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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03142334
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : May 23, 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.

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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


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

  Hide Study Locations
Locations
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United States, Arizona
Arizona Oncology Associates, PC- HAL ( Site 8018) Completed
Phoenix, Arizona, United States, 85016
United States, California
USC Norris Comprehensive Cancer Center ( Site 0038) Recruiting
Los Angeles, California, United States, 90033
Contact: Study Coordinator    323-865-3956      
Sansum Clinic Research ( Site 8014) Recruiting
Santa Barbara, California, United States, 93105
Contact: Study Coordinator    713-245-0474      
Stanford Cancer Center ( Site 0028) Recruiting
Stanford, California, United States, 94305
Contact: Study Coordinator    650-736-1640      
United States, Colorado
Rocky Mountain Cancer Center ( Site 8010) Recruiting
Aurora, Colorado, United States, 80012
Contact: Study Coordinator    713-245-0474      
United States, District of Columbia
Georgetown University Medical Center ( Site 0002) Recruiting
Washington, District of Columbia, United States, 20007
Contact: Study Coordinator    202-687-1116      
United States, Florida
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035) Recruiting
Boca Raton, Florida, United States, 33486
Contact: Study Coordinator    561-955-5630      
Manatee Medical Research Institute ( Site 0039) Recruiting
Bradenton, Florida, United States, 34205
Contact: Study Coordinator    941-792-0340      
Woodlands Medical Specialists, PA ( Site 8021) Recruiting
Pensacola, Florida, United States, 32503
Contact: Study Coordinator    713-245-0474      
United States, Georgia
Northwest Georgia Oncology Centers PC ( Site 0014) Recruiting
Marietta, Georgia, United States, 30060
Contact: Study Coordinator    770-281-5156      
United States, Illinois
Illinois Cancer Specialists ( Site 8001) Completed
Niles, Illinois, United States, 60714
United States, Iowa
McFarland Clinic ( Site 0025) Recruiting
Ames, Iowa, United States, 50010-3014
Contact: Study Coordinator    515-956-4159      
University of Iowa Hospital and Clinics ( Site 0031) Recruiting
Iowa City, Iowa, United States, 52242
Contact: Study Coordinator    319-356-4568      
United States, Louisiana
University Medical Center New Orleans ( Site 0053) Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Study Coordinator    504-702-3149      
United States, Maryland
Weinberg Cancer Institute at Franklin Square ( Site 0046) Recruiting
Baltimore, Maryland, United States, 21237
Contact: Study Coordinator    443-777-7364      
Maryland Oncology Hematology, P.A. ( Site 8020) Recruiting
Rockville, Maryland, United States, 20850
Contact: Study Coordinator    713-245-0474      
United States, Massachusetts
Beth Israel Deaconess Medical Ctr. ( Site 0044) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Study Coordinator    617-632-9245      
Dana-Farber Cancer Institute (Boston) ( Site 0007) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Study Coordinator    617-632-5261      
United States, Michigan
University of Michigan ( Site 0045) Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Study Coordinator    734-232-0753      
Karmanos Cancer Institute ( Site 0013) Recruiting
Detroit, Michigan, United States, 48201
Contact: Study Coordinator    313-576-9703      
Henry Ford Hospital ( Site 0032) Recruiting
Detroit, Michigan, United States, 48202
Contact: Study Coordinator    313-916-1784      
Quest Research Institute ( Site 0036) Completed
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Fairview Southdale Medical Oncology Clinic ( Site 0041) Recruiting
Edina, Minnesota, United States, 55435
Contact: Study Coordinator    612-672-5233      
Minnesota Oncology Specialist, PA ( Site 8002) Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Study Coordinator    713-245-0474      
Park Nicollet Frauenshuh Cancer Center ( Site 0020) Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Study Coordinator    952-993-6705      
