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

Phase 3

Active, not recruiting

Interventions: Drug: Sunitinib
Drug: Pembrolizumab
Drug: Epacadostat
Drug: Pazopanib

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.

Recruitment & Eligibility

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 v1.1.
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.

Arm && Interventions

Group	Intervention	Description
Pembrolizumab + Epacadostat	Epacadostat	-
SoC (Sunitinib or Pazopanib)	Sunitinib	Standard of care (SoC) (sunitinib or pazopanib monotherapy).
SoC (Sunitinib or Pazopanib)	Pazopanib	Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Pembrolizumab + Epacadostat	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)	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 Outcome Measures

Name	Time	Method
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.	AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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.	AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Locations (140): Pinnacle Oncology Hematology
🇺🇸
Scottsdale, Arizona, United States
Scottsdale Healthcare
🇺🇸
Scottsdale, Arizona, United States
Arizona Oncology Associates PC- HOPE
🇺🇸
Tucson, Arizona, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
UC Davis Comprehensive Cancer Center
🇺🇸
Sacramento, California, United States
Woodlands Medical Specialists, PA
🇺🇸
Pensacola, Florida, United States
Northside Hospital
🇺🇸
Atlanta, Georgia, United States
Atlanta Cancer Care - Conyers
🇺🇸
Conyers, Georgia, United States
Northwest Georgia Oncology Centers Pc
🇺🇸
Marietta, Georgia, United States
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Pinnacle Oncology Hematology
🇺🇸Scottsdale, Arizona, United States