Trial results for a Phase 1/2 study investigating ALKS 4230 (Nemvaleukin Alfa) alone and in combination with pembrolizumab in patients with advanced solid tumors were posted on ClinicalTrials.gov on 2025-05-21. The study primarily assessed safety and tolerability, reporting a maximum of 3 dose-limiting toxicities at the 6 mcg/kg dose of Nemvaleukin Alfa.
Background
The study, titled "A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors," aimed to understand the safety and tolerability of ALKS 4230, an investigational agent, both as a monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors.
Trial design
The study (NCT02799095) was a Phase 1/Phase 2 trial that enrolled 243 participants with advanced solid tumors. The trial investigated the effects of ALKS 4230 (Nemvaleukin Alfa) as a monotherapy and in combination with pembrolizumab. The primary objective was to better understand the safety and tolerability of ALKS 4230 in humans.
Key results
The trial's key measurements focused on safety and tolerability outcomes. For Part A, which assessed dose-limiting toxicities (DLTs) based on Common Terminology Criteria for Adverse Events (CTCAE):
- For Nemvaleukin Alfa 0.1 mcg/kg, there were 0 participants with DLTs.
- For Nemvaleukin Alfa 0.3 mcg/kg, there were 0 participants with DLTs.
- For Nemvaleukin Alfa 1 mcg/kg, there were 0 participants with DLTs.
- For Nemvaleukin Alfa 3 mcg/kg, there were 2 participants with DLTs.
- For Nemvaleukin Alfa 6 mcg/kg, there were 3 participants with DLTs.
- For Nemvaleukin Alfa 8 mcg/kg, there were 0 participants with DLTs.
- For Nemvaleukin Alfa 10 mcg/kg, there was 1 participant with DLT.
Regarding treatment-emergent adverse events (TEAEs) across Parts A, B, and C:
- For Nemvaleukin Alfa 0.1 mcg/kg, 5 participants experienced TEAEs.
- For Nemvaleukin Alfa 0.3 mcg/kg, 4 participants experienced TEAEs.
- For Nemvaleukin Alfa 1 mcg/kg, 7 participants experienced TEAEs.
- For Nemvaleukin Alfa 3 mcg/kg, 8 participants experienced TEAEs.
- For Nemvaleukin Alfa 6 mcg/kg, 12 participants experienced TEAEs.
What this means
The results indicate that ALKS 4230 (Nemvaleukin Alfa), both as monotherapy and in combination with pembrolizumab, exhibited dose-dependent patterns in dose-limiting toxicities in patients with advanced solid tumors. The occurrence of DLTs was observed at higher dose levels of Nemvaleukin Alfa, with the highest number of DLTs (3 participants) reported at the 6 mcg/kg dose. These findings are crucial for determining appropriate dosing strategies and further development of ALKS 4230 in oncology settings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02799095, titled "A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors," were posted on 2025-05-21 on clinicaltrials.gov.