NCT05733715

Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a randomized, single-center, unblinded, pilot treatment study to evaluate pembrolizumab with or without lenvatinib as neoadjuvant therapy for RCC planned for surgical nephrectomy. Study objectives include the assessment of immunologic and histologic response measures following neoadjuvant therapy and their association with post-operative clinical outcomes. This trial will generate preliminary data on immune pharmacodynamic outcomes and tumor response for neoadjuvant pembrolizumab +/- lenvatinib and is not powered for comparison between the arms. Up to 33 participants will be enrolled to ensure 30 evaluable patients. Patients who receive neoadjuvant therapy and undergo nephrectomy are considered evaluable. The study will consist of 5 phases: 1) Study Screening; 2) Neoadjuvant Systemic Therapy; 3) Surgical Resection; 4) Adjuvant Systemic Pembrolizumab Therapy; and 5) Post-Treatment Follow-up. The total study participant duration, including participant follow-up across all 4 study phases, will be approximately 60 months.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab infusion	100 mg/ 4mL on Day 1 of each 3- or 6- week cycle (one 3 wk cycle; up to eight 6 wk cycles)
DRUG	Lenvatinib tablet	10mg and 4mg daily for 21 days

Timeline

• Start date: 2023-05-03
• Primary completion: 2026-06-01
• Completion: 2028-01-01
• First posted: 2023-02-17
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study