Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Kidney Cancer Clinical Trial

Official title: WINSHIP4955-20: Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

This phase II trial studies how well lenvatinib and pembrolizumab before surgery work in treating patients with kidney cancer that has spread from its original site of growth to nearby tissues or lymph nodes but has not spread to other places in the body (non-metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab before surgery may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To assess the objective response rate (complete and partial responses), following the administration of lenvatinib and pembrolizumab for a total of 4 cycles (12 weeks) in patients with locally-advanced, biopsy-proven non-metastatic clear cell renal cell carcinoma (ccRCC) prior to undergoing nephrectomy (partial or radical).

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of neoadjuvant lenvatinib plus pembrolizumab in a presurgical population as well as the safety of adjuvant pembrolizumab post-surgery.

II. To determine the clinical outcomes including disease-free survival (DFS) and overall survival (OS) of patients with non-metastatic ccRCC treated with neoadjuvant lenvatinib and pembrolizumab and adjuvant pembrolizumab.

III. To evaluate surgery-related complications and outcomes as per the Clavien-Dindo classification system.

EXPLORATORY OBJECTIVES:

I. To evaluate changes in biomarkers of immune activation and gene expression before, during and after treatment.

II. To assess the quality of life, frailty and sarcopenia of patients before and after treatment.

OUTLINE:

Patients receive lenvatinib orally (PO) once daily (QD) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 14 days, then every 12 weeks thereafter. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

• NCT number: NCT04393350
• Study type: Interventional
• Source: Emory University
• Contact: Mehmet A Bilen, MD
• Phone: 404-778-3693
• Email: mehmet.a.bilen@emory.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: June 22, 2020
• Completion date: August 5, 2024