United States, Montana
St. Vincent Healthcare Frontier Cancer Center ( Site 0008) Recruiting
Billings, Montana, United States, 59102
Contact: Study Coordinator    406-238-6290      
United States, Nebraska
Nebraska Cancer Specialists ( Site 0012) Recruiting
Omaha, Nebraska, United States, 68130
Contact: Study Coordinator    402-334-4773      
United States, Nevada
Comprehensive Cancer Centers of Nevada ( Site 8013) Completed
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0059) Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Study Coordinator    732-235-6048      
United States, New Mexico
University of New Mexico Cancer Center ( Site 0043) Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Study Coordinator    505-925-0478      
United States, New York
Montefiore Medical Center ( Site 0009) Completed
Bronx, New York, United States, 10461
United States, North Carolina
Duke University ( Site 0037) Recruiting
Durham, North Carolina, United States, 27710
Contact: Study Coordinator    919-681-9822      
United States, Ohio
Oncology Hematology Care, Inc. ( Site 8008) Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Study Coordinator    713-245-0474      
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052) Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Study Coordinator    918-505-3200      
United States, Oregon
Northwest Cancer Specialists, P.C. ( Site 8006) Recruiting
Tigard, Oregon, United States, 97223
Contact: Study Coordinator    713-245-0474      
United States, Pennsylvania
St. Luke's University Health Network ( Site 0042) Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Study Coordinator    484-503-4157      
Abramson Cancer Center ( Site 0010) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Study Coordinator    215-662-7383      
United States, South Carolina
Charleston Hematology Oncology Associates PA ( Site 8000) Recruiting
Charleston, South Carolina, United States, 29414
Contact: Study Coordinator    713-254-0474      
Medical University of South Carolina ( Site 0033) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Study Coordinator    843-792-2306      
United States, South Dakota
Avera Cancer Institute ( Site 0023) Completed
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Urology Associates [Nashville, TN] ( Site 0063) Recruiting
Nashville, Tennessee, United States, 37209
Contact: Study Coordinator    615-250-9240      
United States, Texas
Texas Oncology-Austin Central ( Site 8003) Recruiting
Austin, Texas, United States, 78731
Contact: Study Coordinator    713-254-0474      
Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019) Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator    713-245-0474      
UT Southwestern Medical Center ( Site 0003) Recruiting
Dallas, Texas, United States, 75390
Contact: Study Coordinator    410-502-4658      
Texas Oncology-Denton South ( Site 8016) Completed
Denton, Texas, United States, 76210
Texas Oncology-Memorial City ( Site 8015) Recruiting
Houston, Texas, United States, 77024
Contact: Study Coordinator    713-245-0474      
UTHealth/Memorial Hermann Cancer Center ( Site 0001) Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    832-325-7702      
Texas Oncology- Paris ( Site 8004) Completed
Paris, Texas, United States, 75460-5004
CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026) Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-450-5798      
Texas Oncology-Tyler ( Site 8005) Recruiting
Tyler, Texas, United States, 75702
Contact: Study Coordinator    713-245-0474      
Texas Oncology-Waco ( Site 8012) Completed
Waco, Texas, United States, 76712
United States, Utah
IHO Corporation- Utah Cancer Specialists ( Site 0055) Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Study Coordinator    801-281-6864      
United States, Virginia
Virginia Oncology Associates ( Site 8011) Recruiting
Norfolk, Virginia, United States, 23502
Contact: Study Coordinator    713-245-0474      
United States, Washington
Providence Regional Cancer Partnership ( Site 0016) Recruiting
Everett, Washington, United States, 98201
Contact: Study Coordinator    425-261-3544      
SCCA/UW ( Site 0029) Recruiting
Seattle, Washington, United States, 98109
Contact: Study Coordinator    206-288-7476      
Cancer Care Northwest ( Site 0021) Recruiting
Spokane, Washington, United States, 99202
Contact: Study Coordinator    509-228-1687      
Medical Oncology Associates (Summit Cancer Centers) ( Site 0005) Completed
Spokane, Washington, United States, 99208
Northwest Medical Specialties, PLLC ( Site 0034) Recruiting
Tacoma, Washington, United States, 98405
Contact: Study Coordinator    253-428-8725      
Yakima Valley Memorial Hospital North Star Lodge ( Site 8017) Completed
Yakima, Washington, United States, 98902
United States, Wisconsin
University of Wisconsin Carbone Cancer Center ( Site 0019) Completed
Madison, Wisconsin, United States, 53792
Argentina
Sanatorio Parque ( Site 1104) Recruiting
Rosario, Santa Fe, Argentina, S2000DSV
Contact: Study Coordinator    +5493416149812      
Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113) Recruiting
Buenos Aires, Argentina, C1012AAR
Contact: Study Coordinator    541150314164      
Fundacion Favaloro ( Site 1110) Recruiting
Buenos Aires, Argentina, C1093AAS
Contact: Study Coordinator    +541143043202      
Instituto Medico Alexander Fleming ( Site 1105) Recruiting
Buenos Aires, Argentina, C1426ANZ
Contact: Study Coordinator    +541132218900      
Centro Oncologico Riojano Integral ( Site 1101) Recruiting
La Rioja, Argentina, F5300COE
Contact: Study Coordinator    +54380154271207      
Centro Oncologico de Integracion Regional. COIR ( Site 1109) Recruiting
Mendoza, Argentina, M5500AYB
Contact: Study Coordinator    +5492615736010      
Sanatorio Britanico ( Site 1106) Recruiting
Rosario, Argentina, S2000CVB
Contact: Study Coordinator    +543414205500      
Instituto de Oncologia de Rosario ( Site 1100) Recruiting
Rosario, Argentina, S2000KZE
Contact: Study Coordinator    +543414218909      
Centro Medico San Roque ( Site 1108) Recruiting
Tucuman, Argentina, T4000IAK
Contact: Study Coordinator    +5493815186197      
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102) Recruiting
Viedma, Argentina, R8500ACE
Contact: Study Coordinator    +5492920601693      
Australia, New South Wales
Saint George Hospital [Kogarah, Australia] ( Site 0707) Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Study Coordinator    +61295539220      
Macquarie University Hospital ( Site 0700) Recruiting
Macquarie Park, New South Wales, Australia, 2109
Contact: Study Coordinator    +61298502766      
Australia, South Australia
Adelaide Cancer Centre ( Site 0703) Recruiting
Kurralta Park, South Australia, Australia, 5037
Contact: Study Coordinator    +61882922240      
Australia, Victoria
Bendigo Cancer Centre ( Site 0704) Recruiting
Bendigo, Victoria, Australia, 3550
Contact: Study Coordinator    +61354548815      
Box Hill Hospital ( Site 0701) Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Study Coordinator    +61398953281      
Australia
Ballarat Health Services ( Site 0705) Recruiting
Ballarat, Australia, 3350
Contact: Study Coordinator    +61353204735      
Fiona Stanley Hospital ( Site 0702) Recruiting
Perth, Australia, 6150
Contact: Study Coordinator    +61861526531      
Brazil
Liga Norte Riograndense Contra o Cancer ( Site 1013) Recruiting
Natal, Rio Grande Do Norte, Brazil, 59075-740
Contact: Study Coordinator    +558440095595      
Universidade de Caxias do Sul ( Site 1004) Recruiting
Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
Contact: Study Coordinator    +5511432182026      
Hospital Bruno Born ( Site 1015) Recruiting
Lajeado, RS, Brazil, 95900-000
Contact: Study Coordinator    +5551371475002476      
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001) Recruiting
Porto Alegre, RS, Brazil, 90610-000
Contact: Study Coordinator    +555199892554      
Hospital Nossa Senhora da Conceicao ( Site 1000) Recruiting
Porto Alegre, RS, Brazil, 91350-200
Contact: Study Coordinator    +5551991922412      
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002) Recruiting
Barretos, Sao Paulo, Brazil, 14784-400
Contact: Study Coordinator    +551733216638      
Fundacao Dr Amaral Carvalho ( Site 1005) Recruiting
Jau, Sao Paulo, Brazil, 17210-120
Contact: Study Coordinator    +551436249422      
Instituto do Cancer de Sao Paulo - ICESP ( Site 1010) Recruiting
Sao Paulo, SP, Brazil, 01246-000
Contact: Study Coordinator    +551138932528      
Casa de Saude Santa Marcelina ( Site 1006) Recruiting
Sao Paulo, SP, Brazil, 08270-120
Contact: Study Coordinator    +551122173766      
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012) Recruiting
Curitiba, Brazil, 80510-130
Contact: Study Coordinator    +5541999864616      
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016) Recruiting
Ribeirao Preto, Brazil, 14048-900
Contact: Study Coordinator    +551636022482      
COT Centro Oncologico do Triangulo Ltda ( Site 1014) Recruiting
Uberlandia, Brazil, 38408-150
Contact: Study Coordinator    +553432913519      
Canada, Manitoba
CancerCare Manitoba ( Site 0119) Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Study Coordinator    2047874156      
Canada, New Brunswick
Dr. Leon Richard Oncology Centre ( Site 0106) Completed
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
William Osler Health System ( Site 0115) Completed
Brampton, Ontario, Canada, L6R 3J7
Juravinski Cancer Centre ( Site 0117) Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Study Coordinator    905387949563123      
London Regional Cancer Program - London HSC ( Site 0107) Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Study Coordinator    5196858640      
Lakeridge Health ( Site 0108) Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Study Coordinator    9055768711      
Niagara Health System - St. Catharines ( Site 0120) Recruiting
St. Catharines, Ontario, Canada, L2S 0A9
Contact: Study Coordinator    905684727143801      
Canada, Quebec
CIUSSS du Saguenay-Lac-St-Jean ( Site 0113) Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
Contact: Study Coordinator    4185411000      
CISSS-CA Hotel Dieu de Levis ( Site 0111) Recruiting
Lévis, Quebec, Canada, G6V 3Z1
Contact: Study Coordinator    4188357121      
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118) Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Study Coordinator    51425234005823      
St-Jerome Medical Research Inc ( Site 0103) Recruiting
St-Jerome, Quebec, Canada, J7Z 5T3
Contact: Study Coordinator    450431102042      
Canada, Saskatchewan
Allan Blair Cancer Centre ( Site 0116) Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Study Coordinator    3067662213      
Saskatoon Cancer Centre ( Site 0105) Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Study Coordinator    3066552640      
Chile
Instituto Nacional del Cancer ( Site 0912) Recruiting
Santiago, Region Metropolitana, Chile, 8380455
Contact: Study Coordinator    +56984298842      
Centro Oncologico Antofagasta ( Site 0914) Recruiting
Antofagasta, Chile, 1240000
Contact: Study Coordinator    +56994198125      
Hospital Regional de La Serena ( Site 0907) Completed
La Serena, Chile, 1710216
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910) Completed
Rancagua, Chile, 2820000
Health and Care Chile ( Site 0901) Recruiting
Santiago, Chile, 7500006
Contact: Study Coordinator    +56992214787      
Fundacion Arturo Lopez Perez FALP ( Site 0902) Recruiting
Santiago, Chile, 7500921
Contact: Study Coordinator    +56224457254      
Iram Cancer Research ( Site 0909) Recruiting
Santiago, Chile, 7630372
Contact: Study Coordinator    +569944332241      
Hospital Militar de Santiago ( Site 0911) Completed
Santiago, Chile, 7850000
Pontificia Universidad Catolica de Chile ( Site 0904) Recruiting
Santiago, Chile, 8330032
Contact: Study Coordinator    +56942477513      
Hospital Clinico Universidad de Chile ( Site 0905) Recruiting
Santiago, Chile, 8380456
Contact: Study Coordinator    +56998865341      
Sociedad de Investigaciones Medicas Limitadas ( Site 0913) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56974316500      
Oncocentro ( Site 0900) Recruiting
Vina del Mar, Chile, 2520598
Contact: Study Coordinator    +56992369820      
Colombia
Hospital Pablo Tobon Uribe. ( Site 0805) Recruiting
Medellin, Antioquia, Colombia, 050034
Contact: Study Coordinator    5744459753      
Clinica de la Costa Ltda. ( Site 0804) Recruiting
Barranquilla, Atlantico, Colombia, 080020
Contact: Study Coordinator    +5753369940      
Sociedad de Hematologia y Oncologia del Cesar ( Site 0809) Recruiting
