Study on the Safety and Effectiveness of Pembrolizumab for Kidney Cancer After Surgery

Inclusion Criteria

• Diagnosed with renal cell carcinoma (RCC) with a clear cell component, with or without certain features.
• Women who can have children must agree to use birth control during the study and for 120 days after the last dose.
• Men who can father children must agree to use birth control during the study and for 120 days after the last dose.
• Have intermediate-high risk, high risk, or M1 NED RCC, defined by specific medical criteria.
• Have not received any prior systemic therapy for advanced RCC.
• Have had a kidney surgery (nephrectomy) and, if applicable, removal of any isolated metastases, with no cancer left behind.
• Surgery must have been done at least 28 days before joining the study and no more than 12 weeks before starting treatment.
• Must be cancer-free as confirmed by scans of the brain, chest, abdomen, pelvis, and bones within 28 days of starting the study.
• Must provide tissue samples from surgery for study purposes.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function as determined by medical tests.

Exclusion Criteria

• Have had major surgery, other than kidney surgery or removal of metastases, within 12 weeks before starting the study.
• Have received prior radiation therapy for RCC.
• Have existing brain or bone metastases.
• Have a blood clot remaining after kidney surgery.
• Have an immune deficiency or are on high-dose steroids or other immune-suppressing medications.
• Have an active autoimmune disease needing treatment in the past 2 years.
• Have another progressing cancer or one that needed treatment in the past 3 years, with some exceptions.
• Have a history of lung inflammation needing steroids or current lung inflammation.
• Have an active infection needing treatment.
• Have a history of or are currently on dialysis.
• Have a known history of HIV, active hepatitis B or C, or tuberculosis.
• Have had a prior organ transplant.
• Have a severe allergy to pembrolizumab or its ingredients.
• Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after.
• Have received prior treatment with certain immune therapies or participated in a pembrolizumab trial.
• Have received recent anticancer therapy or investigational treatments.
• Have received a live vaccine within 30 days before starting the study.
• Are currently in another clinical trial or have been in one recently.