Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03142334
Recruitment Status : Active, not recruiting
First Posted : May 5, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.


Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Pembrolizumab Drug: Placebo (saline solution) Phase 3

Detailed Description:
Participants will be assigned to receive study treatment until disease recurrence, unacceptable adverse events (AEs), intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the participant, noncompliance with study treatment or procedural requirements, administrative reasons requiring cessation of treatment, or until the participant has received 17 cycles of study treatment (approximately 1 year). Each cycle is 3 weeks long.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : November 12, 2022
Estimated Study Completion Date : December 28, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles.
Biological: Pembrolizumab
IV infusion
Other Name: MK-3475

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




Primary Outcome Measures :
  1. Disease-free Survival (DFS) as Assessed by the Investigator [ Time Frame: Up to approximately 72 months ]
    DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 72 months ]
    OS is defined as the time from randomization to death due to any cause.

  2. Adverse Events (AEs) [ Time Frame: 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) ]
    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.

  3. Study Treatment Discontinuations Due to an AE [ Time Frame: Up to approximately 12 months ]
    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.

  4. First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator [ Time Frame: Up to approximately 72 months ]
    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.

  5. First Local Recurrence with Visceral Lesion or Distant Metastasis with Visceral Lesion or Secondary Systemic Malignancy with Visceral Lesion (DRSS2) as Assessed by the Investigator [ Time Frame: Up to approximately 72 months ]
    DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or distant metastasis with visceral lesion or secondary systemic malignancy with visceral lesion, whichever occurs first, as assessed by the investigator. For DRSS2, only disease recurrence with visceral lesion is counted as an event.

  6. DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator [ Time Frame: Up to approximately 72 months ]
    DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first.

  7. OS According to Participant PD-L1 Expression Status (Positive, Negative) [ Time Frame: Up to approximately 72 months ]
    OS is defined as the time from randomization to death due to any cause.

  8. Plasma Clearance (CL) of Pembrolizumab [ Time Frame: Cycles 1 and 2: Pre-dose and 0.5 hours (h) after end of infusion; Cycles 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months) ]
    CL is the volume of plasma from which a substance is completely removed per unit time.

  9. Volume of Distribution (VD) of Pembrolizumab [ Time Frame: Cycles 1 and 2: Pre-dose and 0.5 h after end of infusion; Cycles 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months) ]
    The VD of a drug represents the degree to which a drug is distributed in body tissue rather than the plasma. VD is directly correlated with the amount of drug distributed into tissue; a higher VD indicates a greater amount of tissue distribution.

  10. Development of Anti-pembrolizumab Antibodies [ Time Frame: Cycles 1, 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months) ]
    The number of participants who develop serum anti-pembrolizumab antibodies will be presented.

  11. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score [ Time Frame: 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) ]
    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.

  12. Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score [ Time Frame: 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142334