Valledupar, Cesar, Colombia, 200001
Contact: Study Coordinator    +5755602310      
Instituto Nacional de Cancerologia E.S.E ( Site 0807) Recruiting
Bogota, Cundinamarca, Colombia, 111161
Contact: Study Coordinator    +5714320160      
Oncologos del Occidente S.A. ( Site 0800) Recruiting
Pereira, Risaralda, Colombia, 661002
Contact: Study Coordinator    +5763310712      
Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803) Completed
Bogota, Colombia, 110131
Oncomedica S.A. ( Site 0801) Recruiting
Monteria, Colombia, 230002
Contact: Study Coordinator    +573135342052      
Czechia
FN Brno. ( Site 1501) Recruiting
Brno, Czechia, 625 00
Contact: Study Coordinator    +420532233642      
Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506) Recruiting
Novy Jicin, Czechia, 741 01
Contact: Study Coordinator    +420724360436      
Fakultni nemocnice Olomouc ( Site 1502) Recruiting
Olomouc, Czechia, 775 20
Contact: Study Coordinator    +420588444295      
Fakultni nemocnice Ostrava ( Site 1507) Recruiting
Ostrava, Czechia, 708 52
Contact: Study Coordinator    +420721782888      
Thomayerova nemocnice ( Site 1505) Recruiting
Praha 4, Czechia, 140 59
Contact: Study Coordinator    +420261083530      
Fakultni nemocnice v Motole ( Site 1504) Completed
Praha 5, Czechia, 150 06
Nemocnice Na Bulovce ( Site 1503) Recruiting
Praha 8, Czechia, 180 81
Contact: Study Coordinator    +420266084516      
Finland
HYKS ( Site 2300) Recruiting
Helsinki, Finland, 00290
Contact: Study Coordinator    +358504270943      
Keski-Suomen keskussairaala ( Site 2303) Recruiting
Jyvaskyla, Finland, 40620
Contact: Study Coordinator    +358142693586      
Oulun yliopistollinen sairaala - OYS ( Site 2304) Recruiting
Oulu, Finland, 90220
Contact: Study Coordinator    +35883152870      
TAYS ( Site 2301) Recruiting
Tampere, Finland, 33520
Contact: Study Coordinator    +358331166535      
TYKS ( Site 2302) Recruiting
Turku, Finland, 20521
Contact: Study Coordinator    +35823135925      
France
ICO Centre Paul Papin ( Site 2208) Recruiting
Angers, France, 49055
Contact: Study Coordinator    +33241352734      
CHU Besancon - Hopital Jean Minjoz ( Site 2200) Recruiting
Besancon, France, 25030
Contact: Study Coordinator    +33142116264      
Hopital Saint Andre ( Site 2202) Recruiting
Bordeaux, France, 33000
Contact: Study Coordinator    +33556795708      
Hopital La Timone ( Site 2204) Recruiting
Marseille, France, 13005
Contact: Study Coordinator    +33491385708      
CHU Saint-Eloi ( Site 2203) Recruiting
Montpellier, France, 34295
Contact: Study Coordinator    +33467332309      
Centre Antoine Lacassagne ( Site 2211) Recruiting
Nice, France, 06189
Contact: Study Coordinator    +33492031514      
Hopital Europeen Georges Pompidou ( Site 2206) Recruiting
Paris, France, 75908
Contact: Study Coordinator    +33156095833      
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212) Recruiting
Pierre Benite, France, 69310
Contact: Study Coordinator    +33478864324      
Centre Eugene Marquis ( Site 2209) Recruiting
Rennes, France, 35042
Contact: Study Coordinator    +33299253182      
Centre Rene Gauducheau ICO ( Site 2207) Completed
Saint Herblain, France, 44805
Institut Claudius Regaud IUCT Oncopole ( Site 2201) Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33561424174      
Germany
Campus Charite Mitte ( Site 2120) Recruiting
Berlin, Germany, 10117
Contact: Study Coordinator    +4930450615206      
Helios Klinikum Berlin Buch ( Site 2125) Recruiting
Berlin, Germany, 13125
Contact: Study Coordinator    +4930940154801      
Universitaetsklinikum Bonn ( Site 2110) Recruiting
Bonn, Germany, 53127
Contact: Study Coordinator    +4922828714428      
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113) Recruiting
Dresden, Germany, 01307
Contact: Study Coordinator    +493514582442      
Universitatsklinikum Dusseldorf ( Site 2108) Completed
Dusseldorf, Germany, 40225
Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102) Recruiting
Erlangen, Germany, 91058
Contact: Study Coordinator    +4991318223178      
Universitaetsklinikum Essen ( Site 2116) Recruiting
Essen, Germany, 45122
Contact: Study Coordinator    +492017232896      
Universitaetsklinikum Frankfurt ( Site 2121) Recruiting
Frankfurt, Germany, 60590
Contact: Study Coordinator    +4969630186724      
Universitaetsklinikum Freiburg ( Site 2119) Recruiting
Freiburg, Germany, 79106
Contact: Study Coordinator    +4976127028920      
Universitaetsklinikum Hamburg-Eppendorf ( Site 2118) Recruiting
Hamburg, Germany, 20246
Contact: Study Coordinator    +4940741054779      
Universitaetsklinikum Jena. ( Site 2104) Recruiting
Jena, Germany, 07747
Contact: Study Coordinator    +491711421827      
Universitaetsklinikum Schleswig Holstein ( Site 2109) Recruiting
Luebeck, Germany, 23538
Contact: Study Coordinator    +494515002290      
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111) Recruiting
Mainz, Germany, 55131
Contact: Study Coordinator    +496131170      
Studienpraxis Urologie ( Site 2115) Recruiting
Nuertingen, Germany, 72622
Contact: Study Coordinator    +491703809223      
Krankenhaus der Barmherzigen Brueder Trier ( Site 2117) Recruiting
Trier, Germany, 54292
Contact: Study Coordinator    +496512081921      
Universitaetsklinikum Tuebingen ( Site 2100) Recruiting
Tuebingen, Germany, 72076
Contact: Study Coordinator    +4970712987235      
Ireland
Beaumont Hospital ( Site 1611) Recruiting
Dublin, Ireland, D04 Y8V0
Contact: Study Coordinator    +3534144259      
St Vincents University Hospital ( Site 1610) Recruiting
Dublin, Ireland, D04 Y8V0
Contact: Study Coordinator    +3534144259      
University Hospital Waterford ( Site 1614) Recruiting
Waterford, Ireland, X91 ER8E
Contact: Study Coordinator    +35351848934      
Italy
Ospedale San Luigi Gonzaga ( Site 2010) Recruiting
Orbassano, Torino, Italy, 10043
Contact: Study Coordinator    +390119026993      
Medical Oncology Ospedale San Donato ( Site 2004) Recruiting
Arezzo, Italy, 52100
Contact: Study Coordinator    +390575255439      
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012) Recruiting
Meldola, Italy, 47014
Contact: Study Coordinator    +393701279770      
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005) Recruiting
Milano, Italy, 20133
Contact: Study Coordinator    +393701279770      
Istituto Europeo di Oncologia ( Site 2000) Recruiting
Milano, Italy, 20141
Contact: Study Coordinator    +390257489460      
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006) Recruiting
Modena, Italy, 41125
Contact: Study Coordinator    +393701279770      
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903637      
Istituto Nazionale Tumori Regina Elena ( Site 2009) Recruiting
Roma, Italy, 00144
Contact: Study Coordinator    +390652666919      
Japan
Nagoya University Hospital ( Site 0431) Recruiting
Nagoya, Aichi, Japan, 466-8560
Contact: Study Coordinator    +81527412111      
Sapporo Medical University Hospital ( Site 0424) Recruiting
Sapporo, Hokkaido, Japan, 060-8543
Contact: Study Coordinator    +81116112111      
Kagawa University Hospital ( Site 0419) Recruiting
Kita-gun, Kagawa, Japan, 761-0793
Contact: Study Coordinator    +81878985111      
Japan Community Health care Organization Sendai Hospital ( Site 0430) Recruiting
Sendai, Miyagi, Japan, 981-8501
Contact: Study Coordinator    +81222753111      
Nara Medical University Hospital ( Site 0416) Recruiting
Kashihara, Nara, Japan, 634-8522
Contact: Study Coordinator    +81744223051      
Kindai University Hospital ( Site 0411) Recruiting
Osakasayama, Osaka, Japan, 589-8511
Contact: Study Coordinator    +81723660221      
Osaka Rosai Hospital ( Site 0418) Active, not recruiting
Sakai, Osaka, Japan, 591-8025
Saitama Medical University International Medical Center ( Site 0404) Recruiting
Hidaka, Saitama, Japan, 350-1298
Contact: Study Coordinator    +81429844111      
Yamaguchi University Hospital ( Site 0406) Recruiting
Ube, Yamaguchi, Japan, 755-8505
Contact: Study Coordinator    +81836222111      
Akita University Hospital ( Site 0433) Recruiting
Akita, Japan, 010-8543
Contact: Study Coordinator    +81188341111      
Harasanshin Hospital ( Site 0402) Recruiting
Fukuoka, Japan, 812-0033
Contact: Study Coordinator    +81922913434      
Kyushu University Hospital ( Site 0413) Recruiting
Fukuoka, Japan, 812-8582
Contact: Study Coordinator    +81926411151      
Kumamoto University Hospital ( Site 0434) Recruiting
