Phase 3
Completed N=706
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Source: ClinicalTrials.gov NCT02752074 ↗Enrolled (actual)
706
Serious AEs
28.2%
Results posted
May 2019
Primary outcomePrimary: Progression-free Survival — 4.7; 4.9 months — p=0.51711
◆ Published Evidence
Highly cited
941citations · ~134 / year
Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study.
Summary
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
Linked Publications
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Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
4.7; 4.9 | 0.51711 |
| PRIMARY Overall Survival (OS) Rate at 6 Months |
84.1; 87.2 | 0.80666 |
| SECONDARY Objective Response Rate (ORR) |
121; 111 | — |
| SECONDARY Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events |
346; 345; 99; 100 | — |
| SECONDARY Duration of Response (DOR) |
NA; NA | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Epacadostat |
59.8 | — |
| SECONDARY Apparent Volume of Distribution (Vd/F) of Epacadostat |
139 | — |
| SECONDARY Clearance (CL) of Pembrolizumab |
— | — |
| SECONDARY Volume of Distribution (V) of Pembrolizumab |
— | — |
| SECONDARY Formation of Anti-pembrolizumab Antibodies |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02752074) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.