# CheckMate 025

Source: https://onco.cc/trials/checkmate-025/  
OnCo record `checkmate-025` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CheckMate 025 was the trial that brought immunotherapy to kidney cancer: nivolumab helped people live longer than everolimus after anti-angiogenic drugs had failed, with fewer side effects.

## Summary

CheckMate 025 randomised 821 patients with advanced clear cell renal cell carcinoma who had received one or two prior anti-angiogenic regimens to nivolumab or to everolimus, then the standard second-line drug. The primary endpoint was overall survival.

Nivolumab lengthened overall survival and produced more objective responses than everolimus, regardless of PD-L1 expression, with fewer grade 3 to 4 adverse events and better quality of life. It was approved in the United States in November 2015, the first checkpoint inhibitor in kidney cancer, and the combinations of nivolumab with ipilimumab or cabozantinib that followed (CheckMate 214 and 9ER) moved immunotherapy into first line.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT01668784
- Phase: 3
- Setting: Advanced clear cell renal cell carcinoma after one or two anti-angiogenic therapies: nivolumab against everolimus
- Sponsor: Bristol Myers Squibb
- Enrolled: 821
- Result: Nivolumab improved overall survival and response rate over everolimus in previously treated clear cell renal cell carcinoma; approved in November 2015.

## Sources

- ClinicalTrials.gov NCT01668784: https://clinicaltrials.gov/study/NCT01668784

## Connected records

- cancers: [Clear cell renal cell carcinoma](https://onco.cc/cancers/clear-cell-rcc/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- drugs: [Everolimus](https://onco.cc/drugs/everolimus/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- people: [Robert J. Motzer](https://onco.cc/people/robert-motzer/)

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JSON: https://onco.cc/api/v1/entities/checkmate-025.json