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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03142334
Ethics application status
Date submitted
3/05/2017
Date registered
5/05/2017
Date last updated
28/05/2020

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 III, 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
2016-004351-75
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
Other interventions - Pembrolizumab
Treatment: Drugs - Placebo (saline solution)

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

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


Other interventions: Pembrolizumab
IV infusion

Treatment: Drugs: Placebo (saline solution)
IV infusion

Intervention code [1] 0 0
Other interventions
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 - DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.
Timepoint [1] 0 0
Up to approximately 50 months
Secondary outcome [1] 0 0
Overall Survival (OS) - OS is defined as the time from randomization to death due to any cause.
Timepoint [1] 0 0
Up to approximately 72 months
Secondary outcome [2] 0 0
Number of Participants Who Experienced an Adverse Event (AE) - An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants are monitored for the occurrence of nonserious AEs for up to 30 days after last dose of study treatment and of serious AEs for up to 90 days after last dose of study treatment. The number of participants who experience an AE will be assessed.
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 - An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinue study treatment due to an AE will be assessed.
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 - DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
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 - DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, 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) - EFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first.
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 - DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.
Timepoint [7] 0 0
Up to approximately 72 months
Secondary outcome [8] 0 0
OS According to Participant PD-L1 Expression Status (Positive, Negative) - OS is defined as the time from randomization to death due to any cause.
Timepoint [8] 0 0
Up to approximately 72 months
Secondary outcome [9] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score - The QLQ-C30 quality of life (QOL) questionnaire contains 5 functioning scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain) and single symptom items (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Items are scored on a 4-point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much). The QLQC30 also contains 2 global health status scales that use 7-point scale scoring (1=very poor and 7=excellent). The change from baseline in the 2-item global health status/QOL life scale (range: 2-14) will be presented, with a higher score representing a higher QOL.
Timepoint [9] 0 0
Baseline and Cycles 1, 5, 9, 13, and 17, treatment discontinuation, 30 day follow up, and annually during post-treatment follow up. Each cycle is 3 weeks long. (Up to approximately 72 months)
Secondary outcome [10] 0 0
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score - The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer over the previous 7 days. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status.
Timepoint [10] 0 0
Baseline and Cycles 1, 5, 9, 13, and 17, treatment discontinuation, 30 day follow up, and annually during post-treatment follow up. Each cycle is 3 weeks long. (Up to approximately 72 months)

Eligibility
Key inclusion criteria
- Has histologically confirmed diagnosis of 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 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
Gender
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-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
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)
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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Aichi
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Fukuoka
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Kumamoto
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Tokyo
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Bytom
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Gdynia
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Konin
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Krakow
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Lublin
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Otwock
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Poznan
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Torun
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Russian Federation
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Ivanovo
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Saint Petersburg
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Tomsk
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Ufa
Country [156] 0 0
Spain
State/province [156] 0 0
Badajoz
Country [157] 0 0
Spain
State/province [157] 0 0
Barcelona
Country [158] 0 0
Spain
State/province [158] 0 0
Girona
Country [159] 0 0
Spain
State/province [159] 0 0
Madrid
Country [160] 0 0
Spain
State/province [160] 0 0
Malaga
Country [161] 0 0
Spain
State/province [161] 0 0
Pamplona
Country [162] 0 0
Spain
State/province [162] 0 0
Valencia
Country [163] 0 0
Taiwan
State/province [163] 0 0
Taichung
Country [164] 0 0
Taiwan
State/province [164] 0 0
Taipei
Country [165] 0 0
Taiwan
State/province [165] 0 0
Taoyuan
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Staffordshire
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Edinburgh
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Glasgow
Country [169] 0 0
United Kingdom
State/province [169] 0 0
London
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Manchester
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475)
in the adjuvant treatment of adult participants who have undergone nephrectomy and have
intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma
(RCC) with clear cell component.

The primary study hypothesis is that pembrolizumab is superior to placebo with respect to
Disease-free Survival (DFS) as assessed by the Investigator in male and female participants
with intermediate-high risk, high risk and M1 NED RCC.
Trial website
https://clinicaltrials.gov/show/NCT03142334
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
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