Trial results for the combination of pembrolizumab (Keytruda) and cabozantinib in patients with advanced metastatic melanoma were posted on ClinicalTrials.gov on 2025-08-24. The Phase 1/2 study (NCT03957551) reported a median progression-free survival of 6.6 months for the combination therapy.
Background
The study aimed to evaluate the safety and preliminary efficacy of the combination of cabozantinib and pembrolizumab in patients with advanced metastatic melanoma.
Trial design
The study (NCT03957551) was a Phase 1/Phase 2 trial investigating cabozantinib and pembrolizumab for advanced metastatic melanoma. It enrolled 28 participants and was ultimately terminated. The trial's brief summary indicated its aim was to evaluate the safety and preliminary efficacy of the combination.
Key results
The trial reported several key outcomes for the combination of cabozantinib and pembrolizumab:
In Phase 1, dose-limiting toxicities (DLT) were assessed:
- For the 40mg cabozantinib dose group, 1 participant experienced a DLT.
- For the 60mg cabozantinib dose group, 0 participants experienced a DLT.
In Phase 2, efficacy outcomes included:
- The Overall Response Rate was observed in 9 participants.
- The Disease Control Rate was observed in 15 participants.
- The median Progression-Free Survival was 6.6 months (a 95% Confidence Interval was indicated but the specific values were not provided in the data).
- The Overall Survival at 2 Years was a 63 Percent Probability of Survival (a 95% Confidence Interval was indicated but the specific values were not provided in the data).
What this means
The results from this Phase 1/2 study provide initial insights into the safety and efficacy profile of the cabozantinib and pembrolizumab combination in advanced metastatic melanoma. The observed median progression-free survival of 6.6 months and a 2-year overall survival probability of 63% suggest potential clinical activity for this regimen. The safety evaluation in Phase 1 helped identify dose-limiting toxicities, with the 60mg cabozantinib dose showing no DLTs in the evaluated group.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03957551, titled 'Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma,' were posted on 2025-08-24 on clinicaltrials.gov.