NCT04394975

Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer

A Phase III, Randomized, Open-label, Active Controlled, Multicenter Study on Toripalimab Combined With Axitinib Versus Sunitinib Monotheraphy as a First-Line Treatment for Unresectable or Metastatic Renal Cell Carcinoma (RCC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, controlled, multicenter, phase III trial to compare the efficacy and safety of Toripalimab in combination with axitinib to sunitinib monotherapy as a first-line therapy for advanced RCC. Eligible patients will be randomized 1:1 to receive the combination therapy of Toripalimab and axitinib or sunitinib monotherapy.

Conditions

• Primary Disease: Unresectable or Metastatic Renal Cell Carcinoma Focus of the Study:PFS Assessed by IRC Per RECIST 1.1

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Biological : Toripalimab Drug: Axitinib	Biological: Toripalimab, Intravenous infusion Drug: Axitinib, oral tablet
DRUG	sunitinib	Drug: Sunitinib, oral capsule

Timeline

• Start date: 2020-08-20
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2020-05-20
• Last updated: 2025-11-28

Locations

1 site across 1 country: China