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

Phase 3

Active, not recruiting

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

• Registration Number: NCT04394975
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Study Start: 2020-08-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control group	sunitinib	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.

Primary Outcome Measures

Name	Time	Method
PFS assessed by IRC per RECIST 1.1.	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 Outcome Measures

Name	Time	Method
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	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
OS assessed by investigators and IRC per RECIST 1.1, respectively;	3 years	The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using IRC and RECIST 1.1 to determine tumor response;
DOR, assessed by investigators and IRC per RECIST 1.1, respectively;	3 years	The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using IRC and RECIST 1.1 to determine tumor response;
DCR assessed by investigators and IRC per RECIST 1.1, respectively;	3 years	The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using IRC and RECIST 1.1 to determine tumor response;
overall survival rate assessed by investigators and IRC per RECIST 1.1, respectively;	3 years	The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using IRC and RECIST 1.1 to determine tumor response;
PFS assessed by investigators per RECIST 1.1;	3 years	The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using RECIST 1.1 to determine tumor response;
ORR assessed by investigators and IRC per RECIST 1.1, respectively;	3 years	The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using IRC and RECIST 1.1 to determine tumor response;
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	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China