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A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

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ClinicalTrials.gov Identifier: NCT03322566
Recruitment Status : Completed
First Posted : October 26, 2017
Results First Posted : January 29, 2020
Last Update Posted : January 6, 2021
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
Results First Submitted Date  ICMJE December 10, 2019
Results First Posted Date  ICMJE January 29, 2020
Last Update Posted Date January 6, 2021
Actual Study Start Date  ICMJE January 9, 2018
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo [ Time Frame: Assessed after a minimum of 12 weeks of follow-up ( Data Cut Off of 13-Dec 18). ]
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Overall survival of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy [ Time Frame: Up to 60 months ]
    Defined as the time from randomization to death due to any cause.
  • Progression-free survival of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy [ Time Frame: Approximately 24 months ]
    Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
  • Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo [ Time Frame: Assessed from the start of the study until death or PD, whichever was earlier until the Data Cut Off of 13-Dec 18. ]
    Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
  • Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo [ Time Frame: Assessed from the start of study until the Data Cut Off of 13-Dec 18. ]
    Defined as the time from randomization to death due to any cause.
  • Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo [ Time Frame: Assessed from the fist dose until the Data Cut Off of 13-Dec 18. ]
    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 + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Assessed from the fist dose until the Data Cut Off of 13-Dec 18. ]
    An AE is defined as any untoward medical occurrence in a participant 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 + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Assessed from the fist dose until the Data Cut Off of 13-Dec 18. ]
    An AE is defined as any untoward medical occurrence in a participant 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 epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy. [ Time Frame: Approximately 24 months ]
    Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
  • Duration of response of epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy. [ 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 epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy as measured by the number of participants experiencing adverse events (AEs). [ Time Frame: Up to 37 months ]
    An 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 epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy as measured by the number of participants discontinuing study drug due to AEs. [ Time Frame: Up to 37 months ]
    An 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
Official Title  ICMJE A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer
Brief Summary The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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: Platinum-based chemotherapy
    Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
  • Drug: Placebo
    Matching placebo administered orally twice daily.
Study Arms  ICMJE
  • Experimental: Pembrolizumab + Chemotherapy + Epacadostat
    Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Epacadostat
    • Drug: Platinum-based chemotherapy
  • Experimental: Pembrolizumab + Chemotherapy + Placebo
    Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Platinum-based chemotherapy
    • Drug: Placebo
  • Experimental: Pembrolizumab + Epacadostat
    Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Epacadostat
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
233
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2017)
1062
Actual Study Completion Date  ICMJE October 16, 2020
Actual Primary Completion Date December 13, 2018   (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
  • 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.
  • Provide tumor tissue sample.

Exclusion Criteria:

  • Known untreated central nervous system metastases and/or carcinomatous meningitis
  • History of (non-infectious) 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Mexico,   Russian Federation,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Brazil,   France,   Germany,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT03322566
Other Study ID Numbers  ICMJE KEYNOTE-715-06/ECHO-306-06
2017-001810-27 ( EudraCT Number )
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  ICMJE
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 December 2020

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