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

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

pembrolizumab + epacadostat

pembrolizumab + placebo

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab + Epacadostat

Pembrolizumab + Placebo

Arm Description

Pembrolizumab + Epacadostat

Pembrolizumab + Placebo

Outcomes

Primary Outcome Measures

Progression-free Survival

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.

Overall Survival (OS) Rate at 6 Months

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 Outcome Measures

Objective Response Rate (ORR)

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.

Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events

Safety and tolerability, as assessed by percentage of participants with adverse events and changes in laboratory parameters.

Duration of Response (DOR)

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.

Apparent Oral Clearance (CL/F) of Epacadostat

Defined as oral dose clearance.

Apparent Volume of Distribution (Vd/F) of Epacadostat

Apparent volume of distribution after administration.

Clearance (CL) of Pembrolizumab

Volume of Distribution (V) of Pembrolizumab

Formation of Anti-pembrolizumab Antibodies

Evaluate the measurement of anti-drug antibodies (ADA).

Full Information

NCT ID

NCT02752074

First Posted

April 22, 2016

Last Updated

August 14, 2020

Sponsor

Incyte Corporation

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02752074

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 21, 2016 (Actual)

Primary Completion Date

January 8, 2018 (Actual)

Study Completion Date

August 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Incyte Corporation

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Melanoma, Metastatic Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

706 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab + Epacadostat

Arm Type

Experimental

Arm Description

Pembrolizumab + Epacadostat

Arm Title

Pembrolizumab + Placebo

Arm Type

Active Comparator

Arm Description

Pembrolizumab + Placebo

Intervention Type

Drug

Intervention Name(s)

pembrolizumab + epacadostat

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

pembrolizumab + placebo

Intervention Description

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 Measure Information:

Title

Progression-free Survival

Description

Time Frame

Assessed every 9 weeks for duration of study participation which is estimated to be 24 months

Title

Overall Survival (OS) Rate at 6 Months

Description

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.

Time Frame

Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

Assessed every 9 weeks for duration of study participation which is estimated to be 24 months

Title

Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events

Description

Safety and tolerability, as assessed by percentage of participants with adverse events and changes in laboratory parameters.

Time Frame

Through up to 90 days after end of treatment, up to 27 months

Title

Duration of Response (DOR)

Description

Time Frame

Assessed every 9 weeks for duration of study participation which is estimated to be 24 months

Title

Apparent Oral Clearance (CL/F) of Epacadostat

Description

Defined as oral dose clearance.

Time Frame