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Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC

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ClinicalTrials.gov Identifier: NCT03260894
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

August 22, 2017
August 24, 2017
May 9, 2018
December 7, 2017
May 2023   (Final data collection date for primary outcome measure)
  • Progression-free survival of pembrolizumab + epacadostat versus standard of care (SOC) [ Time Frame: Up to 30 months ]
    Defined as time of randomization until the first documented disease progression assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
  • Overall survival of pembrolizumab + epacadostat versus SOC [ Time Frame: Up to 60 months ]
    Defined as the time from randomization to death due to any cause.
Same as current
Complete list of historical versions of study NCT03260894 on ClinicalTrials.gov Archive Site
  • Objective response rate of pembrolizumab + epacadostat versus SOC [ Time Frame: Up to 36 months ]
    Defined as proportion of participants who have a best response of complete response (CR) or partial response (PR) as measured per RECIST v1.1.
  • Duration of response of pembrolizumab + epacadostat versus SOC [ Time Frame: Up to 36 months ]
    Defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
  • Safety and tolerability of pembrolizumab + epacadostat versus SOC as measured by number of participants experiencing adverse events (AEs) [ Time Frame: Up to 39 months ]
    AEs 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.
  • Safety and tolerability of pembrolizumab + epacadostat versus SOC as measured by number of participants discontinuing study drug due to AEs [ Time Frame: Up to 39 months ]
    AEs 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
  • Health-related quality of life (HRQoL) of pembrolizumab + epacadostat versus SOC as measured by time to deterioration (TTD) [ Time Frame: Up to 36 months ]
    TTD based on the Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) and its subset of items designated in disease-related symptoms (Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms [FKSI DRS])
  • HRQoL of pembrolizumab + epacadostat versus SOC as measured by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life scale [ Time Frame: Up to 42 weeks ]
    The EORTC QLQ C30 is a psychometrically and clinically validated instrument appropriate for assessing HRQoL in oncology studies
  • HRQoL of pembrolizumab + epacadostat versus SOC as measured by European Quality of Life (EuroQol) EQ-5D™ 3 level version (EQ 5D-3L) assessment [ Time Frame: Up to 36 months ]
    The EuroQoL EQ-5D is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses.
Same as current
Not Provided
Not Provided
 
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma (RCC)
  • Drug: Pembrolizumab
    Pembrolizumab administered intravenously every 3 weeks.
    Other Name: MK-3475
  • Drug: Epacadostat
    Epacadostat administered orally twice daily.
    Other Name: INCB024360
  • Drug: Sunitinib
    Sunitinib administered orally once daily.
    Other Names:
    • Sutent
    • SU11248
  • Drug: Pazopanib
    Pazopanib administered orally once daily.
    Other Name: Votrient
  • Experimental: Group 1
    Pembrolizumab + epacadostat
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Epacadostat
  • Active Comparator: Group 2
    Sunitinib or pazopanib
    Interventions:
    • Drug: Sunitinib
    • Drug: Pazopanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
630
Same as current
June 2023
May 2023   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   Chile,   France,   Germany,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Norway,   Russian Federation,   Spain,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
 
 
NCT03260894
679-00/ECHO-302
2017-002259-26 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Incyte Corporation
Incyte Corporation
Merck Sharp & Dohme Corp.
Study Director: Mark Jones, MD Incyte Corporation
Incyte Corporation
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP