Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

The purpose of this study is 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 clear cell component who have not received prior systemic therapy for their mRCC.

Official Title

A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)

Keywords

Renal Cell Carcinoma (RCC)Renal cell carcinomaprogrammed cell death 1 (PD-1) inhibitorindoleamine 23-dioxygenase 1 (IDO1) inhibitorCarcinomaCarcinoma, Renal CellPembrolizumabSunitinibEpacadostatPazopanib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.
  • Measurable disease based on RECIST v1.1.
  • Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
  • Karnofsky performance status ≥ 70%.
  • Adequate organ function per protocol-defined criteria.

You CAN'T join if...

  • Use of protocol-defined prior/concomitant therapy.
  • 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.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Known additional malignancy that has progressed or has required active treatment in the last 3 years.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
  • History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
  • Significant cardiac event within 12 months before Cycle 1 Day 1.

Locations

  • UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
    OrangeCalifornia92868United States
  • Cedars-Sinai Medical Center
    Los AngelesCalifornia90048United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03260894
Phase
Phase 3
Study Type
Interventional
Last Updated