ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02752074
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

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

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

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)
Study Start Date : June 2016
Actual Primary Completion Date : February 28, 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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)




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 percentage of subjects with adverse events [ Time Frame: Through up to 90 days after end of treatment, up to 27 months ]
  3. 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 ]
  4. Duration of response [ 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.

  5. Apparent oral clearance (CL/F) of epacadostat [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Evaluate the pharmacokinetics (PK) parameters of epacadostat and evaluating the effect of extrinsic and intrinsic factors to support proposed dosing regimen. PK/Response correlations will be evaluated if feasible.

  6. Apparent volume of distribution (Vd/F) of epacadostat [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Evaluate the pharmacokinetics (PK) parameters of epacadostat and evaluating the effect of extrinsic and intrinsic factors to support proposed dosing regimen. PK/Response correlations will be evaluated if feasible.

  7. Clearance (CL) of pembrolizumab [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Evaluate the pharmacokinetics (PK) parameters of pembrolizumab and evaluating the effect of extrinsic and intrinsic factors to support proposed dosing regimen. PK/Response correlations will be evaluated if possible.

  8. Volume of distribution (V) of pembrolizumab [ Time Frame: Through up to 30 days after the end of treatment, up to 25 months ]
    Evaluate the pharmacokinetics (PK) parameters of pembrolizumab and evaluating the effect of extrinsic and intrinsic factors to support proposed dosing regimen. PK/Response correlations will be evaluated if feasible.

  9. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


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

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02752074     History of Changes
Other Study ID Numbers: INCB 24360-301 (ECHO-301)
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

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