Kumamoto, Japan, 860-8556
Contact: Study Coordinator    +81963442111      
Nagano Municipal Hospital ( Site 0429) Recruiting
Nagano, Japan, 381-8551
Contact: Study Coordinator    +81262951199      
Niigata University Medical & Dental Hospital ( Site 0421) Recruiting
Niigata, Japan, 951-8520
Contact: Study Coordinator    +81252236161      
Osaka International Cancer Institute ( Site 0401) Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81669451181      
Osaka City University Hospital ( Site 0428) Recruiting
Osaka, Japan, 545-8586
Contact: Study Coordinator    +81666452121      
Toranomon Hospital ( Site 0426) Recruiting
Tokyo, Japan, 105-8470
Contact: Study Coordinator    +81335881111      
Nippon Medical School Hospital ( Site 0400) Recruiting
Tokyo, Japan, 113-8603
Contact: Study Coordinator    +81338222131      
Keio University Hospital ( Site 0407) Recruiting
Tokyo, Japan, 160-8582
Contact: Study Coordinator    +81333531211      
Toyama University Hospital ( Site 0432) Recruiting
Toyama, Japan, 930-0194
Contact: Study Coordinator    +81764342281      
Korea, Republic of
National Cancer Center ( Site 0304) Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Contact: Study Coordinator    +82319201505      
Seoul National University Hospital ( Site 0302) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    8222072721      
Severance Hospital Yonsei University Health System ( Site 0303) Completed
Seoul, Korea, Republic of, 03722
Asan Medical Center ( Site 0300) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230105977      
Samsung Medical Center ( Site 0301) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82234101767      
Netherlands
Amphia Ziekenhuis Breda ( Site 1901) Recruiting
Breda, Netherlands, 4819 EV
Contact: Study Coordinator    +31765951130      
Poland
Mazowiecki Szpital Onkologiczny ( Site 1316) Completed
Wieliszew, Mazowieckie, Poland, 05-135
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322) Recruiting
Koscierzyna, Pomorskie, Poland, 83-400
Contact: Study Coordinator    +48586860413      
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309) Recruiting
Brzozow, Poland, 36-200
Contact: Study Coordinator    +48508233225      
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307) Recruiting
Bytom, Poland, 41-902
Contact: Study Coordinator    +48323964580      
Wojewodzkie Centrum Onkologii Copernicus ( Site 1304) Recruiting
Gdansk, Poland, 80-219
Contact: Study Coordinator    +48501372012      
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302) Recruiting
Gdynia, Poland, 81-519
Contact: Study Coordinator    +48587260187      
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323) Recruiting
Gliwice, Poland, 44-101
Contact: Study Coordinator    +48501097313      
Przychodnia Lekarska Komed ( Site 1306) Recruiting
Konin, Poland, 62-500
Contact: Study Coordinator    +48632428009      
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310) Recruiting
Krakow, Poland, 31-115
Contact: Study Coordinator    +48126348245      
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315) Recruiting
Lublin, Poland, 20-090
Contact: Study Coordinator         
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324) Recruiting
Otwock, Poland, 05-400
Contact: Study Coordinator    +48601200599      
Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311) Recruiting
Poznan, Poland, 60-569
Contact: Study Coordinator    +48601569568      
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305) Recruiting
Torun, Poland, 87-100
Contact: Study Coordinator    +48566101390      
Centrum Medyczne Onkologii I Hipertermii ( Site 1321) Recruiting
Warszawa, Poland, 02-793
Contact: Study Coordinator    +48607685063      
Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300) Completed
Warszawa, Poland, 04-141
Russian Federation
Ivanovo Regional Oncology Dispensary ( Site 1204) Recruiting
Ivanovo, Russian Federation, 153040
Contact: Study Coordinator    +79106672833      
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210) Recruiting
Krasnoyarsk, Russian Federation, 660133
Contact: Study Coordinator    +79135349316      
N.N. Blokhin NMRCO ( Site 1206) Recruiting
Moscow, Russian Federation, 115478
Contact: Study Coordinator    +79037380779      
