Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear… (NCT06035224) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma
China28 participantsStarted 2023-08-23
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Written informed consent provided prior to study procedures.
✓. Age ≥18 and ≤80 years at the time of consent.
✓. Histologically or cytologically confirmed renal cell carcinoma with clear cell component.
✓. Unresectable locally advanced or metastatic disease.
✓. Radiographic disease progression during or after prior first-line immunotherapy-based combination therapy for advanced RCC.
✓. At least one measurable lesion according to RECIST v1.1.
✓. ECOG performance status of 0 or 1.
✓. Estimated life expectancy of at least 3 months.
Exclusion criteria
✕. History of hypersensitivity to monoclonal antibodies or any component of cadonilimab or lenvatinib.
✕. Known additional malignancy that is progressing or has required active treatment. Exceptions include adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ.
✕. Prior treatment with dual immune checkpoint blockade, defined as anti-PD-1/PD-L1 combined with anti-CTLA-4 therapy.
✕. Uncontrolled clinically significant cardiovascular disease or symptoms.
✕. Diagnosis of immunodeficiency or receipt of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to first dose.
✕. Active autoimmune disease or history of autoimmune disease that may worsen with immunostimulatory therapy. Subjects with type 1 diabetes mellitus, vitiligo, psoriasis, or hypo-/hyperthyroidism not requiring immunosuppressive treatment are eligible.
✕. History of non-infectious pneumonitis requiring steroids or current pneumonitis/interstitial lung disease.
✕. Active tuberculosis or active syphilitic infection.