# CheckMate 141

Source: https://onco.cc/trials/checkmate-141/  
OnCo record `checkmate-141` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first immunotherapy to extend survival in head and neck cancer, in patients who had progressed on platinum within six months.

## Summary

CheckMate 141, trial NCT02105636 sponsored by Bristol Myers Squibb and reported in 2016, was the first immunotherapy to extend survival in head and neck cancer, in patients whose disease had progressed on platinum within six months. It randomised 361 patients to nivolumab or investigator's choice of methotrexate, docetaxel or cetuximab, met its primary overall survival endpoint with a durable tail at two years, and preserved quality of life where chemotherapy worsened it, leading to FDA approval in November 2016. OnCo links it to head and neck squamous cell carcinoma, PD-1 as a target and nivolumab, and KEYNOTE-040 with pembrolizumab showed a concordant, borderline survival benefit. Whether the minority with durable benefit can be identified in advance remains the open question for second-line immunotherapy.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02105636
- Phase: 3
- Setting: Platinum-refractory recurrent or metastatic HNSCC: nivolumab vs investigator's choice (methotrexate, docetaxel, or cetuximab)
- Sponsor: BMS
- Enrolled: 361
- Result: OS 7.5 vs 5.1 months; HR 0.70.
- Outcomes: Overall survival: Nivolumab 7.5 months vs Investigator's choice 5.1 months, HR 0.7
- Replication: KEYNOTE-040 (pembrolizumab) showed a concordant, borderline OS benefit.

## Sources

- ClinicalTrials.gov NCT02105636: https://clinicaltrials.gov/study/NCT02105636
- NEJM 2016: https://www.nejm.org/doi/full/10.1056/NEJMoa1602252

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Oral cavity cancer (mouth and tongue)](https://onco.cc/cancers/oral-cavity-cancer/), [Oropharyngeal cancer (tonsil and base of tongue)](https://onco.cc/cancers/oropharyngeal-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/)
- ideas: [Test one-tenth-dose immunotherapy where the full dose is unaffordable](https://onco.cc/ideas/idea-cost-low-dose-immunotherapy-trials/)
- key papers: [CheckMate 141: nivolumab for recurrent head and neck squamous cell carcinoma after platinum](https://onco.cc/key-papers/paper-checkmate-141-ferris-nejm-2016/)

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