Russian Scientific Center of Roentgenoradiology ( Site 1201) Recruiting
Moscow, Russian Federation, 117997
Contact: Study Coordinator    +79166590224      
National Medical Research Radiology Centre ( Site 1200) Recruiting
Moscow, Russian Federation, 125284
Contact: Study Coordinator    +79646228228      
Bayandin Murmansk Regional Clinical Hospital ( Site 1214) Recruiting
Murmansk, Russian Federation, 183057
Contact: Study Coordinator    +79217252994      
Omsk Clinical Oncology Dispensary ( Site 1209) Recruiting
Omsk, Russian Federation, 644013
Contact: Study Coordinator    +79139885114      
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219629807      
Tomsk Scientific Research Institute of Oncology ( Site 1208) Recruiting
Tomsk, Russian Federation, 634028
Contact: Study Coordinator    +79039132574      
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217) Recruiting
Ufa, Russian Federation, 450054
Contact: Study Coordinator    +79373010101      
Clinical Hospital Bashkirsky Medical State University ( Site 1202) Recruiting
Ufa, Russian Federation, 450083
Contact: Study Coordinator    +79373573080      
Spain
Hospital Universitario Infanta Cristina ( Site 1805) Recruiting
Badajoz, Spain, 06080
Contact: Study Coordinator    +3492421804048350      
Hospital de la Santa Creu i Sant Pau ( Site 1807) Recruiting
Barcelona, Spain, 08026
Contact: Study Coordinator    +34932919000      
Hospital de Girona Dr. Josep Trueta ( Site 1806) Recruiting
Girona, Spain, 17007
Contact: Study Coordinator    +34972225828      
Hospital Universitario Gregorio Maranon ( Site 1801) Recruiting
Madrid, Spain, 28007
Contact: Study Coordinator    +34914269393      
Hospital Universitario Ramon y Cajal ( Site 1800) Active, not recruiting
Madrid, Spain, 28034
Hospital Universitario Virgen de la Victoria ( Site 1808) Recruiting
Malaga, Spain, 29010
Contact: Study Coordinator    +34951032508      
Clinica Universitaria de Navarra ( Site 1803) Recruiting
Pamplona, Spain, 31008
Contact: Study Coordinator    +34948255400      
Instituto Valenciano de Oncologia ( Site 1804) Recruiting
Valencia, Spain, 46009
Contact: Study Coordinator    +34961114605      
Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809) Recruiting
Valencia, Spain, 46026
Contact: Study Coordinator    +34961244188      
Taiwan
China Medical University Hospital ( Site 0200) Recruiting
Taichung, Taiwan, 40447
Contact: Study Coordinator    +886422052121      
Taichung Veterans General Hospital ( Site 0204) Recruiting
Taichung, Taiwan, 407
Contact: Study Coordinator    +886423741215      
National Taiwan University Hospital ( Site 0202) Recruiting
Taipei, Taiwan, 10002
Contact: Study Coordinator    886223123456      
Taipei Veterans General Hospital ( Site 0201) Recruiting
Taipei, Taiwan, 112
Contact: Study Coordinator    886228757519*303      
Chang Gung Medical Foundation. Linkou ( Site 0203) Completed
Taoyuan, Taiwan, 333
United Kingdom
North Staffordshire Hospital in Stoke-on-Trent ( Site 1601) Recruiting
Stoke-On-Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: Study Coordinator    +441782672599      
Western General Hospital ( Site 1600) Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Study Coordinator    +441315372211      
The Beatson West of Scotland Cancer Centre ( Site 1605) Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Study Coordinator    +441413017064      
Royal Free Hospital ( Site 1609) Recruiting
London, United Kingdom, NW3 2QG
Contact: Study Coordinator    +442078828505      
St George s Healthcare Trust ( Site 1608) Recruiting
London, United Kingdom, SW17 0QT
Contact: Study Coordinator    +442087523829      
Charing Cross Hospital ( Site 1607) Recruiting
London, United Kingdom, W6 8RF
Contact: Study Coordinator    +442033117627      
The Christie NHS Foundation Trust ( Site 1602) Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Study Coordinator    +441614463000      
The James Cook University Hospital ( Site 1606) Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Study Coordinator    +441642854353      
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: May 23, 2019
Last Verified: May 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