Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02752074




Registration number
NCT02752074
Ethics application status
Date submitted
22/04/2016
Date registered
26/04/2016
Date last updated
27/08/2020

Titles & IDs
Public title
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Scientific 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)
Secondary ID [1] 0 0
INCB 24360-301 (ECHO-301)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pembrolizumab + epacadostat
Treatment: Drugs - pembrolizumab + placebo

Experimental: Pembrolizumab + Epacadostat - Pembrolizumab + Epacadostat

Active Comparator: Pembrolizumab + Placebo - Pembrolizumab + Placebo


Treatment: Drugs: pembrolizumab + epacadostat
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)

Treatment: Drugs: pembrolizumab + placebo
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Primary outcome [2] 0 0
Overall Survival (OS) Rate at 6 Months
Timepoint [2] 0 0
Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Secondary outcome [2] 0 0
Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events
Timepoint [2] 0 0
Through up to 90 days after end of treatment, up to 27 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Secondary outcome [4] 0 0
Apparent Oral Clearance (CL/F) of Epacadostat
Timepoint [4] 0 0
Through up to 30 days after the end of treatment, up to 25 months
Secondary outcome [5] 0 0
Apparent Volume of Distribution (Vd/F) of Epacadostat
Timepoint [5] 0 0
Through up to 30 days after the end of treatment, up to 25 months
Secondary outcome [6] 0 0
Clearance (CL) of Pembrolizumab
Timepoint [6] 0 0
Through up to 30 days after the end of treatment, up to 25 months
Secondary outcome [7] 0 0
Volume of Distribution (V) of Pembrolizumab
Timepoint [7] 0 0
Through up to 30 days after the end of treatment, up to 25 months
Secondary outcome [8] 0 0
Formation of Anti-pembrolizumab Antibodies
Timepoint [8] 0 0
Through up to 30 days after the end of treatment, up to 25 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2019
Sample size
Target
Accrual to date
Final
706
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Westmead
Recruitment hospital [3] 0 0
- Wollstonecraft
Recruitment hospital [4] 0 0
- Cairns
Recruitment hospital [5] 0 0
- Greenslopes
Recruitment hospital [6] 0 0
- Kurralta Park
Recruitment hospital [7] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Wollstonecraft
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Greenslopes
Recruitment postcode(s) [6] 0 0
- Kurralta Park
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Chile
State/province [31] 0 0
Santiago
Country [32] 0 0
Chile
State/province [32] 0 0
Vina del Mar
Country [33] 0 0
Denmark
State/province [33] 0 0
Aarhus
Country [34] 0 0
Denmark
State/province [34] 0 0
Herlev
Country [35] 0 0
Denmark
State/province [35] 0 0
Odense C
Country [36] 0 0
France
State/province [36] 0 0
Bordeaux
Country [37] 0 0
France
State/province [37] 0 0
Lille
Country [38] 0 0
France
State/province [38] 0 0
Marseille
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Pierre Benite
Country [41] 0 0
France
State/province [41] 0 0
Reims
Country [42] 0 0
France
State/province [42] 0 0
Rennes
Country [43] 0 0
France
State/province [43] 0 0
Toulouse
Country [44] 0 0
France
State/province [44] 0 0
Villejuif
Country [45] 0 0
Germany
State/province [45] 0 0
Buxtehude
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Hannover
Country [48] 0 0
Germany
State/province [48] 0 0
Kiel
Country [49] 0 0
Germany
State/province [49] 0 0
Tuebingen
Country [50] 0 0
Ireland
