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ACTIVE NOT RECRUITING
NCT06035224
PHASE2

Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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