NCT03260894

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma (RCC)

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg administered intravenously every 3 weeks.
DRUG	Epacadostat	Epacadostat 100 mg administered orally twice daily.
DRUG	Sunitinib	Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
DRUG	Pazopanib	Pazopanib 800 mg administered orally once daily.

Timeline

• Start date: 2017-12-07
• Primary completion: 2018-08-22
• Completion: 2025-06-04
• First posted: 2017-08-24
• Last updated: 2025-07-29
• Results posted: 2019-09-10

Locations

140 sites across 20 countries: United States, Australia, Brazil, Canada, Chile, France, Germany, Hungary, Ireland, Italy, Japan, New Zealand, Norway, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study