Clinical trial NCT02752074: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Keywords: Melanoma
Metastatic Melanoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-04-26
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
measure: Overall Survival (OS) Rate at 6 Months
timeFrame: Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
measure: Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events
timeFrame: Through up to 90 days after end of treatment, up to 27 months
measure: Duration of Response (DOR)
timeFrame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
measure: Apparent Oral Clearance (CL/F) of Epacadostat
timeFrame: Through up to 30 days after the end of treatment, up to 25 months
measure: Apparent Volume of Distribution (Vd/F) of Epacadostat
timeFrame: Through up to 30 days after the end of treatment, up to 25 months
measure: Clearance (CL) of Pembrolizumab
timeFrame: Through up to 30 days after the end of treatment, up to 25 months
measure: Volume of Distribution (V) of Pembrolizumab
timeFrame: Through up to 30 days after the end of treatment, up to 25 months
measure: Formation of Anti-pembrolizumab Antibodies
timeFrame: Through up to 30 days after the end of treatment, up to 25 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lutherville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Camperdown
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Wollstonecraft
country: Australia
state: New South Wales
city: Cairns
country: Australia
state: Queensland
city: Greenslopes
country: Australia
state: Queensland
city: Kurralta Park
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: North Vancouver
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Vina del Mar
country: Chile
city: Aarhus
country: Denmark
city: Herlev
country: Denmark
city: Odense C
country: Denmark
city: Bordeaux
country: France
city: Lille
country: France
city: Marseille
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Reims
country: France
city: Rennes
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Buxtehude
country: Germany
city: Essen
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Tuebingen
country: Germany
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Galway
country: Ireland
city: Ramat Gan
country: Israel
city: Bergamo
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Siena
country: Italy
city: Susono
country: Japan
state: Sunto-gun
city: Asahikawa
country: Japan
city: Chuo
country: Japan
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Kurume
country: Japan
city: Kyoto
country: Japan
city: Matsumoto
country: Japan
city: Nagoya
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Tokyo
country: Japan
city: Tsukuba
country: Japan
city: Seoul
country: Korea, Republic of
city: Chihuahua
country: Mexico
city: Distrito Federal
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Amsterdam
country: Netherlands
city: Nijmegen
country: Netherlands
city: Dunedin
country: New Zealand
city: Tauranga
country: New Zealand
city: Warszawa
country: Poland
city: Istra
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Johannesburg
country: South Africa
state: Gauteng
city: Sandton
country: South Africa
state: Gauteng
city: Groenkloof
country: South Africa
state: Pretoria
city: Cape Town
country: South Africa
state: Western Cape
city: Kraaifontein
country: South Africa
city: Donostia-San Sebastian
country: Spain
state: Guipuzcoa
city: A Coruna
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: San Sebastian
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Zürich
country: Switzerland
state: ZH
city: Geneve
country: Switzerland
city: Lausanne
country: Switzerland
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Incyte Corporation
name: Mark Jones, MD
role: STUDY_DIRECTOR
References:
citation: 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.