Pembrolizumab for Renal Cell Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Renal Cell Carcinoma+2 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

2 of 3
This is further along than 85% of similar trials

Other trials for Renal Cell Carcinoma

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

3 of 3
This is further along than 85% of similar trials

Other trials for Renal Cell Carcinoma

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

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

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.