Lenvatinib and Pembrolizumab before Surgery for the Treatment of Locally Advanced Non-Metastatic Kidney Cancer

Active:	Yes
Cancer Type:	Kidney Cancer Unknown Primary	NCT ID:	NCT04393350
Trial Phases:	Phase II	Protocol IDs:	Winship4955-20 (primary) NCI-2020-01064
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04393350

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 (locally advanced) 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.

Objectives

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. Beginning 7 days after completion of cycle 4, patients undergo kidney surgery. Beginning 4-12 weeks after completion of surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, magnetic resonance imaging (MRI), computed tomography (CT) and multigated acquisition scan (MUGA) or echocardiography throughout study.

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

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