Keynote 630
This is a randomised, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
CLINICALTRIALS.GOV IDENTIFIER:
NCT03833167
When speaking to your doctor, please have the trial identifier number available.
Patients who enrol in the trial will be assigned to one of the following study groups.
50% will receive pembrolizumab.
50% will receive placebo.
*You will be assigned by chance (a process called randomisation) to receive one of the above treatments. The study doctor will discuss with you what options you have if your cancer comes back while you are in the study.
Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). 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
Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.
Conditions
Carcinoma, Squamous Cell
Age Range
18 - No Age Maximum
Sex
All
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