# CheckMate 9ER

Source: https://onco.cc/trials/checkmate-9er/  
OnCo record `checkmate-9er` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Nivolumab with cabozantinib doubled progression-free survival versus sunitinib and lengthened life, with quality of life preserved.

## Summary

CheckMate 9ER, trial NCT03141177 sponsored by Bristol Myers Squibb and Exelixis and reported in 2020, showed that nivolumab with cabozantinib doubled progression-free survival versus sunitinib in untreated advanced clear-cell renal cell carcinoma and lengthened life, with quality of life preserved. It randomised 651 patients, met its primary progression-free survival endpoint, improved overall survival with the effect narrowing at the final four-year analysis, and led to FDA approval in January 2021; cabozantinib's MET and AXL activity is a proposed contributor. OnCo links it to renal cell carcinoma, nivolumab, cabozantinib, sunitinib, Robert J. Motzer, Toni K. Choueiri and James Larkin. Choosing between the IO-TKI doublets without head-to-head data is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03141177
- Phase: 3
- Setting: Untreated advanced clear-cell RCC: nivolumab + cabozantinib vs sunitinib
- Sponsor: BMS / Exelixis
- Enrolled: 701
- Result: PFS HR 0.51; OS HR 0.77 at ~4 years (46.5 vs 36.0 months).
- Outcomes: Progression-free survival: Nivolumab + cabozantinib 16.6 months vs Sunitinib 8.3 months, HR 0.51; Overall survival (final): Nivolumab + cabozantinib 46.5 months vs Sunitinib 36 months, HR 0.77
- Replication: Consistent with other IO-TKI doublets; COSMIC-313 (adding cabozantinib to nivolumab-ipilimumab) improved PFS but not OS.

## Sources

- ClinicalTrials.gov NCT03141177: https://clinicaltrials.gov/study/NCT03141177

## Connected records

- cancers: [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Cabozantinib](https://onco.cc/drugs/cabozantinib/), [Nivolumab](https://onco.cc/drugs/nivolumab/), [Sunitinib](https://onco.cc/drugs/sunitinib/)
- companies: [Exelixis](https://onco.cc/companies/exelixis/)
- people: [James Larkin](https://onco.cc/people/james-larkin/), [Robert J. Motzer](https://onco.cc/people/robert-motzer/), [Toni K. Choueiri](https://onco.cc/people/toni-choueiri/)
- terms: [Progression-free survival (PFS)](https://onco.cc/terms/pfs/), [Quality of life and patient-reported outcomes (QoL, PRO)](https://onco.cc/terms/qol-pro/), [Quality-adjusted survival (QALYs and Q-TWiST)](https://onco.cc/terms/quality-adjusted-survival/)

---
JSON: https://onco.cc/api/v1/entities/checkmate-9er.json