Pembrolizumab + Epacadostat for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you must not have received any prior systemic therapy for your kidney cancer. It's best to discuss your current medications with the trial team.
Is the combination of Pembrolizumab and Epacadostat safe for humans?
Pembrolizumab has been studied in various cancers and is generally considered safe, but it can cause side effects like fatigue, nausea, and immune-related issues such as inflammation of the lungs, liver, or thyroid. Rarely, it can lead to type 1 diabetes. There is no specific safety data available for the combination with Epacadostat in kidney cancer.12345
What makes the drug combination of Pembrolizumab and Epacadostat unique for kidney cancer?
What data supports the effectiveness of the drug combination of Pembrolizumab and Epacadostat for kidney cancer?
Who Is on the Research Team?
Mark Jones, MD
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for adults with advanced kidney cancer (mRCC) who haven't had any previous systemic treatments. Participants should be relatively healthy, able to perform daily activities (70% on the Karnofsky scale), and have a tumor that can be measured. They must provide a tissue sample of their tumor and not have other active cancers or severe health issues like heart problems or autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab plus epacadostat or standard of care (sunitinib or pazopanib) for locally advanced/metastatic renal cell carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Epacadostat
- Pembrolizumab
Epacadostat is already approved in United States for the following indications:
- None approved; Orphan designation for stage IIB-IV melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University