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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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.
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 - 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.
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) - 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.
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 - Safety and tolerability, as assessed by percentage of participants with adverse events and changes in laboratory parameters.
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) - 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.
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 - Defined as oral dose clearance.
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 - Apparent volume of distribution after administration.
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 - Evaluate the measurement of anti-drug antibodies (ADA).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Alabama
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Michigan
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Geneve
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Edinburgh
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London
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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 Corp.
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/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
Other publications