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

Incyte

Status and phase

Completed

Phase 3

Conditions

Melanoma

Treatments

Drug: pembrolizumab + epacadostat

Drug: pembrolizumab + placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02752074

INCB 24360-301 (ECHO-301)

Details and patient eligibility

About

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

Enrollment

706 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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