NCT03260894CompletedPhase 3
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 Corporation279 sites in 6 countries129 target enrollmentStarted: December 7, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Incyte Corporation
- Enrollment
- 129
- Locations
- 279
- Primary Endpoint
- Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: Pembrolizumab (Drug)
SoC (Sunitinib or Pazopanib)
Active Comparator
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Intervention: Sunitinib (Drug)
Pembrolizumab + Epacadostat
Experimental
Intervention: Epacadostat (Drug)
SoC (Sunitinib or Pazopanib)
Active Comparator
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Intervention: Pazopanib (Drug)
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.)
Investigators
Study Sites (279)
Loading locations...
Similar Trials
Completed
Phase 3
Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)Head and Neck CancerNCT03358472Incyte Corporation89
Completed
Phase 3
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial CarcinomaUC (Urothelial Cancer)NCT03374488Incyte Corporation84
Completed
Phase 3
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)UC (Urothelial Cancer)NCT03361865Incyte Corporation93
Active, not recruiting
Phase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)Carcinoma, Renal CellNCT04736706Merck Sharp & Dohme LLC1,854
Completed
Phase 2
A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)Lung CancerNCT03322566Incyte Corporation233