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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03260894




Registration number
NCT03260894
Ethics application status
Date submitted
22/08/2017
Date registered
24/08/2017

Titles & IDs
Public title
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Scientific title
A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)
Secondary ID [1] 0 0
2017-002259-26
Secondary ID [2] 0 0
KEYNOTE-679/ECHO-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma (RCC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

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

Experimental: Pembrolizumab + Epacadostat -

Active comparator: SoC (Sunitinib or Pazopanib) - Standard of care (SoC) (sunitinib or pazopanib monotherapy).


Treatment: Drugs: Pembrolizumab
Pembrolizumab 200 mg administered intravenously every 3 weeks.

Treatment: Drugs: Epacadostat
Epacadostat 100 mg administered orally twice daily.

Treatment: Drugs: Sunitinib
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.

Treatment: Drugs: Pazopanib
Pazopanib 800 mg administered orally once 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 + Epacadostat Versus Standard of Care (SOC)
Timepoint [1] 0 0
Minimum up to 6 months
Secondary outcome [1] 0 0
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
Secondary outcome [2] 0 0
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Timepoint [2] 0 0
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.

Eligibility
Key inclusion criteria
* Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
* Must not have received any prior systemic therapy for their mRCC.
* Measurable disease based on RECIST v1.1.
* Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
* Karnofsky performance status = 70%.
* 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
* Use of protocol-defined prior/concomitant therapy.
* Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
* History of severe hypersensitivity reaction to study treatments or their excipients.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Known additional malignancy that has progressed or has required active treatment in the last 3 years.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
* History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
* Significant cardiac event within 12 months before Cycle 1 Day 1.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Cabrini Health - Malvern
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Georgia
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United States of America
State/province [5] 0 0
Illinois
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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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Nebraska
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Brazil
State/province [15] 0 0
Florianopolis
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Brazil
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Sao Paulo
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Brazil
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Belo Horizonte
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Brazil
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Porto Alegre
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Region De Los Lagos
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Chile
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Santiago
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Chile
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Vina del Mar
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France
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Cedex 2
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France
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Besançon
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France
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Bordeaux
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France
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Caen
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France
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Hyeres
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France
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Paris
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France
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Pierre Benite
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France
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Strasbourg
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Hannover
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Jena
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Germany
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Magdeburg
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Germany
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Tuebingen
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Hungary
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Pest
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Hungary
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Pozva
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Hungary
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Kaposvar
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Hungary
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Miskolc
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Szolnok
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Hungary
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Szombathely
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Ireland
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Dublin
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Ireland
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Waterford
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Arezzo
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Brescia
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Milano
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Aichi
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Chiba
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Nara
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Saitama
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Yamaguchi
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Akita
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Fukuoka
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Niigata
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Tokyo
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Korea, Republic of
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Jeollanam Do
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Korea, Republic of
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Seoul
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New Zealand
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Grafton
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Bergen
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Gralum
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Kristiansand
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Lørenskog
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Oslo
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Norway
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Tromsø
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Norway
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Trondheim
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Russian Federation
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Leningrad Region, Vsevolozhsky District
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Ufa
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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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Santiago de Compostela
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
State/province [89] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
Country [93] 0 0
Turkey
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Tekirdag
Country [94] 0 0
Ukraine
State/province [94] 0 0
Dnipropetrovsk Region
Country [95] 0 0
Ukraine
State/province [95] 0 0
Dnipropetrovs'k
Country [96] 0 0
Ukraine
State/province [96] 0 0
Ivano-Frankivs'k
Country [97] 0 0
Ukraine
State/province [97] 0 0
Sumy
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Surrey
Country [99] 0 0
United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
Country [101] 0 0
United Kingdom
State/province [101] 0 0
London
Country [102] 0 0
United Kingdom
State/province [102] 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
Trial website
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

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/NCT03260894