This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Incyte Corporation
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02752074
First received: April 22, 2016
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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

Condition Intervention Phase
Melanoma Drug: pembrolizumab + epacadostat Drug: pembrolizumab + placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • Safety and tolerability, as assessed by percentage of subjects 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 subjects with changes in laboratory parameters [ Time Frame: Through up to 90 days after end of treatment, up to 27 months ]

Estimated Enrollment: 600
Study Start Date: June 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02752074

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

  Show 129 Study Locations
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
Study Director: Mark Jones, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02752074     History of Changes
Other Study ID Numbers: INCB 24360-301 (ECHO-301)
Study First Received: April 22, 2016
Last Updated: April 14, 2017

Keywords provided by Incyte Corporation:
Melanoma
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017