Pembrolizumab + Epacadostat for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+139 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Eligibility Criteria

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

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 treatment for my kidney cancer that has spread.

+3 more

Exclusion Criteria

I am following or have followed the treatment plan as outlined in the study protocol.

Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.

History of severe hypersensitivity reaction to study treatments or their excipients.

+6 more

Participant Groups

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.

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).

Epacadostat is already approved in United States for the following indications:

🇺🇸 Approved in United States as Epacadostat for: