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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03322540




Registration number
NCT03322540
Ethics application status
Date submitted
24/10/2017
Date registered
26/10/2017

Titles & IDs
Public title
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
Scientific title
A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1
Secondary ID [1] 0 0
KEYNOTE-654-05/ECHO-305-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Epacadostat
Treatment: Drugs - Placebo

Experimental: Pembrolizumab + Epacadostat - Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.

Active comparator: Pembrolizumab + Placebo - Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.


Treatment: Drugs: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.

Treatment: Drugs: Epacadostat
Epacadostat administered orally twice daily.

Treatment: Drugs: Placebo
Matching placebo administered orally twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
Timepoint [1] 0 0
Up to approximately 6 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Timepoint [1] 0 0
Up to approximately 36 months
Secondary outcome [2] 0 0
Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Timepoint [2] 0 0
Up to approximately 36 months
Secondary outcome [3] 0 0
Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Timepoint [3] 0 0
Up to approximately 36 months
Secondary outcome [4] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [4] 0 0
Up to 37 months
Secondary outcome [5] 0 0
Number of Participants Who Discontinued Study Drug Due to AEs
Timepoint [5] 0 0
Up to 37 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation.
* Measurable disease based on RECIST 1.1.
* Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in = 50% of tumor cells (tumor proportion score [TPS] = 50%) as assessed by immunohistochemistry at a central laboratory.
* Life expectancy of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known untreated central nervous system metastases and/or carcinomatous meningitis.
* History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
* Symptomatic ascites or pleural effusion.
* Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
* Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
* History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
* Use of protocol-defined prior/concomitant therapy.

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 2
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
15/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2020
Sample size
Target
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Austin Health-Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
St John of God Murdoch Medical Clinic - Murdoch
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
New Brunswick
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Denmark
State/province [14] 0 0
Copenhagen
Country [15] 0 0
Denmark
State/province [15] 0 0
Herning
Country [16] 0 0
Denmark
State/province [16] 0 0
Odense
Country [17] 0 0
Estonia
State/province [17] 0 0
Tartu
Country [18] 0 0
Ireland
State/province [18] 0 0
Connacht
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin
Country [20] 0 0
Israel
State/province [20] 0 0
Beer Sheva
Country [21] 0 0
Israel
State/province [21] 0 0
Haifa
Country [22] 0 0
Israel
State/province [22] 0 0
Kfar Saba
Country [23] 0 0
Israel
State/province [23] 0 0
Petah Tikva
Country [24] 0 0
Israel
State/province [24] 0 0
Ramat Gan
Country [25] 0 0
Italy
State/province [25] 0 0
Genova
Country [26] 0 0
Italy
State/province [26] 0 0
Roma
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Ehime
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Ishikawa
Country [31] 0 0
Japan
State/province [31] 0 0
Kanagawa
Country [32] 0 0
Japan
State/province [32] 0 0
Miyagi
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka
Country [34] 0 0
Japan
State/province [34] 0 0
Shizuoka Prefecture
Country [35] 0 0
Japan
State/province [35] 0 0
Niigata
Country [36] 0 0
Japan
State/province [36] 0 0
Okayama
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Japan
State/province [38] 0 0
Wakayama
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Chungcheongbuk Do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gyeonggi-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Incheon
Country [42] 0 0
Malaysia
State/province [42] 0 0
Pahang
Country [43] 0 0
Malaysia
State/province [43] 0 0
Wilayah Persekutuan
Country [44] 0 0
Malaysia
State/province [44] 0 0
Kuala Lumpur
Country [45] 0 0
Malaysia
State/province [45] 0 0
Kuching
Country [46] 0 0
Poland
State/province [46] 0 0
Swietokrzyskie
Country [47] 0 0
Poland
State/province [47] 0 0
Bydgoszcz
Country [48] 0 0
Poland
State/province [48] 0 0
Gliwice
Country [49] 0 0
Poland
State/province [49] 0 0
Kielce
Country [50] 0 0
Poland
State/province [50] 0 0
Konin
Country [51] 0 0
Poland
State/province [51] 0 0
Olsztyn
Country [52] 0 0
Poland
State/province [52] 0 0
Tarnobrzeg
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Belgorod
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Moscow
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Samara
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Ufa
Country [59] 0 0
Spain
State/province [59] 0 0
Pontevedra
Country [60] 0 0
Spain
State/province [60] 0 0
Alicante
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
Switzerland
State/province [65] 0 0
Bellinzona
Country [66] 0 0
Switzerland
State/province [66] 0 0
Bern
Country [67] 0 0
Switzerland
State/province [67] 0 0
Geneva
Country [68] 0 0
Switzerland
State/province [68] 0 0
Winterthur
Country [69] 0 0
Switzerland
State/province [69] 0 0
Zuerich
Country [70] 0 0
Turkey
State/province [70] 0 0
Adana
Country [71] 0 0
Turkey
State/province [71] 0 0
Ankara
Country [72] 0 0
Turkey
State/province [72] 0 0
Antalya
Country [73] 0 0
Turkey
State/province [73] 0 0
Kayseri
Country [74] 0 0
Turkey
State/province [74] 0 0
Konya
Country [75] 0 0
Ukraine
State/province [75] 0 0
Dnipropetrovsk Region
Country [76] 0 0
Ukraine
State/province [76] 0 0
Dnipropetrovsk
Country [77] 0 0
Ukraine
State/province [77] 0 0
Kharkiv
Country [78] 0 0
Ukraine
State/province [78] 0 0
Kirovohrad
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kyiv
Country [80] 0 0
Ukraine
State/province [80] 0 0
Lutsk
Country [81] 0 0
Ukraine
State/province [81] 0 0
Odesa
Country [82] 0 0
Ukraine
State/province [82] 0 0
Zaporizhzhya
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Leeds

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lance Leopold, 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03322540