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IDO1 Inhibitor
Pembrolizumab + Epacadostat for Kidney Cancer
Phase 3
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data reported from start of study to data cutoff 28-feb-2019, up to 15 months.
Awards & highlights
Study Summary
This trial looks at whether adding epacadostat to pembrolizumab improves outcomes for patients with previously untreated metastatic renal cell carcinoma.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares the effectiveness of combining Pembrolizumab (an immunotherapy drug) with Epacadostat versus standard treatments Sunitinib or Pazopanib in treating mRCC. The goal is to see if this new combination works better for patients who are newly diagnosed with metastatic kidney cancer.See study design
What are the potential side effects?
Pembrolizumab and Epacadostat may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems, fatigue, and flu-like symptoms. Standard treatments also come with risks like high blood pressure, bleeding events, tiredness, and liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is advanced or has spread, and tests show it's mostly clear-cell type.
Select...
I have not had any treatment for my kidney cancer that has spread.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I can provide a sample of my tumor, either from previous tests or a new biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ data reported from start of study to data cutoff 28-feb-2019, up to 15 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data reported from start of study to data cutoff 28-feb-2019, up to 15 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Secondary outcome measures
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)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + EpacadostatExperimental Treatment2 Interventions
Group II: SoC (Sunitinib or Pazopanib)Active Control2 Interventions
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Epacadostat
2018
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,036 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,442 Total Patients Enrolled
Mark Jones, MDStudy DirectorIncyte Corporation
8 Previous Clinical Trials
1,866 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am following or have followed the treatment plan as outlined in the study protocol.You have a disease that can be measured using specific guidelines.My kidney cancer is advanced or has spread, and tests show it's mostly clear-cell type.I have not had any other cancer progress or need treatment in the last 3 years.I have had pneumonitis treated with steroids or have it now.You have a history of a significant abnormal heart test.I have not had a major heart problem in the last year.I have cancer that has spread to my brain or surrounding membranes.I have not had any treatment for my kidney cancer that has spread.I am mostly able to care for myself and carry out daily activities.My organs are working well.I have been treated for an autoimmune disease in the last 2 years.I can provide a sample of my tumor, either from previous tests or a new biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Epacadostat
- Group 2: SoC (Sunitinib or Pazopanib)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please provide a rundown of other Pembrolizumab research that has been conducted?
"Pembrolizumab was first investigated in 2006 by University of Texas MD Anderson Cancer Center. To date, there have been 646 completed trials and 1063 ongoing studies. A large number of these active investigations are based out of Scottsdale, Arizona."
Answered by AI
What medical conditions has Pembrolizumab shown to be effective in treating?
"Pembrolizumab is a medication used to treat solid tumors. It can also be useful for patients with unresectable melanoma, microsatellite instability high, and those at high risk of recurrence."
Answered by AI
Does this research project have a large presence in city?
"There are a total of 31 patients enrolled in this trial, with locations including Pinnacle Oncology Hematology in Scottsdale, Willamette Valley Cancer Institute and Research Center in Eugene, University of Tennessee Erlanger Oncology & Hematology in Chattanooga, and 28 other centres."
Answered by AI
Have there been other similar investigations in the past?
"Since 2006, when the first64-person study was sponsored by Pfizer, there have been 1063 active trials involving pembrolizumab across 63 countries and 3103 cities."
Answered by AI
Is Pembrolizumab being tested for long-term safety in patients?
"Pembrolizumab has received a score of 3 for safety by our team at Power. This is due to the fact that this drug is in Phase 3 clinical trials, meaning there is both some evidence of efficacy and multiple rounds of data supporting its safety."
Answered by AI
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