At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed RCC with clear cell component, with or without sarcomatoid features
- ✓Intermediate-high risk (pT2 Grade 4 or sarcomatoid, or pT3 any grade), high risk (pT4 any grade or any pT with N+), or M1 NED with completely resected soft tissue metastases
- ✓No prior systemic therapy for advanced RCC
- ✓Complete partial or radical nephrectomy with negative margins; ≥28 days and ≤12 weeks prior to randomization
- ✕Major surgery other than nephrectomy/metastasectomy within 12 weeks prior to randomization
- ✕Prior radiotherapy for RCC
- ✕Pre-existing brain or bone metastatic lesions
- ✕Residual thrombus in renal/caval vessels post-nephrectomy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab and Placebo for Renal Cell Carcinoma. Completed, enrolled 994 participants across 251 sites in 21 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.
Study Details
Timeline
Interventions
IV infusion
IV infusion