Study of Pembrolizumab and Lenvatinib for Women 18 and Older with Recurrent or Advanced Vulvar Cancer Not Treatable by Surgery or Radiation

What this Trial Is About

This research aims to evaluate the effectiveness and safety of combining pembrolizumab with lenvatinib in women with vulvar squamous cell carcinoma VSCC that is recurrent, persistent, metastatic, or locally advanced and cannot be treated with surgery or radiation. This phase II, open-label, single-arm study focuses on patients who have limited treatment options due to the advanced nature of their cancer. Participants receive pembrolizumab 400 mg every six weeks along with daily doses of lenvatinib at 20 mg. The study monitors these treatments over time to assess their combined impact on the disease. This trial does not include a comparison group and follows patients through treatment to observe outcomes. During the study, patients undergo regular evaluations including scans to measure tumor response, lab tests, and assessments of quality of life. Researchers track the overall response rate within 24 weeks as the primary outcome and also evaluate disease control, duration of response, survival rates, and safety throughout treatment and up to 40 months. Adverse events and patient-reported outcomes are closely monitored to understand treatment effects and tolerability.

Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy