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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03260894
Ethics application status
Date submitted
22/08/2017
Date registered
24/08/2017
Date last updated
30/10/2019

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) - ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
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) - AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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 - AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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
Gender
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
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)
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
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United States of America
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Arizona
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Utah
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Florianopolis
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Chile
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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 this study was to evaluate the efficacy and safety of pembrolizumab plus
epacadostat compared to sunitinib or pazopanib in participants with locally
advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not
received prior systemic therapy for their mRCC.
Trial website
https://clinicaltrials.gov/show/NCT03260894
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