Trial results for the Phase 2 study (NCT04704219) investigating pembrolizumab plus lenvatinib for first-line advanced/metastatic non-clear cell renal cell carcinoma (nccRCC) were posted on ClinicalTrials.gov on 2025-12-03. The combination therapy demonstrated an objective response rate (ORR) of 50.6% and a median overall survival (OS) of 41.5 months in this patient population.
Background
The study aimed to evaluate the potential benefits of combining pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
Trial design
The study (NCT04704219) was a Phase 2, single-arm, open-label study that enrolled 160 participants. It investigated the combination of pembrolizumab and lenvatinib in individuals with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
Key results
The trial reported several key efficacy outcomes for the pembrolizumab plus lenvatinib combination:
- The Objective Response Rate (ORR) was 50.6% (Percentage of participants).
- The median Duration of Response (DOR) was 23.5 months.
- The median Progression Free Survival (PFS) was 17.9 months.
- The median Overall Survival (OS) was 41.5 months.
- The Clinical Benefit Rate (CBR) was 71.5% (Percentage of participants).
- The Disease Control Rate (DCR) was 82.3% (Percentage of Participants).
What this means
The results from this Phase 2 study suggest that the combination of pembrolizumab and lenvatinib shows promising activity in patients with first-line advanced/metastatic non-clear cell renal cell carcinoma. The observed objective response rate, along with favorable median duration of response, progression-free survival, and overall survival, indicates a potential therapeutic benefit for this challenging cancer type. These findings contribute to the understanding of treatment options for nccRCC, where effective therapies are needed.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04704219, titled "Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)," were posted on 2025-12-03 on clinicaltrials.gov.