Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT03142334




Registration number
NCT03142334
Ethics application status
Date submitted
3/05/2017
Date registered
5/05/2017
Date last updated
13/11/2024

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
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
Rio Negro
Country [34] 0 0
Argentina
State/province [34] 0 0
Santa Fe
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
La Rioja
Country [37] 0 0
Argentina
State/province [37] 0 0
Mendoza
Country [38] 0 0
Argentina
State/province [38] 0 0
Rosario
Country [39] 0 0
Argentina
State/province [39] 0 0
Tucuman
Country [40] 0 0
Brazil
State/province [40] 0 0
PR
Country [41] 0 0
Brazil
State/province [41] 0 0
Rio Grande Do Norte
Country [42] 0 0
Brazil
State/province [42] 0 0
Rio Grande Do Sul
Country [43] 0 0
Brazil
State/province [43] 0 0
RS
Country [44] 0 0
Brazil
State/province [44] 0 0
Sao Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
SP
Country [46] 0 0
Brazil
State/province [46] 0 0
Ribeirao Preto
Country [47] 0 0
Brazil
State/province [47] 0 0
Uberlandia
Country [48] 0 0
Canada
State/province [48] 0 0
Manitoba
Country [49] 0 0
Canada
State/province [49] 0 0
New Brunswick
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Canada
State/province [52] 0 0
Saskatchewan
Country [53] 0 0
Chile
State/province [53] 0 0
Region Metropolitana
Country [54] 0 0
Chile
State/province [54] 0 0
Antofagasta
Country [55] 0 0
Chile
State/province [55] 0 0
La Serena
Country [56] 0 0
Chile
State/province [56] 0 0
Rancagua
Country [57] 0 0
Chile
State/province [57] 0 0
Santiago
Country [58] 0 0
Chile
State/province [58] 0 0
Temuco
Country [59] 0 0
Chile
State/province [59] 0 0
Vina del Mar
Country [60] 0 0
Colombia
State/province [60] 0 0
Antioquia
Country [61] 0 0
Colombia
State/province [61] 0 0
Atlantico
Country [62] 0 0
Colombia
State/province [62] 0 0
Cesar
Country [63] 0 0
Colombia
State/province [63] 0 0
Cundinamarca
Country [64] 0 0
Colombia
State/province [64] 0 0
Risaralda
Country [65] 0 0
Colombia
State/province [65] 0 0
Bogota
Country [66] 0 0
Colombia
State/province [66] 0 0
Monteria
Country [67] 0 0
Czechia
State/province [67] 0 0
Brno
Country [68] 0 0
Czechia
State/province [68] 0 0
Novy Jicin
Country [69] 0 0
Czechia
State/province [69] 0 0
Olomouc
Country [70] 0 0
Czechia
State/province [70] 0 0
Ostrava
Country [71] 0 0
Czechia
State/province [71] 0 0
Praha 4
Country [72] 0 0
Czechia
State/province [72] 0 0
Praha 5
Country [73] 0 0
Czechia
State/province [73] 0 0
Praha 8
Country [74] 0 0
Finland
State/province [74] 0 0
Helsinki
Country [75] 0 0
Finland
State/province [75] 0 0
Jyvaskyla
Country [76] 0 0
Finland
State/province [76] 0 0
Oulu
Country [77] 0 0
Finland
State/province [77] 0 0
Tampere
Country [78] 0 0
Finland
State/province [78] 0 0
Turku
Country [79] 0 0
France
State/province [79] 0 0
Angers
Country [80] 0 0
France
State/province [80] 0 0
Besancon
Country [81] 0 0
France
State/province [81] 0 0
Bordeaux
Country [82] 0 0
France
State/province [82] 0 0
Marseille
Country [83] 0 0
France
State/province [83] 0 0
Montpellier
Country [84] 0 0
France
State/province [84] 0 0
Nice
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Pierre Benite
Country [87] 0 0
France
State/province [87] 0 0
Rennes
Country [88] 0 0
France
State/province [88] 0 0
Saint Herblain
Country [89] 0 0
France
State/province [89] 0 0
Toulouse
Country [90] 0 0
Germany
State/province [90] 0 0
Berlin
Country [91] 0 0
Germany
State/province [91] 0 0
Bonn
Country [92] 0 0
Germany
State/province [92] 0 0
Dresden
Country [93] 0 0
Germany
State/province [93] 0 0
Dusseldorf
Country [94] 0 0
Germany
State/province [94] 0 0
Erlangen
Country [95] 0 0
Germany
State/province [95] 0 0
Essen
Country [96] 0 0
Germany
State/province [96] 0 0
Frankfurt
Country [97] 0 0
Germany
State/province [97] 0 0
Freiburg
Country [98] 0 0
Germany
State/province [98] 0 0
Hamburg
Country [99] 0 0
Germany
State/province [99] 0 0
Jena
Country [100] 0 0
Germany
State/province [100] 0 0
Luebeck
Country [101] 0 0
Germany
State/province [101] 0 0
Mainz
Country [102] 0 0
Germany
State/province [102] 0 0
Nuertingen
Country [103] 0 0
Germany
State/province [103] 0 0
Trier
Country [104] 0 0
Germany
State/province [104] 0 0
Tuebingen
Country [105] 0 0
Ireland
State/province [105] 0 0
Dublin
Country [106] 0 0
Ireland
