# Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study

Source: https://onco.cc/key-papers/paper-pembrolizumab-head-and-neck-j-clin-oncol-2017/  
OnCo record `paper-pembrolizumab-head-and-neck-j-clin-oncol-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Phase 2 or 3 results paper on Pembrolizumab in Head and neck squamous cell carcinoma, in Journal of Clinical Oncology (2017), one of the most cited Europe PMC records with Pembrolizumab in its title.

## Summary

Purpose There are no approved treatments for recurrent/metastatic head and neck squamous cell carcinoma refractory to platinum and cetuximab. In the single-arm, phase II KEYNOTE-055 study, we evaluated pembrolizumab, an anti-programmed death 1 receptor antibody, in this platinum- and cetuximab-pretreated population with poor prognosis. Methods Eligibility stipulated disease progression within 6 months of platinum and cetuximab treatment. Patients received pembrolizumab 200 mg every 3 weeks. Imaging was performed every 6 to 9 weeks. Primary end points: overall response rate (Response Evaluation Criteria in Solid Tumors v1.1, central review) and safety. Efficacy was assessed in all dosed patients and in subgroups on the basis of programmed death ligand 1 (PD-L1) expression and human papillomavirus (HPV) status. Results Among 171 patients treated, 75% received two or more prior lines of therapy for metastatic disease, 82% were PD-L1 positive, and 22% were HPV positive. At the time of analysis, 109 patients (64%) experienced a treatment-related adverse event; 26 patients (15%) experienced a grade ≥ 3 event. Seven patients (4%) discontinued treatment, and one died of treatment-related adverse events. Overall response rate was 16% (95% CI, 11% to 23%), with a median duration of response of 8 months (range, 2+ to 12+ months); 75% of responses were ongoing at the time of analysis. Response rates were similar in all HPV and PD-L1 subgroups. Median progression-free survival was 2.1 months, and median overall survival was 8 months. Conclusion Pembrolizumab exhibited clinically meaningful antitumor activity and an acceptable safety profile in recurrent/metastatic head and neck squamous cell carcinoma previously treated with platinum and cetuximab.

Indexed on Europe PMC as PubMed record 28328302 (DOI 10.1200/jco.2016.70.1524). Its title names Pembrolizumab and its text names Head and neck squamous cell carcinoma; PubMed types it as a clinical trial report (Clinical Trial, Phase II, research-article, Multicenter Study). It was matched automatically to the idea "Test one-tenth-dose immunotherapy where the full dose is unaffordable" and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Journal of Clinical Oncology
- Year: 2017
- DOI: 10.1200/jco.2016.70.1524
- Authors: Bauml J, Seiwert TY, Pfister DG, et al.
- What it means: One of the most cited trial reports Europe PMC returns for Pembrolizumab in Head and neck squamous cell carcinoma, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched by Pembrolizumab in the title and Head and neck squamous cell carcinoma in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a phase 2 or 3 report by the record's publication type or its own wording, not by reading the paper.

## Sources

- J Clin Oncol 2017: https://doi.org/10.1200/jco.2016.70.1524
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28328302/
- Europe PMC: https://europepmc.org/article/MED/28328302

## Connected records

- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)
- ideas: [Photoimmunotherapy as an in situ vaccine with PD-1 blockade](https://onco.cc/ideas/idea-photoimmunotherapy-plus-pd1/), [Test one-tenth-dose immunotherapy where the full dose is unaffordable](https://onco.cc/ideas/idea-cost-low-dose-immunotherapy-trials/)

---
JSON: https://onco.cc/api/v1/entities/paper-pembrolizumab-head-and-neck-j-clin-oncol-2017.json