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Arizona Oncology Associates, PC- HAL ( Site 8018)
Phoenix, Arizona, United States, 85016
United States, California
USC Norris Comprehensive Cancer Center ( Site 0038)
Los Angeles, California, United States, 90033
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
San Francisco, California, United States, 94158
Sansum Clinic Research ( Site 8014)
Santa Barbara, California, United States, 93105
Stanford Cancer Center ( Site 0028)
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Cancer Center ( Site 8010)
Aurora, Colorado, United States, 80012
United States, District of Columbia
Georgetown University Medical Center ( Site 0002)
Washington, District of Columbia, United States, 20007
United States, Florida
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
Boca Raton, Florida, United States, 33486
Manatee Medical Research Institute ( Site 0039)
Bradenton, Florida, United States, 34205
Woodlands Medical Specialists, PA ( Site 8021)
Pensacola, Florida, United States, 32503
United States, Georgia
Northwest Georgia Oncology Centers PC ( Site 0014)
Marietta, Georgia, United States, 30060
United States, Illinois
Illinois Cancer Specialists ( Site 8001)
Niles, Illinois, United States, 60714
United States, Iowa
McFarland Clinic ( Site 0025)
Ames, Iowa, United States, 50010-3014
University of Iowa Hospital and Clinics ( Site 0031)
Iowa City, Iowa, United States, 52242
United States, Louisiana
University Medical Center New Orleans ( Site 0053)
New Orleans, Louisiana, United States, 70112
United States, Maryland
Weinberg Cancer Institute at Franklin Square ( Site 0046)
Baltimore, Maryland, United States, 21237
Maryland Oncology Hematology, P.A. ( Site 8020)
Rockville, Maryland, United States, 20850
United States, Massachusetts
Beth Israel Deaconess Medical Ctr. ( Site 0044)
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute (Boston) ( Site 0007)
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan ( Site 0045)
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute ( Site 0013)
Detroit, Michigan, United States, 48201
Henry Ford Hospital ( Site 0032)
Detroit, Michigan, United States, 48202
Quest Research Institute ( Site 0036)
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Fairview Southdale Medical Oncology Clinic ( Site 0041)
Edina, Minnesota, United States, 55435
Minnesota Oncology Specialist, PA ( Site 8002)
Minneapolis, Minnesota, United States, 55404
Park Nicollet Frauenshuh Cancer Center ( Site 0020)
Saint Louis Park, Minnesota, United States, 55426
United States, Montana
St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
Billings, Montana, United States, 59102
United States, Nebraska
Nebraska Cancer Specialists ( Site 0012)
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada ( Site 8013)
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0059)
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Cancer Center ( Site 0043)
Albuquerque, New Mexico, United States, 87106
United States, New York
Montefiore Medical Center ( Site 0009)
Bronx, New York, United States, 10461
United States, North Carolina
Duke University ( Site 0037)
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care, Inc. ( Site 8008)
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Northwest Cancer Specialists, P.C. ( Site 8006)
Tigard, Oregon, United States, 97223
United States, Pennsylvania
St. Luke's University Health Network ( Site 0042)
Easton, Pennsylvania, United States, 18045
Abramson Cancer Center ( Site 0010)
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Charleston Hematology Oncology Associates PA ( Site 8000)
Charleston, South Carolina, United States, 29414
Medical University of South Carolina ( Site 0033)
Charleston, South Carolina, United States, 29425
United States, South Dakota
Avera Cancer Institute ( Site 0023)
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Urology Associates [Nashville, TN] ( Site 0063)
Nashville, Tennessee, United States, 37209
United States, Texas
Texas Oncology-Austin Central ( Site 8003)
Austin, Texas, United States, 78731
Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
Dallas, Texas, United States, 75246
UT Southwestern Medical Center ( Site 0003)
Dallas, Texas, United States, 75390
Texas Oncology-Denton South ( Site 8016)
Denton, Texas, United States, 76210
Texas Oncology-Memorial City ( Site 8015)
Houston, Texas, United States, 77024
MD Anderson Cancer Center ( Site 0065)
Houston, Texas, United States, 77030
UTHealth/Memorial Hermann Cancer Center ( Site 0001)
Houston, Texas, United States, 77030
Texas Oncology- Paris ( Site 8004)
Paris, Texas, United States, 75460-5004
CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
San Antonio, Texas, United States, 78229
Texas Oncology-Tyler ( Site 8005)
Tyler, Texas, United States, 75702
Texas Oncology-Waco ( Site 8012)
Waco, Texas, United States, 76712
United States, Utah
IHO Corporation- Utah Cancer Specialists ( Site 0055)
Salt Lake City, Utah, United States, 84106
United States, Virginia
Virginia Oncology Associates ( Site 8011)
Norfolk, Virginia, United States, 23502
United States, Washington
Providence Regional Cancer Partnership ( Site 0016)
Everett, Washington, United States, 98201
SCCA/UW ( Site 0029)
Seattle, Washington, United States, 98109
Cancer Care Northwest ( Site 0021)
Spokane, Washington, United States, 99202
Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
Spokane, Washington, United States, 99208
Northwest Medical Specialties, PLLC ( Site 0034)
Tacoma, Washington, United States, 98405
Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
Yakima, Washington, United States, 98902
United States, Wisconsin
University of Wisconsin Carbone Cancer Center ( Site 0019)
Madison, Wisconsin, United States, 53792
Argentina
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
Viedma, Rio Negro, Argentina, R8500ACE
Sanatorio Parque ( Site 1104)
Rosario, Santa Fe, Argentina, S2000DSV
Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
Buenos Aires, Argentina, C1012AAR
Fundacion Favaloro ( Site 1110)
Buenos Aires, Argentina, C1093AAS
Instituto Medico Alexander Fleming ( Site 1105)
Buenos Aires, Argentina, C1426ANZ
Centro Oncologico Riojano Integral ( Site 1101)
La Rioja, Argentina, F5300COE
Centro Oncologico de Integracion Regional. COIR ( Site 1109)
Mendoza, Argentina, M5500AYB
Sanatorio Britanico ( Site 1106)
Rosario, Argentina, S2000CVB
Instituto de Oncologia de Rosario ( Site 1100)
Rosario, Argentina, S2000KZE
Centro Medico San Roque ( Site 1108)
Tucuman, Argentina, T4000IAK
Australia, New South Wales
Saint George Hospital [Kogarah, Australia] ( Site 0707)
Kogarah, New South Wales, Australia, 2217
Macquarie University Hospital ( Site 0700)
Macquarie Park, New South Wales, Australia, 2109
Australia, South Australia
Adelaide Cancer Centre ( Site 0703)
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Bendigo Cancer Centre ( Site 0704)
Bendigo, Victoria, Australia, 3550
Box Hill Hospital ( Site 0701)
Box Hill, Victoria, Australia, 3128
Australia, Western Australia
Fiona Stanley Hospital ( Site 0702)
Murdoch, Western Australia, Australia, 6150
Australia
Ballarat Health Services ( Site 0705)
Ballarat, Australia, 3350
Brazil
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
Curitiba, PR, Brazil, 80510-130
Liga Norte Riograndense Contra o Cancer ( Site 1013)
Natal, Rio Grande Do Norte, Brazil, 59075-740
Universidade de Caxias do Sul ( Site 1004)
Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
Hospital Bruno Born ( Site 1015)
Lajeado, RS, Brazil, 95900-000
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao ( Site 1000)
Porto Alegre, RS, Brazil, 91350-200
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
Barretos, Sao Paulo, Brazil, 14784-400
Fundacao Dr Amaral Carvalho ( Site 1005)
Jau, Sao Paulo, Brazil, 17210-120
Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
Sao Paulo, SP, Brazil, 01246-000
Casa de Saude Santa Marcelina ( Site 1006)
Sao Paulo, SP, Brazil, 08270-120
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
Ribeirao Preto, Brazil, 14048-900
COT Centro Oncologico do Triangulo Ltda ( Site 1014)
Uberlandia, Brazil, 38408-150
Canada, Manitoba
