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)
Overview
- Phase
- Phase 3
- Intervention
- sunitinib
- Conditions
- Primary Disease: Unresectable or Metastatic Renal Cell Carcinoma Focus of the Study:PFS Assessed by IRC Per RECIST 1.1
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 421
- Locations
- 1
- Primary Endpoint
- PFS assessed by IRC per RECIST 1.1.
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Control group
Sunitinib monotherapy. Participants receive sunitinib 50mg orally once daily for 4 weeks and then are off treatent for 2 weeks, or once daily for 2weeks and then are off treatent for 1 week.
Intervention: sunitinib
Outcomes
Primary Outcomes
PFS assessed by IRC per RECIST 1.1.
Time Frame: 3 years
To compare the progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by independent review committee (IRC) in subjects treated with Toripalimab plus axitinib vesus sunitinib monotherapy as a first-line treatment for advanced RCC.
Secondary Outcomes
- Incidence and grade of AEs and SAEs per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, incidence of ≥ grade 3 AE;(3 years)
- OS assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- DOR, assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- DCR assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- overall survival rate assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- PFS assessed by investigators per RECIST 1.1;(3 years)
- ORR assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- Incidence and grade of AEs and SAEs related to study drugs per NCI-CTCAE version 5.0, AEs ≥ grade 3 related to the study drugs.(3 years)