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)
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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 |
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Recruitment Status :
Recruiting
First Posted : May 5, 2017
Last Update Posted : May 23, 2019
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 |
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.
| 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
Drug Information available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles.
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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.
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Drug: Placebo (saline solution)
IV infusion
Other Name: saline solution |
Primary Outcome Measures :
- 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 :
- Overall Survival (OS) [ Time Frame: Up to approximately 72 months ]OS is defined as the time from randomization to death due to any cause.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
| 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.
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Has intermediate-high risk, high risk, or M1 NED RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:
- Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0
- High risk RCC: pT4, Any Grade N0, M0; pT, Any stage, Any Grade, N+, M0
- 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
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
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Locations
| 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
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
| 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 |
| 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:
|
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 |