Camrelizumab plus apatinib for immune checkpoint inhibitor-naive patients with metastatic clear cell renal cell carcinoma after first-line tyrosine kinase inhibitor treatment failure: a single-arm phase 2 trial.

[BACKGROUND] In the immunotherapy era, tyrosine kinase inhibitor (TKI) monotherapy is still commonly used for patients with metastatic renal cell carcinoma (RCC) in clinical practice. Prospective evidence on immunotherapy plus tyrosine kinase inhibitor (TKI) after first-line TKI treatment failure is scarce. This study evaluated the efficacy and safety of camrelizumab plus apatinib in this setting.

[METHODS] In this single-arm, two-center phase 2 study, patients with metastatic clear cell RCC who had failed first-line TKI treatment were enrolled. Camrelizumab 200 mg once every 2 weeks and apatinib 250 mg once daily were continuously administered until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS).

[RESULTS] Between August 2020 and January 2024, 41 patients were enrolled and treated. Median age was 57.0 years (range, 36-81), and 34 (82.9%) patients were males. By the data cutoff date on December 31, 2024, the median follow-up duration was 19.0 months (range, 3.4-49.4). Median PFS was 11.6 months (95% confidence interval [CI], 6.2-18.5), and the median overall survival was not reached. The objective response rate was 41.5% (95% CI, 26.3%-57.9%). The most common grade 3-4 treatment-related adverse events were increased alanine aminotransferase (11 [26.8%]), increased aspartate aminotransferase (nine [22.0%]), and proteinuria (nine [22.0%]). No treatment-related deaths occurred.

[CONCLUSIONS] Our findings suggest the potential of camrelizumab plus apatinib in patients with immunotherapy-naïve metastatic RCC after first-line TKI treatment failure, warranting further investigation.

[TRIAL REGISTRATION] ChiCTR.org.cn, ChiCTR2000034384. Registered on July 4, 2020.