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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT03260894
Phase
PHASE3
Status
Completed

Conditions

  • Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 7, 2017
Status verified
Apr 2026
Primary completion
Aug 22, 2018
Completion
Jun 4, 2025

Study Design

Enrollment
129 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Epacadostat
  • Active Comparator: SoC (Sunitinib or Pazopanib)
    Standard of care (SoC) (sunitinib or pazopanib monotherapy).

Primary Outcome Measure

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) [ Time Frame: up to approximately 8 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
Pinnacle Oncology HematologyScottsdaleArizona85258-
Scottsdale HealthcareScottsdaleArizona85258-
Arizona Oncology Associates PC- HOPETucsonArizona85711-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Woodlands Medical Specialists, PAPensacolaFlorida32503-
Northside HospitalAtlantaGeorgia30342-
Atlanta Cancer Care - ConyersConyersGeorgia30094-
Northwest Georgia Oncology Centers PcMariettaGeorgia30060-
Rush University Medical CenterChicagoIllinois60612-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Southeast Nebraska Hematology & Oncology Consultants, P.C.LincolnNebraska68510-
New York Oncology Hematology P.CAlbanyNew York12208-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
University of Tennessee Erlanger Oncology & HematologyChattanoogaTennessee37403-
The West Clinic, P.C.GermantownTennessee38138-
US Oncology and ResearchThe WoodlandsTexas77380-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRoanokeVirginia24014-
Shenandoah Oncology, P.C.WinchesterVirginia22601-

Related coverage on Hipa.ai

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By research site
Pinnacle Oncology Hematology· Scottsdale, AZScottsdale Healthcare· Scottsdale, AZArizona Oncology Associates PC- HOPE· Tucson, AZCedars-Sinai Medical Center· Los Angeles, CAUC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center· Orange, CAUC Davis Comprehensive Cancer Center· Sacramento, CA

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