) investigating Nivolumab in combination with Ad-RTS-hIL-12 and veledimex for subjects with glioblastoma were posted on ClinicalTrials.gov on 2025-08-12. The study reported adverse events in 3 to 15 participants across different dose level groups.
Background
Nivolumab (Opdivo) is an antibody that is being investigated for its potential to enable the body's immune system to act against tumor cells. It is currently FDA approved in the United States for indications such as melanoma and non-small cell lung cancer. This study specifically explored its use in subjects with glioblastoma, a type of brain cancer.
Trial design
The study (NCT03636477) was a Phase 1 trial titled "A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102." It enrolled 21 participants with glioblastoma. The trial investigated the combination of Ad-RTS-hIL-12 with veledimex and Nivolumab. The interventions included different dose levels of veledimex (10mg or 20mg) combined with Nivolumab (1mg/kg or 3mg/kg).
Key results
The key results focused on the number of participants experiencing adverse events (AEs) across the different treatment groups:
- In the group receiving Veledimex 10mg Dose Level + Nivolumab 1mg/kg, the number of participants with AEs was reported as 3, 1, 3, and 2 across different reporting instances for this outcome.
- For the Veledimex 10mg Dose Level + Nivolumab 3mg/kg group, the number of participants with AEs was reported as 3, 2, 3, and 2.
- In the Veledimex 20mg Dose Level + Nivolumab 3mg/kg group, the number of participants with AEs was reported as 15, 6, 11, and 4.
What this means
As a Phase 1 study, the primary objective was to assess safety and tolerability of the investigational combination in subjects with glioblastoma. The reported adverse event data provides initial insights into the safety profile of Ad-RTS-hIL-12 with veledimex in combination with Nivolumab at various dose levels. These findings are crucial for informing potential future development and dose selection for subsequent clinical trial phases.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03636477, titled "A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102," were posted on 2025-08-12 on clinicaltrials.gov.