At a glance
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Efficacy and Safety of First-Line Cadonilimab Plus Axitinib in Patients With Advanced Special Pathological Type Renal Cell Carcinoma: A Prospective, Multi-center, Phase Ib/II Trial
In Brief
A Phase 2 clinical trial evaluating AK104 and Axitinib for Renal Cell Carcinoma and 3 related conditions. Active but no longer recruiting, targeting 37 participants across 1 site.
Detailed Summary
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. Primary objective: Phase Ib: To evaluate the safety and tolerability of different doses of cadonilimab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types to determine the recommended phase II dose (RP2D). Phase II: To evaluate the objective response rate (ORR) of cadonilumab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types according to the RECIST 1.1 criteria.
Study Details
Timeline
Interventions
Anti-PD-1/CTLA-4 bi-specific antibody drug; Phase 1b: 10mg/kg or 15mg/kg; Phase 2: RP2D intravenously (IV)
An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally