drugset / Trial / NCT03260894

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

NCT03260894

Phase 3 Completed 129 enrolled Incyte Corporation Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-12-07
Primary completion
2018-08-22
Completion
2025-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Epacadostat Small molecule 100 mg Oral
Comparator Pazopanib Small molecule 800 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Comparator Sunitinib Small molecule 50 mg Oral

Indications