Keynote 564
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.
The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.
CLINICALTRIALS.GOV IDENTIFIER:
NCT03142334
When speaking to your doctor, please have the trial identifier number available.
Patients who enroll 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 randomization) to one of the above study groups.
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
Renal Cell Carcinoma
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:
NCT03142334
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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