A Study of AK104 Plus Axitinib in Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Status:
Not yet recruiting
Trial end date:
2024-08-31
Target enrollment:
Participant gender:
Summary
This is a Phase 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 clear cell
renal cell carcinoma (ccRCC). Subjects with unresectable advanced clear cell renal cell
carcinoma (ccRCC) who had not received systemic therapy for advanced disease will be enrolled
in this trial which is divided with safety run-in phase followed by expansion phase. 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. The
primary endpoint is ORR per RECIST v1.1 as assessed by investigators.