Trial intelligence / Profile preview

Pembrolizumab with chemoradiation in locally advanced head and neck cancer

NCT03040999Phase 3

Key facts

Status: Completed
Start: Apr 2017
Primary completion: May 2022
Countries: 21
Sponsor: Merck & Co.
Modality: Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes

Drugs: pembrolizumab
Conditions: head and neck squamous cell carcinoma (HNSCC)

Overview

Phase 3, randomised, double-blind trial in head and neck squamous cell carcinoma (HNSCC) comparing Pembrolizumab + Cisplatin + CRT with Placebo + Cisplatin + CRT (2 arms). Primary endpoint: Event-Free Survival at 62 months. Started Apr 2017; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Pembrolizumab + Cisplatin + CRT
Pembrolizumab with chemoradiation followed by maintenance pembrolizumab
Placebo + Cisplatin + CRT
Placebo with chemoradiation followed by maintenance placebo

Who it enrols

Patients with newly diagnosed locally advanced head and neck squamous cell carcinoma (oropharyngeal, larynx, hypopharynx, or oral cavity) eligible for definitive chemoradiation, with ECOG 0-1, no prior treatment for head and neck cancer, no prior immunotherapy, and no active autoimmune disease or immunosuppression

Endpoints

Primary

Event-Free Survival62 months

Secondary

Overall Survival62 months
Adverse Events88 months
Discontinuation Due to Adverse Event15 months
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Global Health Status45 weeks
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Questionnaire Swallowing45 weeks
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Questionnaire Speech45 weeks
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Questionnaire Pain Symptom45 weeks
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Physical Functioning45 weeks

Results

Not all primary endpoints met

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