Trial results for the Phase 2 study (NCT05308901) investigating lenvatinib plus pembrolizumab in patients with immune checkpoint inhibitor-naïve metastatic uveal melanoma were posted on ClinicalTrials.gov on 2025-07-25. The study reported a mean progression-free survival of 165 days and a mean overall survival of 287 days.
Background
The study aimed to evaluate the efficacy of the combination of lenvatinib and pembrolizumab for treating metastatic uveal melanoma. Metastatic uveal melanoma is a rare and aggressive form of melanoma that originates in the eye.
Trial design
The study (NCT05308901) was a Phase 2 trial that enrolled 6 participants with immune checkpoint inhibitor-naïve metastatic uveal melanoma. The intervention involved treatment with pembrolizumab plus lenvatinib. The study's purpose was to evaluate the effect of this combination on progression-free survival, objective response rate, and overall survival.
Key results
The trial results for the Pembrolizumab + Lenvatinib group reported the following:
- The mean progression-free survival was 165 days.
- The mean overall survival was 287 days.
- For the objective response rate, various counts of participants were reported: 0 participants, 3 participants, and 1 participant.
What this means
The results from this Phase 2 trial provide initial data on the combination of lenvatinib and pembrolizumab in patients with immune checkpoint inhibitor-naïve metastatic uveal melanoma. With a small enrollment of 6 participants, the study reported a mean progression-free survival of 165 days and a mean overall survival of 287 days. The objective response rate data included various participant counts, suggesting a complex picture of response in this aggressive cancer. These findings contribute to the understanding of potential therapeutic strategies for this challenging patient population and may guide further research.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05308901, titled "Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma," were posted on 2025-07-25 on clinicaltrials.gov.