To compare disease-free survival (DFS) as assessed by the investigator for patients treated with pembrolizumab versus those receiving placebo
Patients will be randomized to receive placebo or pembrolizumab by intravenous infusion every 3 weeks. Treatment will be up to (approximately) 1 year.
Each patient will participate in the trial from the time the patient signs the informed consent form through the final protocol-specified contact. After a screening phase of up to 42 days, each patient will be assigned to receive trial treatment until disease recurrence, unacceptable adverse events, intercurrent illness that prevents further administration of treatment, oncologist’s decision to withdraw the patient, or until the patient has received 17 cycles of study treatment (approximately 1 year).
After the end of treatment, each patient will be followed for the occurrence of adverse events and spontaneously reported pregnancy
Patients who discontinue for reasons other than disease recurrence will have post-treatment imaging follow-up for disease status until confirmation of disease recurrence, initiating a new anticancer treatment, withdrawing consent, or becoming lost to follow-up.
All patients will be followed by telephone for OS until death, withdrawal of consent, or the end of the study.
- Histologically confirmed diagnosis of Renal Cell Carcinoma (RCC) with clear cell component with or without sarcomatoid features that is considered intermediate-high risk or high risk
- Be 18 years of age or older
- Have no evidence of disease
- Have received no prior systemic therapy for advanced RCC (except nephrectomy or metastasectomy)
- Have undergone a partial nephroprotective or radical complete nephrectomy with negative surgical margins.
Number of Patients: 950
On-Site Study Visits
Patients may be asked to do any or all of the following to measure if the drug is working and/or to monitor their health:
- Dispense study drug and instructions
- Review your medical history
- Perform a physical exam
- Administer study questionnaires
- Perform a computerized tomography (CT) scan, or magnetic resonance imaging (MRI)
- Perform bone scans
- Check your vital signs (including blood pressure, heart rate, temperature, breathing rate) and weight
- Collect blood and urine samples
All patients will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.
Other Procedures During Study Visits
- Give you a patient identification card
- Perform an electrocardiogram (ECG) to measure the activity of your heart