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Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03260894
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Results First Posted : September 10, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma (RCC) Drug: Pembrolizumab Drug: Epacadostat Drug: Sunitinib Drug: Pazopanib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : August 22, 2018
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Pembrolizumab + Epacadostat Drug: Pembrolizumab
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Epacadostat
Epacadostat 100 mg administered orally twice daily.
Other Name: INCB024360

Active Comparator: SoC (Sunitinib or Pazopanib)
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Drug: Sunitinib
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Other Names:
  • Sutent
  • SU11248

Drug: Pazopanib
Pazopanib 800 mg administered orally once daily.
Other Name: Votrient




Primary Outcome Measures :
  1. Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) [ Time Frame: Minimum up to 6 months ]
    ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.


Secondary Outcome Measures :
  1. Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months. ]
    AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  2. Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months. ]
    AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260894


Locations
Show Show 141 study locations
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Mark Jones, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03260894    
Other Study ID Numbers: KEYNOTE-679/ECHO-302
2017-002259-26 ( EudraCT Number )
First Posted: August 24, 2017    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Renal cell carcinoma
programmed cell death 1 (PD-1) inhibitor
indoleamine 2
3-dioxygenase 1 (IDO1) inhibitor
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Pembrolizumab
Sunitinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action