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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 : Recruiting
First Posted : August 24, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 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
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Experimental: Group 1
Pembrolizumab + epacadostat
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475
Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Name: INCB024360
Active Comparator: Group 2
Sunitinib or pazopanib
Drug: Sunitinib
Sunitinib administered orally once daily.
Other Names:
  • Sutent
  • SU11248
Drug: Pazopanib
Pazopanib administered orally once daily.
Other Name: Votrient



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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])

  6. 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

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

  Show 124 Study Locations
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
Study Director: Mark Jones, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03260894     History of Changes
Other Study ID Numbers: 679-00/ECHO-302
2017-002259-26 ( EudraCT Number )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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-deoxygenase 1 (IDO1) inhibitor

Additional relevant MeSH terms:
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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors