Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
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
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Brazil
State/province [15] 0 0
Florianopolis
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
Belo Horizonte
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Chile
State/province [22] 0 0
Region De Los Lagos
Country [23] 0 0
Chile
State/province [23] 0 0
Santiago
Country [24] 0 0
Chile
State/province [24] 0 0
Vina del Mar
Country [25] 0 0
France
State/province [25] 0 0
Cedex 2
Country [26] 0 0
France
State/province [26] 0 0
Besançon
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Caen
Country [29] 0 0
France
State/province [29] 0 0
Hyeres
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Pierre Benite
Country [32] 0 0
France
State/province [32] 0 0
Strasbourg
Country [33] 0 0
France
State/province [33] 0 0
Villejuif
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Dresden
Country [36] 0 0
Germany
State/province [36] 0 0
Essen
Country [37] 0 0
Germany
State/province [37] 0 0
Frankfurt am Main
Country [38] 0 0
Germany
State/province [38] 0 0
Hannover
Country [39] 0 0
Germany
State/province [39] 0 0
Jena
Country [40] 0 0
Germany
State/province [40] 0 0
Magdeburg
Country [41] 0 0
Germany
State/province [41] 0 0
Tuebingen
Country [42] 0 0
Hungary
State/province [42] 0 0
Pest
Country [43] 0 0
Hungary
State/province [43] 0 0
Pozva
Country [44] 0 0
Hungary
State/province [44] 0 0
Kaposvar
Country [45] 0 0
Hungary
State/province [45] 0 0
Miskolc
Country [46] 0 0
Hungary
State/province [46] 0 0
Szolnok
Country [47] 0 0
Hungary
State/province [47] 0 0
Szombathely
Country [48] 0 0
Ireland
State/province [48] 0 0
Dublin
Country [49] 0 0
Ireland
State/province [49] 0 0
Waterford
Country [50] 0 0
Italy
State/province [50] 0 0
Arezzo
Country [51] 0 0
Italy
State/province [51] 0 0
Brescia
Country [52] 0 0
Italy
State/province [52] 0 0
Milano
Country [53] 0 0
Italy
State/province [53] 0 0
Napoli
Country [54] 0 0
Italy
State/province [54] 0 0
Pavia
Country [55] 0 0
Italy
State/province [55] 0 0
Roma
Country [56] 0 0
Japan
State/province [56] 0 0
Aichi
Country [57] 0 0
Japan
State/province [57] 0 0
Chiba
Country [58] 0 0
Japan
State/province [58] 0 0
Hokkaido
Country [59] 0 0
Japan
State/province [59] 0 0
Nara
Country [60] 0 0
Japan
State/province [60] 0 0
Osaka
Country [61] 0 0
Japan
State/province [61] 0 0
Saitama
Country [62] 0 0
Japan
State/province [62] 0 0
Yamaguchi
Country [63] 0 0
Japan
State/province [63] 0 0
Akita
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Niigata
Country [66] 0 0
Japan
State/province [66] 0 0
Tokyo
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Jeollanam Do
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
Country [69] 0 0
New Zealand
State/province [69] 0 0
Grafton
Country [70] 0 0
Norway
State/province [70] 0 0
Bergen
Country [71] 0 0
Norway
State/province [71] 0 0
Gralum
Country [72] 0 0
Norway
State/province [72] 0 0
Kristiansand
Country [73] 0 0
Norway
State/province [73] 0 0
Lørenskog
Country [74] 0 0
Norway
State/province [74] 0 0
Oslo
Country [75] 0 0
Norway
State/province [75] 0 0
Tromsø
Country [76] 0 0
Norway
State/province [76] 0 0
Trondheim
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Leningrad Region, Vsevolozhsky District
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Ivanovo
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Ufa
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Santiago de Compostela
Country [84] 0 0
Spain
State/province [84] 0 0
Valencia
Country [85] 0 0
Taiwan
State/province [85] 0 0
Kaohsiung
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taichung
Country [87] 0 0
Taiwan
State/province [87] 0 0
Tainan
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taipei
Country [89] 0 0
Turkey
State/province [89] 0 0
Adana
Country [90] 0 0
Turkey
State/province [90] 0 0
Ankara
Country [91] 0 0
Turkey
State/province [91] 0 0
Istanbul
Country [92] 0 0
Turkey
State/province [92] 0 0
Izmir
Country [93] 0 0
Turkey
State/province [93] 0 0
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
State/province [99] 0 0
Edinburgh
Country [100] 0 0
United Kingdom
State/province [100] 0 0
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 not provided in https://clinicaltrials.gov/study/NCT03260894