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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03322540




Registration number
NCT03322540
Ethics application status
Date submitted
24/10/2017
Date registered
26/10/2017
Date last updated
24/01/2022

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
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
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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
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Canada
State/province [12] 0 0
New Brunswick
Country [13] 0 0
Canada
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Ontario
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Denmark
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Copenhagen
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Denmark
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Herning
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Denmark
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Odense
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Estonia
State/province [17] 0 0
Tartu
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Ireland
State/province [18] 0 0
Connacht
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Ireland
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Dublin
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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
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Italy
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Roma
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Japan
State/province [27] 0 0
Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Ishikawa
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Japan
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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
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Japan
State/province [36] 0 0
Okayama
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Japan
State/province [37] 0 0
Tokyo
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Japan
State/province [38] 0 0
Wakayama
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Korea, Republic of
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Chungcheongbuk Do
Country [40] 0 0
Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Malaysia
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Pahang
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Malaysia
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Wilayah Persekutuan
Country [44] 0 0
Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Poland
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Swietokrzyskie
Country [47] 0 0
Poland
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Bydgoszcz
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Poland
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Gliwice
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Poland
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Kielce
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Poland
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Konin
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Poland
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Olsztyn
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Poland
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Tarnobrzeg
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Poland
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Warszawa
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Russian Federation
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Belgorod
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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Ufa
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Spain
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Pontevedra
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Bellinzona
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Switzerland
State/province [66] 0 0
Bern
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Switzerland
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Geneva
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Switzerland
State/province [68] 0 0
Winterthur
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Switzerland
State/province [69] 0 0
Zuerich
Country [70] 0 0
Turkey
State/province [70] 0 0
Adana
Country [71] 0 0
Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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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
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Ukraine
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Kharkiv
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Ukraine
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Kirovohrad
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Ukraine
State/province [79] 0 0
Kyiv
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Ukraine
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Lutsk
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Ukraine
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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
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus
epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants
with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell
death ligand 1 (PD-L1).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03322540
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03322540