New Reference: Nivolumab and Cabozantinib for Advanced RCC


  • Study

    Open-label, randomised, phase 3 trial (CheckMate 9ER)
    Previously untreated advanced or metastatic clear-cell renal cell carcinoma
    Nivolumab 240 mg/2 weeks plus cabozantinib 40 mg/day (N:323) or sunitinib 50 mg/day, 4 weeks per 6-week cycle (N:328)



  • Efficacy

    mOS:37·7 m vs 34·3 m (HR:0·70 [95% CI 0·55–0·90], p=0·0043)
    mPFS:16·6 m vs 8·3 m (HR 0·56 [95% CI 0·46−0·68], p<0·0001)



  • Safety

    Grade >= 3 AEs: 65% vs 54%
    Grade >=3 AEs: HT 13% vs 12%, palmar–plantar erythrodysaesthesia 8% vs 8%, diarrhoea 7% vs 5%
    Treatment-related serious AEs 22% vs 10%
    One treatment-related death occurred with sunitinib



  • Lancet Oncol. 2022 Jul;23(7):888-898.

    Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial

    http://doi.org/10.1016/S1470-2045(22)00290-X

    Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022