Trial results for the Phase 2 study (NCT04393350) investigating perioperative lenvatinib with pembrolizumab in patients with locally advanced nonmetastatic clear cell renal cell carcinoma were posted on ClinicalTrials.gov on 2026-04-20. The study observed an objective response rate of 0.176 (or 17.6%) in the treatment group.

Background

Pembrolizumab (Keytruda) is an immunotherapy drug, while lenvatinib is a kinase inhibitor. This combination was investigated for its potential in treating locally advanced nonmetastatic clear cell renal cell carcinoma.

Trial design

The study (NCT04393350) was a Phase 2 trial, enrolling 18 participants. It investigated perioperative lenvatinib with pembrolizumab in patients diagnosed with Kidney Cancer, specifically Stage III Renal Cell Cancer AJCC v8 and Stage IV Renal Cell Cancer AJCC v8. The trial aimed to study how well this combination works before surgery in treating non-metastatic kidney cancer.

Key results

For the outcome of 'Objective Response Rate (Complete and Partial Responses)' in the 'Treatment (Lenvatinib, Pembrolizumab)' group, the following proportions of participants were reported: 0, 0.176, 0.824, and 0. These are reported as proportions of participants, with 0.176 representing an observed objective response rate.

Regarding the 'Incidence of Adverse Events (AEs)' in the 'Treatment (Lenvatinib, Pembrolizumab)' group, the following numbers of participants were reported: 15, 0, 10, 7, 10, 0, 9, and 0. These figures represent the number of participants experiencing various adverse events.

What this means

The Phase 2 trial results provide initial data on the objective response rate and adverse event incidence for perioperative lenvatinib with pembrolizumab in locally advanced nonmetastatic clear cell renal cell carcinoma. An objective response rate of 0.176 was observed in this small cohort. The reported incidence of adverse events indicates that AEs occurred in several participants, with specific counts ranging from 0 to 15 participants. These findings contribute to understanding the potential activity and safety profile of this combination in this specific patient population.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04393350, titled 'Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma,' were posted on 2026-04-20 on clinicaltrials.gov.