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CompletedLast updated: 30 January 2024

KEYNOTE-679 / ECHO-302: This Phase III trial is evaluating an intravenous immunotherapy drug (Pembrolizumab) and three oral drugs (Epacadostat, Sunitinib and Pazopanib) for the treatment of locally advanced or metastatic renal cell carcinomaA 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)

Clinical summary

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. Group 1 will receive Pembrolizumab intravenously every 3 weeks and Epacadostat orally twice a day. Group 2 will receive Sunitinib orally once a day and Pazopanib orally once a day.

Conditions

This trial is treating patients with renal cell carcinoma.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

KEYNOTE-679 / ECHO-302

More information

Trial Identifiers

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Trial sponsor

Incyte Corporation

Scientific 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)

Eligibility

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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