About this trial
This phase III trial compares the effect of pembrolizumab to active surveillance after a surgical procedure to completely or partially remove a kidney (nephrectomy) in improving time without disease in patients with non-clear cell renal cell cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after nephrectomy may be more effective than the usual active surveillance approach for improving time without disease in patients with non-clear cell renal cell cancer.
Eligibility criteria
Qualifiers
Patient must be ≥ 18 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient must have histologically confirmed non-clear cell renal cell carcinoma (nccRCC) with ≥ pT3Nx or pTanyN+ or pTanyNanyM1 with no evidence of disease (NED) per the American Joint Committee on Cancer (AJCC) 8th edition
Patient must not have renal medullary carcinoma
Disqualifiers
None
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Scan
- Computed Tomography
- Echocardiography Test
- Magnetic Resonance Imaging
- Patient Observation
- Pembrolizumab
- Positron Emission Tomography