CancerCare Manitoba ( Site 0119)
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Dr. Leon Richard Oncology Centre ( Site 0106)
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
William Osler Health System ( Site 0115)
Brampton, Ontario, Canada, L6R 3J7
Juravinski Cancer Centre ( Site 0117)
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program - London HSC ( Site 0107)
London, Ontario, Canada, N6A 4L6
Lakeridge Health ( Site 0108)
Oshawa, Ontario, Canada, L1G 2B9
Niagara Health System - St. Catharines ( Site 0120)
St. Catharines, Ontario, Canada, L2S 0A9
Canada, Quebec
CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
Chicoutimi, Quebec, Canada, G7H 5H6
CISSS-CA Hotel Dieu de Levis ( Site 0111)
Lévis, Quebec, Canada, G6V 3Z1
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
Montreal, Quebec, Canada, H1T 2M4
St-Jerome Medical Research Inc ( Site 0103)
St-Jerome, Quebec, Canada, J7Z 5T3
Canada, Saskatchewan
Allan Blair Cancer Centre ( Site 0116)
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre ( Site 0105)
Saskatoon, Saskatchewan, Canada, S7N 4H4
Chile
Instituto Nacional del Cancer ( Site 0912)
Santiago, Region Metropolitana, Chile, 8380455
Centro Oncologico Antofagasta ( Site 0914)
Antofagasta, Chile, 1240000
Hospital Regional de La Serena ( Site 0907)
La Serena, Chile, 1710216
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
Rancagua, Chile, 2820000
Health and Care Chile ( Site 0901)
Santiago, Chile, 7500006
Fundacion Arturo Lopez Perez FALP ( Site 0902)
Santiago, Chile, 7500921
Iram Cancer Research ( Site 0909)
Santiago, Chile, 7630372
Hospital Militar de Santiago ( Site 0911)
Santiago, Chile, 7850000
Pontificia Universidad Catolica de Chile ( Site 0904)
Santiago, Chile, 8330032
Hospital Clinico Universidad de Chile ( Site 0905)
Santiago, Chile, 8380456
Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
Temuco, Chile, 4810469
Oncocentro ( Site 0900)
Vina del Mar, Chile, 2520598
Colombia
Hospital Pablo Tobon Uribe. ( Site 0805)
Medellin, Antioquia, Colombia, 050034
Clinica de la Costa Ltda. ( Site 0804)
Barranquilla, Atlantico, Colombia, 080020
Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
Valledupar, Cesar, Colombia, 200001
Instituto Nacional de Cancerologia E.S.E ( Site 0807)
Bogota, Cundinamarca, Colombia, 111161
Oncologos del Occidente S.A. ( Site 0800)
Pereira, Risaralda, Colombia, 661002
Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
Bogota, Colombia, 110131
Administradora Country SA - Clinica del Country ( Site 0808)
Bogota, Colombia, 110221
Oncomedica S.A. ( Site 0801)
Monteria, Colombia, 230002
Czechia
FN Brno. ( Site 1501)
Brno, Czechia, 625 00
Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
Novy Jicin, Czechia, 741 01
Fakultni nemocnice Olomouc ( Site 1502)
Olomouc, Czechia, 775 20
Fakultni nemocnice Ostrava ( Site 1507)
Ostrava, Czechia, 708 52
Thomayerova nemocnice ( Site 1505)
Praha 4, Czechia, 140 59
Fakultni nemocnice v Motole ( Site 1504)
Praha 5, Czechia, 150 06
Nemocnice Na Bulovce ( Site 1503)
Praha 8, Czechia, 180 81
Finland
HYKS ( Site 2300)
Helsinki, Finland, 00290
Keski-Suomen keskussairaala ( Site 2303)
Jyvaskyla, Finland, 40620
Oulun yliopistollinen sairaala - OYS ( Site 2304)
Oulu, Finland, 90220
TAYS ( Site 2301)
Tampere, Finland, 33520
TYKS ( Site 2302)
Turku, Finland, 20521
France
ICO Centre Paul Papin ( Site 2208)
Angers, France, 49055
CHU Besancon - Hopital Jean Minjoz ( Site 2200)
Besancon, France, 25000
Hopital Saint Andre ( Site 2202)
Bordeaux, France, 33075
Hopital La Timone ( Site 2204)
Marseille, France, 13005
CHU Saint-Eloi ( Site 2203)
Montpellier, France, 34295
Centre Antoine Lacassagne ( Site 2211)
Nice, France, 06189
Hopital Europeen Georges Pompidou ( Site 2206)
Paris, France, 75908
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
Pierre Benite, France, 69310
Centre Eugene Marquis ( Site 2209)
Rennes, France, 35042
Centre Rene Gauducheau ICO ( Site 2207)
Saint Herblain, France, 44805
Institut Claudius Regaud IUCT Oncopole ( Site 2201)
Toulouse, France, 31059
Germany
Campus Charite Mitte ( Site 2120)
Berlin, Germany, 10117
