Trial results for a Phase 2 study evaluating pembrolizumab and lenvatinib in patients with brain metastases from melanoma or renal cell carcinoma were posted on ClinicalTrials.gov on 2026-06-04. The study was terminated, with 0 participants in both the melanoma and renal cell carcinoma cohorts achieving a best brain metastasis response.
Background
The study investigated the combination of pembrolizumab (Keytruda) and lenvatinib in patients with brain metastases. This trial focused on patients with melanoma or renal cell carcinoma who had previously received anti-PD-1/PD-L1 therapy and had untreated brain metastases.
Trial design
The terminated Phase 2 study (NCT04955743) enrolled 18 participants. It was designed as a Simon's 2-stage study with two cohorts: one for patients with melanoma and another for patients with renal cell carcinoma (RCC). Both cohorts included anti-PD-1/PD-L1 experienced patients with untreated brain metastases. The interventions studied were pembrolizumab and lenvatinib.
Key results
The trial reported the following key measurements:
- For Best Brain Metastasis Response Rate (BMRR):
- Cohort 1 (Melanoma): 0 participants
- Cohort 2 (Renal Cell Carcinoma): 0 participants
- For Best Overall Objective Response Rate:
- Cohort 1 (Melanoma): 4 participants
- Cohort 2 (Renal Cell Carcinoma): 2 participants
What this means
The termination of this Phase 2 study, coupled with the reported 0 participants achieving a best brain metastasis response in either cohort, suggests that the combination of pembrolizumab and lenvatinib did not demonstrate sufficient intracranial efficacy in this specific patient population. While 4 participants in the melanoma cohort and 2 participants in the renal cell carcinoma cohort showed a best overall objective response, the lack of brain metastasis responses indicates a potential limitation for treating intracranial disease with this regimen in previously treated patients. Clinicians and researchers should consider these findings when evaluating treatment strategies for brain metastases in melanoma and renal cell carcinoma patients who have prior PD-1/PD-L1 experience.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04955743, titled "Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma", were posted on 2026-06-04 on clinicaltrials.gov.