At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Epacadostat, and 2 other interventions for Renal Cell Carcinoma (RCC). Completed, enrolled 129 participants across 140 sites in 20 countries.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.
Study Details
Timeline
Interventions
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Epacadostat 100 mg administered orally twice daily.
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Pazopanib 800 mg administered orally once daily.