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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03142334




Registration number
NCT03142334
Ethics application status
Date submitted
3/05/2017
Date registered
5/05/2017

Titles & IDs
Public title
Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
Secondary ID [1] 0 0
173704
Secondary ID [2] 0 0
3475-564
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 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: Other - Pembrolizumab
Treatment: Drugs - Placebo

Experimental: Pembrolizumab - Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).

Placebo comparator: Placebo - Participants receive placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS) as Assessed by the Investigator
Timepoint [1] 0 0
Up to approximately 42 months (database cutoff date 14 Dec 2020)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 72 months
Secondary outcome [2] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [2] 0 0
Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
Secondary outcome [3] 0 0
Number of Participants Who Discontinued Study Drug Due to an AE
Timepoint [3] 0 0
Up to approximately 12 months
Secondary outcome [4] 0 0
First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
Timepoint [4] 0 0
Up to approximately 72 months
Secondary outcome [5] 0 0
Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator
Timepoint [5] 0 0
Up to approximately 72 months
Secondary outcome [6] 0 0
Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR)
Timepoint [6] 0 0
Up to approximately 72 months
Secondary outcome [7] 0 0
DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
Timepoint [7] 0 0
Up to approximately 72 months
Secondary outcome [8] 0 0
OS According to Participant PD-L1 Expression Status (Positive, Negative)
Timepoint [8] 0 0
Up to approximately 72 months
Secondary outcome [9] 0 0
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
Timepoint [10] 0 0
Baseline and Week 52

Eligibility
Key inclusion criteria
* Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
* Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment
* Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment
* Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:

1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0
2. High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0
3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, =1 year from nephrectomy (metachronous)
* Has received no prior systemic therapy for advanced RCC
* Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins
* Must have undergone a nephrectomy and/or metastasectomy =28 days prior to signing informed consent and =12 weeks prior to randomization
* Must be tumor-free as assessed by the Investigator and validated by either computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and chest, abdomen, and pelvis and a bone scan =28 days from randomization
* Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available)
* Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
* Has adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization
* Has received prior radiotherapy for RCC
* Has pre-existing brain or bone metastatic lesions
* Has residual thrombus post nephrectomy in the vena renalis or vena cava
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed
* Has a known additional malignancy that is progressing or required active treatment =3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a history of, or is currently on, dialysis
* Has a known history of human immunodeficiency virus (HIV) infection
* Has known active hepatitis B or hepatitis C virus infection
* Has a known history of active tuberculosis (Bacillus tuberculosis)
* Has had a prior solid organ transplant
* Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 120 days after the last dose of study treatment
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
* Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (i.e., must be = Grade 1 or at Baseline) from AEs due to previously administered agents
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

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 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
9/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/12/2025
Actual
Sample size
Target
Accrual to date
Final
994
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Saint George Hospital [Kogarah, Australia] ( Site 0707) - Kogarah
Recruitment hospital [2] 0 0
Macquarie University Hospital ( Site 0700) - Macquarie Park
Recruitment hospital [3] 0 0
Adelaide Cancer Centre ( Site 0703) - Kurralta Park
Recruitment hospital [4] 0 0
Bendigo Cancer Centre ( Site 0704) - Bendigo
Recruitment hospital [5] 0 0
Box Hill Hospital ( Site 0701) - Box Hill
Recruitment hospital [6] 0 0
Fiona Stanley Hospital ( Site 0702) - Murdoch
Recruitment hospital [7] 0 0
Ballarat Health Services ( Site 0705) - Ballarat
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3550 - Bendigo
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment outside Australia
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United States of America
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Arizona
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California
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Russian Federation
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Tomsk
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Ufa
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Madrid
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Malaga
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Pamplona
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Spain
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Valencia
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Staffordshire
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United Kingdom
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Edinburgh
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Glasgow
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferg... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03142334