Helios Klinikum Berlin Buch ( Site 2125)
Berlin, Germany, 13125
Universitaetsklinikum Bonn ( Site 2110)
Bonn, Germany, 53127
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
Dresden, Germany, 01307
Universitatsklinikum Dusseldorf ( Site 2108)
Dusseldorf, Germany, 40225
Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
Erlangen, Germany, 91054
Universitaetsklinikum Essen ( Site 2116)
Essen, Germany, 45122
Universitaetsklinikum Frankfurt ( Site 2121)
Frankfurt, Germany, 60590
Universitaetsklinikum Freiburg ( Site 2119)
Freiburg, Germany, 79106
Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
Hamburg, Germany, 20246
Universitaetsklinikum Jena. ( Site 2104)
Jena, Germany, 07747
Universitaetsklinikum Schleswig Holstein ( Site 2109)
Luebeck, Germany, 23538
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
Mainz, Germany, 55131
Studienpraxis Urologie ( Site 2115)
Nuertingen, Germany, 72622
Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
Trier, Germany, 54292
Universitaetsklinikum Tuebingen ( Site 2100)
Tuebingen, Germany, 72076
Ireland
Beaumont Hospital ( Site 1611)
Dublin, Ireland, D04 Y8V0
St Vincents University Hospital ( Site 1610)
Dublin, Ireland, D04 Y8V0
University Hospital Waterford ( Site 1614)
Waterford, Ireland, X91 ER8E
Italy
Ospedale San Luigi Gonzaga ( Site 2010)
Orbassano, Torino, Italy, 10043
Medical Oncology Ospedale San Donato ( Site 2004)
Arezzo, Italy, 52100
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
Meldola, Italy, 47014
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
Milano, Italy, 20133
Istituto Europeo di Oncologia ( Site 2000)
Milano, Italy, 20141
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
Modena, Italy, 41125
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
Napoli, Italy, 80131
Istituto Nazionale Tumori Regina Elena ( Site 2009)
Roma, Italy, 00144
Japan
Nagoya University Hospital ( Site 0431)
Nagoya, Aichi, Japan, 466-8560
Sapporo Medical University Hospital ( Site 0424)
Sapporo, Hokkaido, Japan, 060-8543
Kagawa University Hospital ( Site 0419)
Kita-gun, Kagawa, Japan, 761-0793
Japan Community Health care Organization Sendai Hospital ( Site 0430)
Sendai, Miyagi, Japan, 981-8501
Nara Medical University Hospital ( Site 0416)
Kashihara, Nara, Japan, 634-8522
Kindai University Hospital ( Site 0411)
Osakasayama, Osaka, Japan, 589-8511
Osaka Rosai Hospital ( Site 0418)
Sakai, Osaka, Japan, 591-8025
Saitama Medical University International Medical Center ( Site 0404)
Hidaka, Saitama, Japan, 350-1298
Yamaguchi University Hospital ( Site 0406)
Ube, Yamaguchi, Japan, 755-8505
Akita University Hospital ( Site 0433)
Akita, Japan, 010-8543
Harasanshin Hospital ( Site 0402)
Fukuoka, Japan, 812-0033
Kyushu University Hospital ( Site 0413)
Fukuoka, Japan, 812-8582
Kumamoto University Hospital ( Site 0434)
Kumamoto, Japan, 860-8556
Nagano Municipal Hospital ( Site 0429)
Nagano, Japan, 381-8551
Niigata University Medical & Dental Hospital ( Site 0421)
Niigata, Japan, 951-8520
Osaka International Cancer Institute ( Site 0401)
Osaka, Japan, 541-8567
Osaka City University Hospital ( Site 0428)
Osaka, Japan, 545-8586
Toranomon Hospital ( Site 0426)
Tokyo, Japan, 105-8470
Nippon Medical School Hospital ( Site 0400)
Tokyo, Japan, 113-8603
Keio University Hospital ( Site 0407)
Tokyo, Japan, 160-8582
Toyama University Hospital ( Site 0432)
Toyama, Japan, 930-0194
Korea, Republic of
National Cancer Center ( Site 0304)
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Hospital ( Site 0302)
Seoul, Korea, Republic of, 03080
Severance Hospital Yonsei University Health System ( Site 0303)
Seoul, Korea, Republic of, 03722
Asan Medical Center ( Site 0300)
Seoul, Korea, Republic of, 05505
Samsung Medical Center ( Site 0301)
Seoul, Korea, Republic of, 06351
Netherlands
Amphia Ziekenhuis Breda ( Site 1901)
Breda, Netherlands, 4819 EV
Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
Maastricht, Netherlands, 6229 HX
Franciscus Gasthuis ( Site 1903)
Rotterdam, Netherlands, 3045 PM
Poland
Mazowiecki Szpital Onkologiczny ( Site 1316)
Wieliszew, Mazowieckie, Poland, 05-135
