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Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Sponsor: RenJi Hospital
Summary
This is a phase II, open-label, multicenter, single-arm study evaluating the efficacy and safety of cadonilimab (AK104) in combination with lenvatinib in patients with unresectable advanced or metastatic clear cell renal cell carcinoma (ccRCC) who experienced disease progression during or after prior first-line immunotherapy-based combination therapy. Patients receive cadonilimab plus lenvatinib until radiographic disease progression, unacceptable toxicity, withdrawal of consent, death, or investigator decision. The primary endpoint is objective response rate (ORR) according to RECIST version 1.1 as assessed by investigators.
Official title: A Multicenter, Single-Arm, Phase II Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced/Metastatic Clear Cell Renal Cell Carcinoma Previously Treated With Immunotherapy-Based Combination Therapy
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2023-08-23
Completion Date
2026-10-31
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
AK104(anti-PD-1/CTLA-4 bi-specific antibody ,intravenously),lenvatinib( targeted VEGFR 1-3、FGFR、PDGFRα, small molecule TKI,orally
AK104 (10mg/kg ,Q3W,intravenously) plus lenvatinib(\<60kg,8 mg qd;≥60kg,12mg qd, orally.
Locations (1)
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China