State/province [50] 0 0
Cork
Country [51] 0 0
Ireland
State/province [51] 0 0
Dublin
Country [52] 0 0
Ireland
State/province [52] 0 0
Galway
Country [53] 0 0
Israel
State/province [53] 0 0
Ramat Gan
Country [54] 0 0
Italy
State/province [54] 0 0
Bergamo
Country [55] 0 0
Italy
State/province [55] 0 0
Genova
Country [56] 0 0
Italy
State/province [56] 0 0
Milano
Country [57] 0 0
Italy
State/province [57] 0 0
Napoli
Country [58] 0 0
Italy
State/province [58] 0 0
Padova
Country [59] 0 0
Italy
State/province [59] 0 0
Siena
Country [60] 0 0
Japan
State/province [60] 0 0
Sunto-gun
Country [61] 0 0
Japan
State/province [61] 0 0
Asahikawa
Country [62] 0 0
Japan
State/province [62] 0 0
Chuo
Country [63] 0 0
Japan
State/province [63] 0 0
Fukuoka
Country [64] 0 0
Japan
State/province [64] 0 0
Kagoshima
Country [65] 0 0
Japan
State/province [65] 0 0
Kumamoto
Country [66] 0 0
Japan
State/province [66] 0 0
Kurume
Country [67] 0 0
Japan
State/province [67] 0 0
Kyoto
Country [68] 0 0
Japan
State/province [68] 0 0
Matsumoto
Country [69] 0 0
Japan
State/province [69] 0 0
Nagoya
Country [70] 0 0
Japan
State/province [70] 0 0
Niigata
Country [71] 0 0
Japan
State/province [71] 0 0
Okayama
Country [72] 0 0
Japan
State/province [72] 0 0
Osaka
Country [73] 0 0
Japan
State/province [73] 0 0
Sapporo
Country [74] 0 0
Japan
State/province [74] 0 0
Sendai
Country [75] 0 0
Japan
State/province [75] 0 0
Tokyo
Country [76] 0 0
Japan
State/province [76] 0 0
Tsukuba
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Mexico
State/province [78] 0 0
Chihuahua
Country [79] 0 0
Mexico
State/province [79] 0 0
Distrito Federal
Country [80] 0 0
Mexico
State/province [80] 0 0
Mexico City
Country [81] 0 0
Mexico
State/province [81] 0 0
Monterrey
Country [82] 0 0
Netherlands
State/province [82] 0 0
Amsterdam
Country [83] 0 0
Netherlands
State/province [83] 0 0
Nijmegen
Country [84] 0 0
New Zealand
State/province [84] 0 0
Dunedin
Country [85] 0 0
New Zealand
State/province [85] 0 0
Tauranga
Country [86] 0 0
Poland
State/province [86] 0 0
Warszawa
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Istra
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Moscow
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Saint Petersburg
Country [90] 0 0
South Africa
State/province [90] 0 0
Gauteng
Country [91] 0 0
South Africa
State/province [91] 0 0
Pretoria
Country [92] 0 0
South Africa
State/province [92] 0 0
Western Cape
Country [93] 0 0
South Africa
State/province [93] 0 0
Kraaifontein
Country [94] 0 0
Spain
State/province [94] 0 0
Guipuzcoa
Country [95] 0 0
Spain
State/province [95] 0 0
A Coruna
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Pamplona
Country [99] 0 0
Spain
State/province [99] 0 0
San Sebastian
Country [100] 0 0
Spain
State/province [100] 0 0
Sevilla
Country [101] 0 0
Spain
State/province [101] 0 0
Valencia
Country [102] 0 0
Sweden
State/province [102] 0 0
Göteborg
Country [103] 0 0
Sweden
State/province [103] 0 0
Lund
Country [104] 0 0
Sweden
State/province [104] 0 0
Stockholm
Country [105] 0 0
Sweden
State/province [105] 0 0
Uppsala
Country [106] 0 0
Switzerland
State/province [106] 0 0
ZH
Country [107] 0 0
Switzerland
State/province [107] 0 0
Geneve
Country [108] 0 0
Switzerland
State/province [108] 0 0
Lausanne
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Edinburgh
Country [110] 0 0
United Kingdom
State/province [110] 0 0
London
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT02752074
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Jones, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02752074