Keynote 412
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).
CLINICALTRIALS.GOV IDENTIFIER:
NCT03040999
When speaking to your doctor, please have the trial identifier number available.
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.
Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.
Dates
Conditions
Head and Neck Neoplasms
Age Range
18 - No Age Maximum
Sex
All
If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.
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CLINICALTRIALS.GOV IDENTIFIER:
NCT03040999
When speaking to your doctor, please have the trial identifier number available.
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.
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