RecruitingPhase 2NCT06035224

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)


Sponsor

RenJi Hospital

Enrollment

28 participants

Start Date

Aug 23, 2023

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the combination of cadonilimab (a dual immune checkpoint drug targeting both PD-1 and CTLA-4) and lenvatinib (a targeted therapy blocking tumor blood vessel growth) can help patients with advanced clear cell kidney cancer (renal cell carcinoma) that has progressed after prior immunotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced or metastatic clear cell kidney cancer confirmed by biopsy - Your cancer progressed after a prior immunotherapy-based treatment (second-line only) - You have measurable disease on imaging - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have previously received dual immunotherapy (a combination of two immune checkpoint drugs) - You have an active autoimmune disease or are on systemic steroids/immunosuppressants - You have uncontrolled heart disease - You are allergic to the study drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGAK104(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

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NCT06035224