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A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

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ClinicalTrials.gov Identifier: NCT02752074
Recruitment Status : Completed
First Posted : April 26, 2016
Results First Posted : May 15, 2019
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief Summary:
The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma

Condition or disease Intervention/treatment Phase
Melanoma Drug: pembrolizumab + epacadostat Drug: pembrolizumab + placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Actual Study Start Date : June 21, 2016
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pembrolizumab + Epacadostat
Pembrolizumab + Epacadostat
 Drug: pembrolizumab + epacadostat
  • Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
  • Epacadostat will be administered orally daily starting at Day 1 (Week 1)
Active Comparator: Pembrolizumab + Placebo
Pembrolizumab + Placebo
 Drug: pembrolizumab + placebo
  • Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
  • Placebo will be administered orally daily starting at Day 1 (Week 1)


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]
    Progression-free survival, defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.

  2. Overall Survival (OS) Rate at 6 Months [ Time Frame: Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated. ]
    Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]
    Objective response rate (ORR) is defined as the percentage of the participants in the analysis population who have a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 by independent central review.

  2. Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events [ Time Frame: Through up to 90 days after end of treatment, up to 27 months ]
    Safety and tolerability, as assessed by percentage of participants with adverse events and changes in laboratory parameters.

  3. Duration of Response (DOR) [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 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. Includes participants with complete response or partial response.

  4. Apparent Oral Clearance (CL/F) of Epacadostat [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Defined as oral dose clearance.

  5. Apparent Volume of Distribution (Vd/F) of Epacadostat [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Apparent volume of distribution after administration.

  6. Clearance (CL) of Pembrolizumab [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
  7. Volume of Distribution (V) of Pembrolizumab [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
  8. Formation of Anti-pembrolizumab Antibodies [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Evaluate the measurement of anti-drug antibodies (ADA).


Eligibility Criteria
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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:

  • Have histologically or cytologically confirmed melanoma
  • Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
  • A minimum of 1 measurable lesion by CT or MRI
  • Provide a baseline tumor biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

  • Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
  • Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
  • Has an active infection requiring systemic therapy
  • Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Has known history of or is positive for Hepatitis B or Hepatitis C
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Contacts and Locations
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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): NCT02752074


Locations
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Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme LLC
Investigators
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Study Director: Mark Jones, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] May 18, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02752074    
Other Study ID Numbers: INCB 24360-301 (ECHO-301)
First Posted: April 26, 2016    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: August 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Incyte Corporation:
Melanoma
Metastatic Melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Skin Neoplasms
Neoplasms by Site
Skin Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action