# KEYNOTE-006

Source: https://onco.cc/trials/keynote-006/  
OnCo record `keynote-006` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that made PD-1 blockade the first choice over the older CTLA-4 drug, with a third of patients alive at ten years.

## Summary

Pembrolizumab improved PFS and OS versus ipilimumab with fewer high-grade side effects. The 10-year analysis (Annals of Oncology 2024) reported OS 34.0% versus 23.6%; patients who completed two years of pembrolizumab had durable remissions off treatment. Established anti-PD-1 monotherapy as a first-line standard and the two-year treatment duration.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01866319
- Phase: 3
- Setting: Advanced melanoma, ≤1 prior systemic therapy: pembrolizumab (two schedules) vs ipilimumab
- Sponsor: Merck
- Enrolled: 834
- Result: 10-year OS 34.0% vs 23.6%.
- Outcomes: Overall survival at 10 years: Pembrolizumab 34% vs Ipilimumab 23.6%
- Replication: Consistent with CheckMate 066/067 (nivolumab) and long-term KEYNOTE-001 data; PD-1 superiority over ipilimumab is replicated.

## Sources

- ClinicalTrials.gov NCT01866319: https://clinicaltrials.gov/study/NCT01866319
- 10-year follow-up, Annals of Oncology 2024: https://www.annalsofoncology.org/article/S0923-7534(24)03910-3/fulltext

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- people: [Caroline Robert](https://onco.cc/people/caroline-robert/)
- key papers: [KEYNOTE-006 (Robert 2015): pembrolizumab versus ipilimumab in advanced melanoma](https://onco.cc/key-papers/paper-keynote-006-pembrolizumab-ipilimumab-melanoma-nejm-2015/)

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