# KEYNOTE-017 (Cancer Immunotherapy Trials Network 09)

Source: https://onco.cc/trials/keynote-017/  
OnCo record `keynote-017` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

KEYNOTE-017 showed that pembrolizumab given as the first treatment shrinks more than half of advanced Merkel cell carcinomas, whether or not the tumour carries the Merkel cell polyomavirus.

## Summary

KEYNOTE-017 was a single-arm phase 2 trial of first-line pembrolizumab in advanced Merkel cell carcinoma run by the Cancer Immunotherapy Trials Network. It tested PD-1 blockade before chemotherapy, on the reasoning that chemotherapy responses in this disease are short and immunosuppressive.

The objective response rate was 56 percent in the first 26 patients (NEJM 2016) and remained 56 percent in the full cohort of 50 (JCO 2019), with responses in both virus-positive and virus-negative tumours and most responses lasting beyond two years. Grade 3 or worse treatment-related events occurred in a minority and were manageable.

Pembrolizumab was approved for Merkel cell carcinoma in December 2018. Together with JAVELIN Merkel 200 it moved immunotherapy to the first line and made chemotherapy a fallback for the minority who do not respond.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT02267603
- Phase: 2
- Setting: Advanced Merkel cell carcinoma, no prior systemic therapy: pembrolizumab
- Sponsor: Cancer Immunotherapy Trials Network / NCI, with Merck
- Enrolled: 50
- Result: Objective response 56%, durable in most responders; similar in virus-positive and virus-negative tumours.
- Outcomes: Objective response rate: Pembrolizumab 56%
- Replication: JAVELIN Merkel 200 part B (first-line avelumab) found a first-line response rate of the same order.

## Sources

- ClinicalTrials.gov NCT02267603: https://clinicaltrials.gov/study/NCT02267603
- NEJM 2016: https://www.nejm.org/doi/full/10.1056/NEJMoa1603702
- JCO 2019: https://ascopubs.org/doi/10.1200/JCO.18.01896

## Connected records

- cancers: [Merkel cell carcinoma](https://onco.cc/cancers/merkel-cell-carcinoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- pathways: [Oncogenic viruses](https://onco.cc/pathways/oncogenic-viruses/)

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