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Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-04/ECHO-305-04)

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ClinicalTrials.gov Identifier: NCT03322540
Recruitment Status : Active, not recruiting
First Posted : October 26, 2017
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE October 24, 2017
First Posted Date  ICMJE October 26, 2017
Last Update Posted Date February 7, 2019
Actual Study Start Date  ICMJE November 22, 2017
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Objective response rate of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 6 months ]
Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Progression-free survival (PFS) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 24 months ]
    Defined as the time from randomization to the first documented progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
  • Overall survival (OS) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Up to 60 months ]
    Defined as the time from randomization to death due to any cause.
Change History Complete list of historical versions of study NCT03322540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Progression-free survival (PFS) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 36 months ]
    Defined as the time from randomization to the first documented progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
  • Overall survival (OS) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Up to 36 months ]
    Defined as the time from randomization to death due to any cause.
  • Duration of response (DOR) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 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 comes first.
  • Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants experiencing adverse events (AEs) [ Time Frame: Up to 37 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.
  • Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants discontinuing study drug due to AEs [ Time Frame: Up to 37 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Objective response rate of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 24 months ]
    Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) perRECIST v1.1.
  • Duration of response of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 24 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 comes first.
  • Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants experiencing adverse events (AEs) [ Time Frame: Up to 37 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.
  • Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants discontinuing study drug due to AEs [ Time Frame: Up to 37 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.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-04/ECHO-305-04)
Official Title  ICMJE A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1
Brief Summary The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Pembrolizumab
    Pembrolizumab administered intravenously every 3 weeks.
    Other Name: MK-3475
  • Drug: Epacadostat
    Epacadostat administered orally twice daily.
    Other Name: INCB024360
  • Drug: Placebo
    Matching placebo administered orally twice daily.
Study Arms
  • Experimental: Treatment 1
    Pembrolizumab + epacadostat
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Epacadostat
  • Active Comparator: Treatment 2
    Pembrolizumab + matching placebo
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
154
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2017)
588
Estimated Study Completion Date September 2021
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation.
  • Measurable disease based on RECIST 1.1.
  • Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score [TPS] ≥ 50%) as assessed by immunohistochemistry at a central laboratory.
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Known untreated central nervous system metastases and/or carcinomatous meningitis.
  • History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  • Symptomatic ascites or pleural effusion.
  • Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  • Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Estonia,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Brazil,   France,   Germany,   Romania
 
Administrative Information
NCT Number  ICMJE NCT03322540
Other Study ID Numbers  ICMJE KEYNOTE-654-04/ECHO-305-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: Lance Leopold, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date February 2019

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