Trial results for pembrolizumab (Keytruda) in advanced/metastatic acral lentiginous melanoma were posted on ClinicalTrials.gov on 2025-04-18. The Phase 2 study (NCT02875132) reported a Clinical Benefit Rate (CBR) in 4 participants and an Overall Response Rate (ORR) in 1 participant.
Background
This trial investigated pembrolizumab in patients diagnosed with advanced/metastatic acral lentiginous melanoma.
Trial design
The Phase 2 study (NCT02875132) enrolled 9 participants with advanced/metastatic acral lentiginous melanoma. The trial investigated pembrolizumab as an intervention. The study's brief summary indicated an aim to determine the Overall Response Rate (ORR), defined as the rate of complete response (CR) and partial response (PR) as per RECIST 1.1, in biological treatment-naïve patients with acral lentiginous melanoma treated with pembrolizumab.
Key results
Key results from the trial for the pembrolizumab group included:
- The Overall Response Rate (ORR) was observed in 1 participant.
- The Response Duration for this participant was 19 months.
- The Clinical Benefit Rate (CBR) was observed in 4 participants.
- Median Progression-free Survival (PFS) was 3.4 months.
- Median Overall Survival (OS) was 7.6 months.
- No participants showed a response as per the Immune-related Response Criteria (irRC), with 0 participants reported.
- A total of 2 participants experienced adverse events.
What this means
The results from this Phase 2 trial provide initial data on pembrolizumab in patients with advanced/metastatic acral lentiginous melanoma. While the study involved a small number of participants, the observation of a Clinical Benefit Rate in 4 participants and an Overall Response Rate in 1 participant offers preliminary insights into the drug's activity in this specific melanoma subtype. The median Overall Survival of 7.6 months also contributes to the understanding of outcomes in this population. Further research would be needed to confirm these findings.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02875132, titled "Pembrolizumab in Advanced/Metastatic Acral Lentiginous Melanoma," were posted on 2025-04-18 on clinicaltrials.gov.