A Study of Cadonilimab(AK104) Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma
A Single Arm, Phase II Trial of Cadonilimab (AK104) Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
RenJi Hospital
28 participants
Aug 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
AK104 (10mg/kg ,Q3W,intravenously) plus lenvatinib(\<60kg,8 mg qd;≥60kg,12mg qd, orally.
Locations(1)
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NCT06035224