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KEYNOTE-564 (NCT03142334) Study Design
Key Eligibility Criteria
• Histologically confirmed clear cell renal cell carcinoma N = 496 Pembrolizumab 200 mg
• Intermediate-high risk: pT2, grade 4 or sarcomatoid, Q3W
N0, M0; pT3, any grade, N0, M0 for ~1 year b
• High risk: pT4, any grade, N0, M0; any pT, any R
grade, N+, M0 (1:1)
• M1 no evidence of disease (NED) after surgery a
• Surgery ≤12 weeks prior to randomization Placebo
• No prior systemic therapy N = 498 Q3W
• ECOG PS 0 or 1 for ~1 year b
• Tissue sample for PD-L1 assessment
Stratification Factors
• Metastatic status (M0 vs M1 NED) Primary endpoint: DFS per investigator
• M0 group further stratified: Key secondary endpoint: OS
• ECOG PS 0 vs 1 Other secondary endpoints: Safety
• US vs non-US
• Median (range) time from randomization to cutoff: 30.1 (20.8−47.5) months
Q3W, every 3 weeks.
b
a M1 NED: no evidence of disease after primary tumor + soft tissue metastases completely resected ≤1 year from nephrectomy; ≤17 cycles of treatment were equivalent to ~1 year.
Data cutoff date: June 14, 2021.
