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)

Incyte Corporation140 sites in 6 countries129 target enrollmentDecember 7, 2017

ConditionsRenal Cell Carcinoma (RCC)

InterventionsPembrolizumab Epacadostat Sunitinib Pazopanib

DrugsPembrolizumab Epacadostat Sunitinib Pazopanib

Overview

Phase: Phase 3
Intervention: Pembrolizumab
Conditions: Renal Cell Carcinoma (RCC)
Sponsor: Incyte Corporation
Enrollment: 129
Locations: 140
Primary Endpoint: Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 7, 2017

End Date

June 4, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
•Must not have received any prior systemic therapy for their mRCC.
•Measurable disease based on RECIST v1.
•Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
•Karnofsky performance status ≥ 70%.
•Adequate organ function per protocol-defined criteria.

Exclusion Criteria

•Use of protocol-defined prior/concomitant therapy.
•Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
•History of severe hypersensitivity reaction to study treatments or their excipients.
•Active autoimmune disease that has required systemic treatment in past 2 years.
•Known additional malignancy that has progressed or has required active treatment in the last 3 years.
•Known active central nervous system metastases and/or carcinomatous meningitis.
•History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
•History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
•Significant cardiac event within 12 months before Cycle 1 Day 1.

Arms & Interventions

Pembrolizumab + Epacadostat

Intervention: Pembrolizumab

Pembrolizumab + Epacadostat

Intervention: Epacadostat

SoC (Sunitinib or Pazopanib)

Standard of care (SoC) (sunitinib or pazopanib monotherapy).

Intervention: Sunitinib

SoC (Sunitinib or Pazopanib)

Standard of care (SoC) (sunitinib or pazopanib monotherapy).

Intervention: Pazopanib

Outcomes

Primary Outcomes

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)

Time Frame: Minimum up to 6 months

ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.

Secondary Outcomes

Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)(Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.)
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs(Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.)