A Phase II Study of Pembrolizumab Immunotherapy and Lenvatinib in People with Advanced Non-Clear Cell Renal Cell Carcinoma

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Full Title

A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants with First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)

Purpose

The purpose of this study is to assess the safety and effectiveness of combining pembrolizumab immunotherapy and lenvatinib in patients with advanced non-clear cell renal cell carcinoma (a type of kidney cancer) that has not yet been treated. Pembrolizumab enhances the power of the immune system to detect and destroy cancer cells. Lenvatinib blocks enzymes  involved in the growth of cancer cells and the development of new blood vessels that supply these cells. Pembrolizumab is given intravenously (by vein) and lenvatinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic non-clear cell renal cell carcinoma.
  • Patients may not have had prior treatment for advanced disease.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chung-Han Lee at 646-888-5418.

Protocol

21-169

Phase

II

Investigator

Co-Investigators