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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02752074
Registration number
NCT02752074
Ethics application status
Date submitted
22/04/2016
Date registered
26/04/2016
Titles & IDs
Public title
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
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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)
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Secondary ID [1]
0
0
INCB 24360-301 (ECHO-301)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Progression-free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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0
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
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Primary outcome [2]
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0
Overall Survival (OS) Rate at 6 Months
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Assessment method [2]
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0
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.
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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.
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Secondary outcome [1]
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0
Objective Response Rate (ORR)
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Assessment method [1]
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0
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.
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Timepoint [1]
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0
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
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Secondary outcome [2]
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Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events
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Assessment method [2]
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Safety and tolerability, as assessed by percentage of participants with adverse events and changes in laboratory parameters.
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Timepoint [2]
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Through up to 90 days after end of treatment, up to 27 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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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.
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Timepoint [3]
0
0
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
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Secondary outcome [4]
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0
Apparent Oral Clearance (CL/F) of Epacadostat
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Assessment method [4]
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Defined as oral dose clearance.
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Timepoint [4]
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0
Through up to 30 days after the end of treatment, up to 25 months
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Secondary outcome [5]
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Apparent Volume of Distribution (Vd/F) of Epacadostat
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Assessment method [5]
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0
Apparent volume of distribution after administration.
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Timepoint [5]
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0
Through up to 30 days after the end of treatment, up to 25 months
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Secondary outcome [6]
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Clearance (CL) of Pembrolizumab
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Assessment method [6]
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0
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Timepoint [6]
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0
Through up to 30 days after the end of treatment, up to 25 months
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Secondary outcome [7]
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Volume of Distribution (V) of Pembrolizumab
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Assessment method [7]
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0
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Timepoint [7]
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Through up to 30 days after the end of treatment, up to 25 months
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Secondary outcome [8]
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Formation of Anti-pembrolizumab Antibodies
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Assessment method [8]
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Evaluate the measurement of anti-drug antibodies (ADA).
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Timepoint [8]
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Through up to 30 days after the end of treatment, up to 25 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/08/2019
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Sample size
Target
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Accrual to date
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Final
706
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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- Camperdown
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- Westmead
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- Kurralta Park
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- Melbourne
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- Melbourne
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Other collaborator category [1]
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Merck Sharp & Dohme LLC
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT02752074
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Mark Jones, MD
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Incyte Corporation
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/74/NCT02752074/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/74/NCT02752074/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02752074