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)
Public ClinicalTrials.gov record NCT03142334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03142334
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 994 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2017 (Actual)
- Primary completion
- Dec 14, 2020 (Actual)
- Completion
- Feb 4, 2026 (Actual)
- Last update posted
- Mar 10, 2026
2017 – 2026
United States locations
- U.S. sites
- 62
- U.S. states
- 32
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, PC- HAL ( Site 8018) | Phoenix | Arizona | 85016 | — |
| USC Norris Comprehensive Cancer Center ( Site 0038) | Los Angeles | California | 90033 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056) | San Francisco | California | 94158 | — |
| Sansum Clinic Research ( Site 8014) | Santa Barbara | California | 93105 | — |
| Stanford Cancer Center ( Site 0028) | Stanford | California | 94305 | — |
| Rocky Mountain Cancer Center ( Site 8010) | Aurora | Colorado | 80012 | — |
| Georgetown University Medical Center ( Site 0002) | Washington D.C. | District of Columbia | 20007 | — |
| Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035) | Boca Raton | Florida | 33486 | — |
| Manatee Medical Research Institute ( Site 0039) | Bradenton | Florida | 34205 | — |
| Woodlands Medical Specialists, PA ( Site 8021) | Pensacola | Florida | 32503 | — |
| Northwest Georgia Oncology Centers PC ( Site 0014) | Marietta | Georgia | 30060 | — |
| Illinois Cancer Specialists ( Site 8001) | Niles | Illinois | 60714 | — |
| McFarland Clinic ( Site 0025) | Ames | Iowa | 50010-3014 | — |
| University of Iowa Hospital and Clinics ( Site 0031) | Iowa City | Iowa | 52242 | — |
| University Medical Center New Orleans ( Site 0053) | New Orleans | Louisiana | 70112 | — |
| Weinberg Cancer Institute at Franklin Square ( Site 0046) | Baltimore | Maryland | 21237 | — |
| Maryland Oncology Hematology, P.A. ( Site 8020) | Rockville | Maryland | 20850 | — |
| Beth Israel Deaconess Medical Ctr. ( Site 0044) | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute (Boston) ( Site 0007) | Boston | Massachusetts | 02215 | — |
| University of Michigan ( Site 0045) | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute ( Site 0013) | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital ( Site 0032) | Detroit | Michigan | 48202 | — |
| Quest Research Institute ( Site 0036) | Royal Oak | Michigan | 48073 | — |
| Fairview Southdale Medical Oncology Clinic ( Site 0041) | Edina | Minnesota | 55435 | — |
| Minnesota Oncology Specialist, PA ( Site 8002) | Minneapolis | Minnesota | 55404 | — |
| Park Nicollet Frauenshuh Cancer Center ( Site 0020) | Saint Louis Park | Minnesota | 55426 | — |
| St. Vincent Healthcare Frontier Cancer Center ( Site 0008) | Billings | Montana | 59102 | — |
| Nebraska Cancer Specialists ( Site 0012) | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada ( Site 8013) | Las Vegas | Nevada | 89148 | — |
| Rutgers Cancer Institute of New Jersey ( Site 0059) | New Brunswick | New Jersey | 08903 | — |
| University of New Mexico Cancer Center ( Site 0043) | Albuquerque | New Mexico | 87106 | — |
| Montefiore Medical Center ( Site 0009) | The Bronx | New York | 10461 | — |
| Duke University ( Site 0037) | Durham | North Carolina | 27710 | — |
| Oncology Hematology Care, Inc. ( Site 8008) | Cincinnati | Ohio | 45242 | — |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052) | Tulsa | Oklahoma | 74146 | — |
| Northwest Cancer Specialists, P.C. ( Site 8006) | Tigard | Oregon | 97223 | — |
| St. Luke's University Health Network ( Site 0042) | Easton | Pennsylvania | 18045 | — |
| Abramson Cancer Center ( Site 0010) | Philadelphia | Pennsylvania | 19104 | — |
| Charleston Hematology Oncology Associates PA ( Site 8000) | Charleston | South Carolina | 29414 | — |
| Medical University of South Carolina ( Site 0033) | Charleston | South Carolina | 29425 | — |
| Avera Cancer Institute ( Site 0023) | Sioux Falls | South Dakota | 57105 | — |
| Urology Associates [Nashville, TN] ( Site 0063) | Nashville | Tennessee | 37209 | — |
| Texas Oncology-Austin Central ( Site 8003) | Austin | Texas | 78731 | — |
| Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019) | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center ( Site 0003) | Dallas | Texas | 75390 | — |
| Texas Oncology-Denton South ( Site 8016) | Denton | Texas | 76210 | — |
| Texas Oncology-Memorial City ( Site 8015) | Houston | Texas | 77024 | — |
| MD Anderson Cancer Center ( Site 0065) | Houston | Texas | 77030 | — |
| UTHealth/Memorial Hermann Cancer Center ( Site 0001) | Houston | Texas | 77030 | — |
| Texas Oncology- Paris ( Site 8004) | Paris | Texas | 75460-5004 | — |
| CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026) | San Antonio | Texas | 78229 | — |
| Texas Oncology-Tyler ( Site 8005) | Tyler | Texas | 75702 | — |
| Texas Oncology-Waco ( Site 8012) | Waco | Texas | 76712 | — |
| IHO Corporation- Utah Cancer Specialists ( Site 0055) | Salt Lake City | Utah | 84106 | — |
| Virginia Oncology Associates ( Site 8011) | Norfolk | Virginia | 23502 | — |
| Providence Regional Cancer Partnership ( Site 0016) | Everett | Washington | 98201 | — |
| SCCA/UW ( Site 0029) | Seattle | Washington | 98109 | — |
| Cancer Care Northwest ( Site 0021) | Spokane | Washington | 99202 | — |
| Medical Oncology Associates (Summit Cancer Centers) ( Site 0005) | Spokane | Washington | 99208 | — |
| Northwest Medical Specialties, PLLC ( Site 0034) | Tacoma | Washington | 98405 | — |
| Yakima Valley Memorial Hospital North Star Lodge ( Site 8017) | Yakima | Washington | 98902 | — |
| University of Wisconsin Carbone Cancer Center ( Site 0019) | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 189 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03142334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 10, 2026 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03142334 live on ClinicalTrials.gov.