drugset / Trial / NCT04394975
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axitinib | Small molecule | 5 mg | Oral |
| Comparator | Sunitinib | Small molecule | 50 mg | Oral |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |