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History of Changes for Study: NCT02752074
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
Latest version (submitted August 14, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 22, 2016 None (earliest Version on record)
2 April 27, 2016 Outcome Measures and Study Status
3 June 13, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 July 25, 2016 Contacts/Locations and Study Status
5 September 1, 2016 Study Status and Contacts/Locations
6 October 3, 2016 Study Status and Contacts/Locations
7 November 11, 2016 Contacts/Locations, Study Status and Study Identification
8 January 17, 2017 Study Status and Contacts/Locations
9 April 14, 2017 Study Status and Contacts/Locations
10 September 5, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
11 May 2, 2018 Contacts/Locations, Study Status and Outcome Measures
Show
Results Submission Events
12 May 13, 2019 Study Status, Outcome Measures, Document Section, Results, IPDSharing, Contacts/Locations and Study Description
13 August 22, 2019 Recruitment Status and Study Status
14 August 14, 2020 Adverse Events, Outcome Measures, Participant Flow, Study Status, More Information, Baseline Characteristics
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Study NCT02752074
Submitted Date:  April 22, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: INCB 24360-301
Brief Title: A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Not yet recruiting
Study Start: May 2016
Primary Completion: May 2018 [Anticipated]
Study Completion: April 2019 [Anticipated]
First Submitted: April 22, 2016
First Submitted that
Met QC Criteria:
April 22, 2016
First Posted: April 26, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 22, 2016
Last Update Posted: April 26, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Incyte Corporation
Responsible Party: Sponsor
Collaborators: Merck Sharp & Dohme LLC
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in subjects with unresectable or metastatic melanoma
Detailed Description:
Open or close this module Conditions
Conditions: Melanoma
Keywords: Melanoma
Metastatic Melanoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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)
Open or close this module Outcome Measures
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 ]

Defined as time from date of randomization until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first.
2. Overall survival
[ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]

Defined as time from date of randomization to date of death due to any cause.
Secondary Outcome Measures:
1. Objective response rate
[ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]

Defined as the proportion of subjects who have best response as complete response or partial response based on RECIST 1.1.
2. Safety and tolerability, as assessed by adverse events and changes in safety assessments including laboratory parameters
[ Time Frame: Through up to 90 days after end of treatment, up to 27 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Merck Sharp & Dohme Corp
Telephone: 1-888-577-8839
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations: United States, Arizona
Scottsdale, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Los Angeles, California, United States
San Francisco, California, United States
Santa Monica, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Maryland
Lutherville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Rochester, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
United States, Washington
Spokane, Washington, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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