Trial results comparing subcutaneous and intravenous administration of Nivolumab in melanoma participants were posted on ClinicalTrials.gov on 2025-02-27. The study assessed safety and tolerability, reporting 6 participants in the subcutaneous arm and 8 participants in the intravenous arm experienced adverse events in one measurement.
Background
The trial focused on melanoma, specifically in participants with completely resected Stage IIIA/B/C/D or Stage IV disease. Nivolumab is a drug being studied for this condition.
Trial design
This completed Phase 3 study (NCT05297565) enrolled 14 participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma. The trial's purpose was to assess the safety and tolerability of nivolumab administered subcutaneously (using nivolumab/rhuph20 in Arm A) versus intravenously (using nivolumab in Arm B).
Key results
The trial evaluated the number of participants experiencing adverse events (AEs) and serious adverse events (SAEs).
- For the outcome "Number of Participants With Adverse Events":
- In one measurement, 6 participants in Arm A (subcutaneous nivolumab) and 8 participants in Arm B (intravenous nivolumab) experienced adverse events.
- In another measurement, 0 participants in Arm A and 2 participants in Arm B experienced adverse events.
- In a third measurement, 0 participants in Arm A and 0 participants in Arm B experienced adverse events.
- For the outcome "Number of Participants With Serious Adverse Events":
- Across all reported measurements, 0 participants in Arm A (subcutaneous nivolumab) and 0 participants in Arm B (intravenous nivolumab) experienced serious adverse events.
What this means
This Phase 3 study, with an enrollment of 14 participants, offers initial safety and tolerability data for subcutaneous versus intravenous administration of nivolumab in resected melanoma. The reported adverse event numbers, including 6 participants in the subcutaneous arm and 8 participants in the intravenous arm in one measurement, along with 0 serious adverse events in either arm, contribute to the overall safety assessment of these administration routes. Given the small sample size, these findings provide preliminary insights into the safety profiles.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05297565, titled "A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection," were posted on 2025-02-27 on clinicaltrials.gov.