Keynote Trials for Head & Neck Cancer

As the sponsor of the Keynote Oncology Clinical Trials, Merck is passionate about improving health. We are committed to accelerating every step in the journey in our quest to bring treatment options to people with cancer.

Below are trials currently being conducted in head & neck cancer, evaluating the investigational study drug, pembrolizumab (MK-3475).

Active Clinical Trials

The cancer types listed below currently have active trial listings on clinicaltrials.gov. Click on a study name to be directed to that trial's information, or call 1-888-577-8839 to find a study site near you for the trial you are interested in.

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Study of Pembrolizumab or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).

more about the study
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Pembrolizumab Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer

This is a study of pembrolizumab versus standard treatment (methotrexate, docetaxel, or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival and overall survival when compared to standard treatment.

more about the study
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A Study of Pembrolizumab for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that pembrolizumab prolongs progression free survival compared to standard treatment.

more about the study
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Study of MK-3475 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy

This is a study of single-agent pembrolizumab in participants with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful objective response rate (ORR).

more about the study

Nasopharyngeal

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Study of Pembrolizumab in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer

This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival (PFS) and overall survival (OS) when compared to SOC treatment.

more about the study

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.