Keynote 412

For patients with locally advanced head and neck squamous cell carcinoma

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).

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational immunotherapy to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 50% will receive pembrolizumab along with cisplatin and radiotherapy
  • 50% will receive placebo along with cisplatin and radiotherapy

You will be assigned by chance (a process called randomization) to receive one of the above treatments.

Trial Purpose
21

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT03040999 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Head and Neck Neoplasms

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

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).

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

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    Location
    Status
  • Springfield, Oregon, United States, 97477
    Recruiting
  • Austin, Texas, United States, 78731
    Recruiting
  • Santa Rosa, California, United States, 95403
    Recruiting
  • Cincinnati, Ohio, United States, 45242
    Recruiting
  • Easton, Pennsylvania, United States, 18045
    Recruiting
  • Longview, Texas, United States, 75601
    Recruiting
  • New Haven, Connecticut, United States, 06510
    Recruiting
  • Indianapolis, Indiana, United States, 46202
    Recruiting
  • Detroit, Michigan, United States, 48201
    Recruiting
  • Charlottesville, Virginia, United States, 22908
    Recruiting
  • Seattle, Washington, United States, 98109
    Recruiting
  • Ann Arbor, Michigan, United States, 48109
    Recruiting
  • Las Vegas, Nevada, United States, 89169
    Recruiting
  • Chicago, Illinois, United States, 60612
    Recruiting
  • Rochester, New York, United States, 14620
    Recruiting
  • Los Angeles, California, United States, 90095
    Recruiting
  • Billings, Montana, United States, 59102
    Recruiting
  • Worcester, Massachusetts, United States, 01655
    Recruiting
  • San Francisco, California, United States, 94115
    Recruiting
  • Spokane, Washington, United States, 99208
    Recruiting
  • Baton Rouge, Louisiana, United States, 70809
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-412

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
keynote 412 trial logo

Call 1-888-577-8839 to contact our trial information center

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.