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.

Must not have

Known additional malignancy that has progressed or has required active treatment in the last 3 years.

History of (noninfectious) pneumonitis that required steroids or current pneumonitis.

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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My kidney cancer is advanced or has spread, and tests show it's mostly clear-cell type.

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I have not had any treatment for my kidney cancer that has spread.

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I am mostly able to care for myself and carry out daily activities.

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I can provide a sample of my tumor, either from previous tests or a new biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancer progress or need treatment in the last 3 years.

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I have had pneumonitis treated with steroids or have it now.

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I have not had a major heart problem in the last year.

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I have cancer that has spread to my brain or surrounding membranes.

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I have been treated for an autoimmune disease in the last 2 years.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and data reported from start of study to data cutoff 28-feb-2019, up to 15 months. for reporting.