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Completed

NCT Number: NCT02752074

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

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pembrolizumab + epacadostat

Drug
  • 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)

pembrolizumab + placebo

Drug
  • 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)

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 26, 2016
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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