Trials Sponsors Conditions Drugs Pricing

Conditions

Melanoma

Keywords

MelanomaMetastatic Melanoma

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (8)

Objective Response Rate (ORR)
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events
Through up to 90 days after end of treatment, up to 27 months
Duration of Response (DOR)
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Apparent Oral Clearance (CL/F) of Epacadostat
Through up to 30 days after the end of treatment, up to 25 months
Apparent Volume of Distribution (Vd/F) of Epacadostat
Through up to 30 days after the end of treatment, up to 25 months
+3 more secondary outcomes

Study Arms (2)

Pembrolizumab + Epacadostat

EXPERIMENTAL

Pembrolizumab + Epacadostat

Drug: pembrolizumab + epacadostat

Pembrolizumab + Placebo

ACTIVE COMPARATOR

Pembrolizumab + Placebo

Drug: pembrolizumab + placebo

Interventions

pembrolizumab + epacadostatDrug

* 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 + Epacadostat

pembrolizumab + placeboDrug

* 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)

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
pembrolizumab + epacadostat
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have histologically or cytologically confirmed melanoma
Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy

Sponsors & Collaborators

Incyte Corporation
Industrylead
Merck Sharp & Dohme LLC
Industrycollaborator

Study Sites (129)

Birmingham, Alabama, United States

Scottsdale, Arizona, United States

Little Rock, Arkansas, United States

Los Angeles, California, United States

San Francisco, California, United States

Santa Barbara, California, United States

Santa Monica, California, United States

Related Publications (1)

Long GV, Dummer R, Hamid O, Gajewski TF, Caglevic C, Dalle S, Arance A, Carlino MS, Grob JJ, Kim TM, Demidov L, Robert C, Larkin J, Anderson JR, Maleski J, Jones M, Diede SJ, Mitchell TC. 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. Lancet Oncol. 2019 Aug;20(8):1083-1097. doi: 10.1016/S1470-2045(19)30274-8. Epub 2019 Jun 17.
PMID: 31221619DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumabepacadostat

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title: Study Director
Organization: Incyte Corporation

Study Officials

Mark Jones, MD
Incyte Corporation
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

706 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 26, 2016

Study Start

June 21, 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Pembrolizumab + Epacadostat

Pembrolizumab + Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (129)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations