NCT05877820

A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC

A Prospective, Single Arm Clinical Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in the First Line Treatment of Patients With Locally Advanced or Metastastic Fumarate Hydratase Deficient Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. The purpose of this study is to evaluate the efficacy and safety of Lenvatinib in combination with tislelizumab in the first line treatment of patients with locally advanced/metastatic FHRCC.

Conditions

• Fumarate Hydratase Deficient Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Tislelizumab	Intravenous infusion
DRUG	Lenvatinib	Oral tablet

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-05-26
• Last updated: 2023-08-31

Locations

1 site across 1 country: China