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.
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
None
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo CT and PET/CT
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Patient Observation
Other interventionUndergo active surveillance
Pembrolizumab
Biological/VaccineGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Disease-free survival (DFS)
A superiority test of DFS for pembrolizumab arm versus (vs.) active surveillance arm will be performed at one-sided 0.025 significance level, using a stratified log-rank test assuming exponential failure.
Overall survival (OS)
OS will be assessed among all randomized patients. Kaplan-Meier estimate will characterize OS and OS comparison will be made for pembrolizumab vs. active surveillance arm using stratified log-rank test and assuming exponential failure.
Incidence of adverse events
Adverse events will be described separately for patients treated on each arm to evaluate safety and tolerability. Toxicity will be defined using the Common Terminology Criteria for Adverse Events. All patients who receive treatment, regardless of eligibility, will be evaluated for toxicity. The 90% confidence interval for the true probability of observing a toxicity of Grade 4 or higher on a given arm will be no wider than 12.1% for each arm. The probability of observing one or more toxicities on a given arm with a true rate of 1% is 86.6% for each arm.
DFS among those that are circulating tumor deoxyribonucleic acid (ctDNA) positive
The first ctDNA analysis objective is to compare DFS between patients randomized to pembrolizumab arm vs. active surveillance arm among patients that are ctDNA positive at baseline. Among patients that are ctDNA positive at baseline, DFS will be compared between patients randomized to pembrolizumab arm vs. surveillance arm using a stratified log-rank test at 0.05 two-sided alpha level assuming exponential failure. Hazard ratios (HRs) for recurrence or death will be reported using a univariable cox proportional hazards model.
OS among those that are ctDNA positive
The second ctDNA analysis objective is to compare OS between patients randomized to pembrolizumab arm vs. active surveillance arm among patients that are ctDNA positive at baseline. Among 72 patients that are predicted to be ctDNA positive at baseline, OS will be compared between patients randomized to Pembrolizumab arm vs. surveillance arm using a stratified log-rank test at 0.05 two-sided alpha level assuming exponential failure. HRs for recurrence or death will be reported using a univariable cox proportional hazards model.
DFS by sex
Estimates of the primary outcome treatment effect and the corresponding 95% confidence interval will be provided by sex.
DFS by race
Estimates of the primary outcome treatment effect and the corresponding 95% confidence interval will be provided by race.
DFS by ethnicity
Estimates of the primary outcome treatment effect and the corresponding 95% confidence interval will be provided by ethnicity.
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