Eligibility
18+
All Sexes
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Study Summary
This trial looks at whether adding epacadostat to pembrolizumab improves outcomes for patients with previously untreated metastatic renal cell carcinoma.
Eligible Conditions
- Renal Cell Carcinoma
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
Month 15
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Month 6
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
SoC (Sunitinib or Pazopanib)
1 of 2
Pembrolizumab + Epacadostat
1 of 2
Active Control
Experimental Treatment
129 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3
Pembrolizumab + EpacadostatExperimental Group · 2 Interventions: Pembrolizumab, Epacadostat · Intervention Types: Drug, Drug
SoC (Sunitinib or Pazopanib)ActiveComparator Group · 2 Interventions: Sunitinib, Pazopanib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Epacadostat
Not yet FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: data reported from start of study to data cutoff 28-feb-2019, up to 15 months.
Who is running the clinical trial?
Incyte CorporationLead Sponsor
309 Previous Clinical Trials
46,183 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,653 Previous Clinical Trials
4,953,478 Total Patients Enrolled
Mark Jones, MDStudy DirectorIncyte Corporation
8 Previous Clinical Trials
1,866 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Cancer Related
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