drugset / Trial / NCT04394975

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

NCT04394975

Phase 3 Completed 421 enrolled Shanghai Junshi Bioscience Co., Ltd.
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-08-20
Primary completion
2024-04-02
Completion
2024-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 5 mg Oral
Comparator Sunitinib Small molecule 50 mg Oral
Subject Toripalimab Monoclonal antibody 240 mg Intravenous