CheckMate 9ER

Clinical question

Does nivolumab plus cabozantinib improve first-line outcomes over sunitinib in advanced clear-cell RCC?

Trial context

Population

651 patients

Intervention

Nivolumab 240 mg IV q2w + cabozantinib 40 mg PO daily; control sunitinib 50 mg PO daily 4 weeks on/2 weeks off.

Comparator

Sunitinib

Primary / key evidence

Median PFS 16.6 vs 8.3 mo; HR 0.51. 12-mo OS 85.7% vs 75.6%; HR death 0.60. ORR 55.7% vs 27.1%.

Absolute Effect

What changes for patients?

Median PFS 16.6 vs 8.3 mo; HR 0.51. 12-mo OS 85.7% vs 75.6%; HR death 0.60. ORR 55.7% vs 27.1%.

NNT/NNH: Not calculated unless a defensible fixed-time event-rate comparison was available in the cited primary analysis; median-survival differences alone are not converted to NNT.

Clinical interpretation

Nivolumab plus cabozantinib improved PFS, OS and response, with patient-reported quality of life favoring the combination.

Limitations / maturity

Interpret the effect in the context of the trial population, endpoint definition, follow-up and treatment era. Subsequent trials and evolving standards may limit direct applicability to contemporary patients.

Primary publication

Choueiri TK et al. N Engl J Med. 2021;384:829–841.

Primary publication / source

← Return to The Absolute Effect

Current-practice context · reviewed 14 October 2026

Where this trial fits now

Nivolumab/cabozantinib remains an established first-line IO–TKI option in advanced clear-cell RCC. The pivotal comparison was against sunitinib, not against other contemporary combinations. In IMDC favorable-risk disease, long-term evidence supports PFS and response benefit but not a clear OS advantage versus sunitinib; discuss alternatives, comorbidity, expected toxicity and patient preference.

EAU RCC disease-management guidance ↗

Targeted freshness note added 14 October 2026; exhaustive guideline reconciliation remains pending.