Randomized Pilot Clinical Trial of Neoadjuvant Pembrolizumab +/- Lenvatinib for High Risk Renal Cell Carcinoma

NCT05733715 EARLY_PHASE1 RECRUITING

This study will evaluate the effect of investigational drugs, pembrolizumab alone or pembrolizumab with lenvatinib, on the immune systems response to kidney cancer when given before and after surgery to remove kidney cancer.

Details

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	30
Start date	2023-05-03
Completion	2028-01

Conditions

• Renal Cell Carcinoma

Interventions

• Pembrolizumab infusion
• Lenvatinib tablet

Primary outcomes

• Change in frequency of progenitor exhausted CD8 T cells (TEX prog) in peripheral blood during neoadjuvant pembrolizumab +/- lenvatinib and in tumor tissue. — Approximately 18-24 months
  We will apply two 32-parameter spectral flow cytometry panels for phenotypic characterization of paired blood and tumor specimens over the course of multiple timepoints during three distinct treatment periods (Figure 1: Study Schema): 1) before and after neoadjuvant pembrolizumab + lenvatinib (Arm A), and pembrolizumab alone (Arm B); 2) the initial post-operative adjuvant pembrolizumab period; and 3) upon any tumor recurrence.

Countries

United States