State/province [106] 0 0
Waterford
Country [107] 0 0
Italy
State/province [107] 0 0
Torino
Country [108] 0 0
Italy
State/province [108] 0 0
Arezzo
Country [109] 0 0
Italy
State/province [109] 0 0
Meldola
Country [110] 0 0
Italy
State/province [110] 0 0
Milano
Country [111] 0 0
Italy
State/province [111] 0 0
Modena
Country [112] 0 0
Italy
State/province [112] 0 0
Napoli
Country [113] 0 0
Italy
State/province [113] 0 0
Roma
Country [114] 0 0
Japan
State/province [114] 0 0
Aichi
Country [115] 0 0
Japan
State/province [115] 0 0
Hokkaido
Country [116] 0 0
Japan
State/province [116] 0 0
Kagawa
Country [117] 0 0
Japan
State/province [117] 0 0
Miyagi
Country [118] 0 0
Japan
State/province [118] 0 0
Nara
Country [119] 0 0
Japan
State/province [119] 0 0
Osaka
Country [120] 0 0
Japan
State/province [120] 0 0
Saitama
Country [121] 0 0
Japan
State/province [121] 0 0
Yamaguchi
Country [122] 0 0
Japan
State/province [122] 0 0
Akita
Country [123] 0 0
Japan
State/province [123] 0 0
Fukuoka
Country [124] 0 0
Japan
State/province [124] 0 0
Kumamoto
Country [125] 0 0
Japan
State/province [125] 0 0
Nagano
Country [126] 0 0
Japan
State/province [126] 0 0
Niigata
Country [127] 0 0
Japan
State/province [127] 0 0
Tokyo
Country [128] 0 0
Japan
State/province [128] 0 0
Toyama
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Gyeonggi-do
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Seoul
Country [131] 0 0
Netherlands
State/province [131] 0 0
Breda
Country [132] 0 0
Netherlands
State/province [132] 0 0
Maastricht
Country [133] 0 0
Netherlands
State/province [133] 0 0
Rotterdam
Country [134] 0 0
Poland
State/province [134] 0 0
Mazowieckie
Country [135] 0 0
Poland
State/province [135] 0 0
Pomorskie
Country [136] 0 0
Poland
State/province [136] 0 0
Brzozow
Country [137] 0 0
Poland
State/province [137] 0 0
Bytom
Country [138] 0 0
Poland
State/province [138] 0 0
Gdansk
Country [139] 0 0
Poland
State/province [139] 0 0
Gdynia
Country [140] 0 0
Poland
State/province [140] 0 0
Gliwice
Country [141] 0 0
Poland
State/province [141] 0 0
Konin
Country [142] 0 0
Poland
State/province [142] 0 0
Krakow
Country [143] 0 0
Poland
State/province [143] 0 0
Lublin
Country [144] 0 0
Poland
State/province [144] 0 0
Otwock
Country [145] 0 0
Poland
State/province [145] 0 0
Poznan
Country [146] 0 0
Poland
State/province [146] 0 0
Torun
Country [147] 0 0
Poland
State/province [147] 0 0
Warszawa
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Ivanovo
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Krasnoyarsk
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Moscow
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Murmansk
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Omsk
Country [153] 0 0
Russian Federation
State/province [153] 0 0
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 LLC
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/study/NCT03142334
Trial related presentations / publications
Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Chang YH, Lee JL, Sarwar N, Haas NB, Gurney H, Sawrycki P, Mahave M, Gross-Goupil M, Zhang T, Burke JM, Doshi G, Melichar B, Kopyltsov E, Alva A, Oudard S, Topart D, Hammers H, Kitamura H, McDermott DF, Silva A, Winquist E, Cornell J, Elfiky A, Burgents JE, Perini RF, Powles T; KEYNOTE-564 Investigators. Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma. N Engl J Med. 2024 Apr 18;390(15):1359-1371. doi: 10.1056/NEJMoa2312695.
Powles T, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Gurney H, Chang YH, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Burgents JE, Xu L, Imai K, Quinn DI, Choueiri TK; KEYNOTE-564 Investigators. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1133-1144. doi: 10.1016/S1470-2045(22)00487-9. Erratum In: Lancet Oncol. 2023 Jan;24(1):e10. doi: 10.1016/S1470-2045(22)00759-8.
Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Chang YH, Hajek J, Symeonides SN, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Gurney H, Chevreau C, Melichar B, Kopyltsov E, Alva A, Burke JM, Doshi G, Topart D, Oudard S, Hammers H, Kitamura H, Bedke J, Perini RF, Zhang P, Imai K, Willemann-Rogerio J, Quinn DI, Powles T; KEYNOTE-564 Investigators. Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. N Engl J Med. 2021 Aug 19;385(8):683-694. doi: 10.1056/NEJMoa2106391.
Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03142334