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RECRUITING
NCT06035224
PHASE2

A Study of Cadonilimab(AK104) Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

This is a Phase II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with lenvatinib in previous immunotherapy treated advanced/metastatic clear cell renal cell carcinoma (ccRCC). Subjects with unresectable advanced clear cell renal cell carcinoma (ccRCC) who were second line patients after first-line immunotherapy combined treatment progression. Subjects will receive Cadonilimab(AK104) plus lenvatinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators.

Official title: A Single Arm, Phase II Trial of Cadonilimab (AK104) Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2023-08-23

Completion Date

2026-10-31

Last Updated

2024-12-18

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