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
Koscierzyna, Pomorskie, Poland, 83-400
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
Brzozow, Poland, 36-200
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
Bytom, Poland, 41-902
Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
Gdansk, Poland, 80-219
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
Gdynia, Poland, 81-519
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
Gliwice, Poland, 44-101
Przychodnia Lekarska Komed ( Site 1306)
Konin, Poland, 62-500
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
Krakow, Poland, 31-115
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
Lublin, Poland, 20-090
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
Otwock, Poland, 05-400
Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
Poznan, Poland, 60-569
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
Torun, Poland, 87-100
Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
Warszawa, Poland, 02-793
Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
Warszawa, Poland, 04-141
Russian Federation
Ivanovo Regional Oncology Dispensary ( Site 1204)
Ivanovo, Russian Federation, 153040
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
Krasnoyarsk, Russian Federation, 660133
N.N. Blokhin NMRCO ( Site 1206)
Moscow, Russian Federation, 115478
Russian Scientific Center of Roentgenoradiology ( Site 1201)
Moscow, Russian Federation, 117997
National Medical Research Radiology Centre ( Site 1200)
Moscow, Russian Federation, 125284
Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
Murmansk, Russian Federation, 183057
Omsk Clinical Oncology Dispensary ( Site 1209)
Omsk, Russian Federation, 644013
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
Saint Petersburg, Russian Federation, 197758
Tomsk Scientific Research Institute of Oncology ( Site 1208)
Tomsk, Russian Federation, 634028
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
Ufa, Russian Federation, 450054
Clinical Hospital Bashkirsky Medical State University ( Site 1202)
Ufa, Russian Federation, 450083
Spain
Hospital Universitario Infanta Cristina ( Site 1805)
Badajoz, Spain, 06080
Hospital de la Santa Creu i Sant Pau ( Site 1807)
Barcelona, Spain, 08026
Hospital de Girona Dr. Josep Trueta ( Site 1806)
Girona, Spain, 17007
Hospital Universitario Gregorio Maranon ( Site 1801)
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal ( Site 1800)
Madrid, Spain, 28034
Hospital Universitario Virgen de la Victoria ( Site 1808)
Malaga, Spain, 29010
Clinica Universitaria de Navarra ( Site 1803)
Pamplona, Spain, 31008
Instituto Valenciano de Oncologia ( Site 1804)
Valencia, Spain, 46009
Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
Valencia, Spain, 46026
Taiwan
China Medical University Hospital ( Site 0200)
Taichung, Taiwan, 40447
Taichung Veterans General Hospital ( Site 0204)
Taichung, Taiwan, 407
National Taiwan University Hospital ( Site 0202)
Taipei, Taiwan, 10002
Taipei Veterans General Hospital ( Site 0201)
Taipei, Taiwan, 112
Chang Gung Medical Foundation. Linkou ( Site 0203)
Taoyuan, Taiwan, 333
United Kingdom
North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
Stoke-On-Trent, Staffordshire, United Kingdom, ST4 6QG
Western General Hospital ( Site 1600)
Edinburgh, United Kingdom, EH4 2XU
The Beatson West of Scotland Cancer Centre ( Site 1605)
Glasgow, United Kingdom, G12 0YN
Royal Free Hospital ( Site 1609)
London, United Kingdom, NW3 2QG
St George s Healthcare Trust ( Site 1608)
London, United Kingdom, SW17 0QT
Charing Cross Hospital ( Site 1607)
London, United Kingdom, W6 8RF
The Christie NHS Foundation Trust ( Site 1602)
Manchester, United Kingdom, M20 4BX
The James Cook University Hospital ( Site 1606)
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03142334     History of Changes
Other Study ID Numbers: 3475-564
2016-004351-75 ( EudraCT Number )
173704 ( Registry Identifier: JAPAC-CTI )
MK-3475-564 ( Other Identifier: Merck Protocol Number )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PDL1
PD-L1
Adjuvant

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents