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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03142334
Other study ID # 3475-564
Secondary ID 173704MK-3475-56
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 9, 2017
Est. completion date December 28, 2025

Study information

Verified date June 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. With Protocol Amendment 02 (dated 04 Sep 2019), the secondary study objectives for the evaluation of pharmacokinetic (PK) parameters and the presence of pembrolizumab antidrug antibodies (ADA) were reclassified as tertiary study objectives.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 994
Est. completion date December 28, 2025
Est. primary completion date December 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features - Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment - Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment - Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0 2. High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, =1 year from nephrectomy (metachronous) - Has received no prior systemic therapy for advanced RCC - Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins - Must have undergone a nephrectomy and/or metastasectomy =28 days prior to signing informed consent and =12 weeks prior to randomization - Must be tumor-free as assessed by the Investigator and validated by either computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and chest, abdomen, and pelvis and a bone scan =28 days from randomization - Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available) - Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 - Has adequate organ function Exclusion Criteria: - Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization - Has received prior radiotherapy for RCC - Has pre-existing brain or bone metastatic lesions - Has residual thrombus post nephrectomy in the vena renalis or vena cava - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment - Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed - Has a known additional malignancy that is progressing or required active treatment =3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis - Has an active infection requiring systemic therapy - Has a history of, or is currently on, dialysis - Has a known history of human immunodeficiency virus (HIV) infection - Has known active hepatitis B or hepatitis C virus infection - Has a known history of active tuberculosis (Bacillus tuberculosis) - Has had a prior solid organ transplant - Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 120 days after the last dose of study treatment - Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial - Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (i.e., must be = Grade 1 or at Baseline) from AEs due to previously administered agents - Has received a live vaccine within 30 days prior to the first dose of study treatment - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Pembrolizumab
IV infusion
Drug:
Placebo
IV infusion

Locations

Country Name City State
Argentina Fundacion Favaloro ( Site 1110) Buenos Aires
Argentina Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113) Buenos Aires
Argentina Instituto Medico Alexander Fleming ( Site 1105) Buenos Aires
Argentina Centro Oncologico Riojano Integral ( Site 1101) La Rioja
Argentina Centro Oncologico de Integracion Regional. COIR ( Site 1109) Mendoza
Argentina Instituto de Oncologia de Rosario ( Site 1100) Rosario
Argentina Sanatorio Britanico ( Site 1106) Rosario
Argentina Sanatorio Parque ( Site 1104) Rosario Santa Fe
Argentina Centro Medico San Roque ( Site 1108) Tucuman
Argentina Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102) Viedma Rio Negro
Australia Ballarat Health Services ( Site 0705) Ballarat
Australia Bendigo Cancer Centre ( Site 0704) Bendigo Victoria
Australia Box Hill Hospital ( Site 0701) Box Hill Victoria
Australia Saint George Hospital [Kogarah, Australia] ( Site 0707) Kogarah New South Wales
Australia Adelaide Cancer Centre ( Site 0703) Kurralta Park South Australia
Australia Macquarie University Hospital ( Site 0700) Macquarie Park New South Wales
Australia Fiona Stanley Hospital ( Site 0702) Murdoch Western Australia
Brazil Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002) Barretos Sao Paulo
Brazil Universidade de Caxias do Sul ( Site 1004) Caxias do Sul Rio Grande Do Sul
Brazil Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012) Curitiba PR
Brazil Fundacao Dr Amaral Carvalho ( Site 1005) Jau Sao Paulo
Brazil Hospital Bruno Born ( Site 1015) Lajeado RS
Brazil Liga Norte Riograndense Contra o Cancer ( Site 1013) Natal Rio Grande Do Norte
Brazil Hospital Nossa Senhora da Conceicao ( Site 1000) Porto Alegre RS
Brazil Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001) Porto Alegre RS
Brazil Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016) Ribeirao Preto
Brazil Casa de Saude Santa Marcelina ( Site 1006) Sao Paulo SP
Brazil Instituto do Cancer de Sao Paulo - ICESP ( Site 1010) Sao Paulo SP
Brazil COT Centro Oncologico do Triangulo Ltda ( Site 1014) Uberlandia
Canada William Osler Health System ( Site 0115) Brampton Ontario
Canada CIUSSS du Saguenay-Lac-St-Jean ( Site 0113) Chicoutimi Quebec
Canada Juravinski Cancer Centre ( Site 0117) Hamilton Ontario
Canada CISSS-CA Hotel Dieu de Levis ( Site 0111) Lévis Quebec
Canada London Regional Cancer Program - London HSC ( Site 0107) London Ontario
Canada Dr. Leon Richard Oncology Centre ( Site 0106) Moncton New Brunswick
Canada CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118) Montreal Quebec
Canada Lakeridge Health ( Site 0108) Oshawa Ontario
Canada Allan Blair Cancer Centre ( Site 0116) Regina Saskatchewan
Canada Saskatoon Cancer Centre ( Site 0105) Saskatoon Saskatchewan
Canada St-Jerome Medical Research Inc ( Site 0103) St-Jerome Quebec
Canada Niagara Health System - St. Catharines ( Site 0120) St. Catharines Ontario
Canada CancerCare Manitoba ( Site 0119) Winnipeg Manitoba
Chile Centro Oncologico Antofagasta ( Site 0914) Antofagasta
Chile Hospital Regional de La Serena ( Site 0907) La Serena
Chile Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910) Rancagua
Chile Fundacion Arturo Lopez Perez FALP ( Site 0902) Santiago
Chile Health and Care Chile ( Site 0901) Santiago
Chile Hospital Clinico Universidad de Chile ( Site 0905) Santiago
Chile Hospital Militar de Santiago ( Site 0911) Santiago
Chile Instituto Nacional del Cancer ( Site 0912) Santiago Region Metropolitana
Chile Iram Cancer Research ( Site 0909) Santiago
Chile Pontificia Universidad Catolica de Chile ( Site 0904) Santiago
Chile Sociedad de Investigaciones Medicas Limitadas ( Site 0913) Temuco
Chile Oncocentro ( Site 0900) Vina del Mar
Colombia Clinica de la Costa Ltda. ( Site 0804) Barranquilla Atlantico
Colombia Administradora Country SA - Clinica del Country ( Site 0808) Bogota
Colombia Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803) Bogota
Colombia Instituto Nacional de Cancerologia E.S.E ( Site 0807) Bogota Cundinamarca
Colombia Hospital Pablo Tobon Uribe. ( Site 0805) Medellin Antioquia
Colombia Oncomedica S.A. ( Site 0801) Monteria
Colombia Oncologos del Occidente S.A. ( Site 0800) Pereira Risaralda
Colombia Sociedad de Hematologia y Oncologia del Cesar ( Site 0809) Valledupar Cesar
Czechia FN Brno. ( Site 1501) Brno
Czechia Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506) Novy Jicin
Czechia Fakultni nemocnice Olomouc ( Site 1502) Olomouc
Czechia Fakultni nemocnice Ostrava ( Site 1507) Ostrava
Czechia Thomayerova nemocnice ( Site 1505) Praha 4
Czechia Fakultni nemocnice v Motole ( Site 1504) Praha 5
Czechia Nemocnice Na Bulovce ( Site 1503) Praha 8
Finland HYKS ( Site 2300) Helsinki
Finland Keski-Suomen keskussairaala ( Site 2303) Jyvaskyla
Finland Oulun yliopistollinen sairaala - OYS ( Site 2304) Oulu
Finland TAYS ( Site 2301) Tampere
Finland TYKS ( Site 2302) Turku
France ICO Centre Paul Papin ( Site 2208) Angers
France CHU Besancon - Hopital Jean Minjoz ( Site 2200) Besancon
France Hopital Saint Andre ( Site 2202) Bordeaux
France Hopital La Timone ( Site 2204) Marseille
France CHU Saint-Eloi ( Site 2203) Montpellier
France Centre Antoine Lacassagne ( Site 2211) Nice
France Hopital Europeen Georges Pompidou ( Site 2206) Paris
France Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212) Pierre Benite
France Centre Eugene Marquis ( Site 2209) Rennes
France Centre Rene Gauducheau ICO ( Site 2207) Saint Herblain
France Institut Claudius Regaud IUCT Oncopole ( Site 2201) Toulouse
Germany Campus Charite Mitte ( Site 2120) Berlin
Germany Helios Klinikum Berlin Buch ( Site 2125) Berlin
Germany Universitaetsklinikum Bonn ( Site 2110) Bonn
Germany Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113) Dresden
Germany Universitatsklinikum Dusseldorf ( Site 2108) Dusseldorf
Germany Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102) Erlangen
Germany Universitaetsklinikum Essen ( Site 2116) Essen
Germany Universitaetsklinikum Frankfurt ( Site 2121) Frankfurt
Germany Universitaetsklinikum Freiburg ( Site 2119) Freiburg
Germany Universitaetsklinikum Hamburg-Eppendorf ( Site 2118) Hamburg
Germany Universitaetsklinikum Jena. ( Site 2104) Jena
Germany Universitaetsklinikum Schleswig Holstein ( Site 2109) Luebeck
Germany Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111) Mainz
Germany Studienpraxis Urologie ( Site 2115) Nuertingen
Germany Krankenhaus der Barmherzigen Brueder Trier ( Site 2117) Trier
Germany Universitaetsklinikum Tuebingen ( Site 2100) Tuebingen
Ireland Beaumont Hospital ( Site 1611) Dublin
Ireland St Vincents University Hospital ( Site 1610) Dublin
Ireland University Hospital Waterford ( Site 1614) Waterford
Italy Medical Oncology Ospedale San Donato ( Site 2004) Arezzo
Italy Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012) Meldola
Italy Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005) Milano
Italy Istituto Europeo di Oncologia ( Site 2000) Milano
Italy Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006) Modena
Italy Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003) Napoli
Italy Ospedale San Luigi Gonzaga ( Site 2010) Orbassano Torino
Italy Istituto Nazionale Tumori Regina Elena ( Site 2009) Roma
Japan Akita University Hospital ( Site 0433) Akita
Japan Harasanshin Hospital ( Site 0402) Fukuoka
Japan Kyushu University Hospital ( Site 0413) Fukuoka
Japan Saitama Medical University International Medical Center ( Site 0404) Hidaka Saitama
Japan Nara Medical University Hospital ( Site 0416) Kashihara Nara
Japan Kagawa University Hospital ( Site 0419) Kita-gun Kagawa
Japan Kumamoto University Hospital ( Site 0434) Kumamoto
Japan Nagano Municipal Hospital ( Site 0429) Nagano
Japan Nagoya University Hospital ( Site 0431) Nagoya Aichi
Japan Niigata University Medical & Dental Hospital ( Site 0421) Niigata
Japan Osaka City University Hospital ( Site 0428) Osaka
Japan Osaka International Cancer Institute ( Site 0401) Osaka
Japan Kindai University Hospital ( Site 0411) Osakasayama Osaka
Japan Osaka Rosai Hospital ( Site 0418) Sakai Osaka
Japan Sapporo Medical University Hospital ( Site 0424) Sapporo Hokkaido
Japan Japan Community Health care Organization Sendai Hospital ( Site 0430) Sendai Miyagi
Japan Keio University Hospital ( Site 0407) Tokyo
Japan Nippon Medical School Hospital ( Site 0400) Tokyo
Japan Toranomon Hospital ( Site 0426) Tokyo
Japan Toyama University Hospital ( Site 0432) Toyama
Japan Yamaguchi University Hospital ( Site 0406) Ube Yamaguchi
Korea, Republic of National Cancer Center ( Site 0304) Goyang-si Gyeonggi-do
Korea, Republic of Asan Medical Center ( Site 0300) Seoul
Korea, Republic of Samsung Medical Center ( Site 0301) Seoul
Korea, Republic of Seoul National University Hospital ( Site 0302) Seoul
Korea, Republic of Severance Hospital Yonsei University Health System ( Site 0303) Seoul
Netherlands Amphia Ziekenhuis Breda ( Site 1901) Breda
Netherlands Maastricht Universitair Medisch Centrum - MUMC ( Site 1902) Maastricht
Netherlands Franciscus Gasthuis ( Site 1903) Rotterdam
Poland Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309) Brzozow
Poland Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307) Bytom
Poland Wojewodzkie Centrum Onkologii Copernicus ( Site 1304) Gdansk
Poland Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302) Gdynia
Poland Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1323) Gliwice
Poland Przychodnia Lekarska Komed ( Site 1306) Konin
Poland Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322) Koscierzyna Pomorskie
Poland Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310) Krakow
Poland Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315) Lublin
Poland Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324) Otwock
Poland Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311) Poznan
Poland Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305) Torun
Poland Centrum Medyczne Onkologii I Hipertermii ( Site 1321) Warszawa
Poland Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300) Warszawa
Poland Mazowiecki Szpital Onkologiczny ( Site 1316) Wieliszew Mazowieckie
Russian Federation Ivanovo Regional Oncology Dispensary ( Site 1204) Ivanovo
Russian Federation Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210) Krasnoyarsk
Russian Federation N.N. Blokhin NMRCO ( Site 1206) Moscow
Russian Federation National Medical Research Radiology Centre ( Site 1200) Moscow
Russian Federation Russian Scientific Center of Roentgenoradiology ( Site 1201) Moscow
Russian Federation Bayandin Murmansk Regional Clinical Hospital ( Site 1214) Murmansk
Russian Federation Omsk Clinical Oncology Dispensary ( Site 1209) Omsk
Russian Federation Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205) Saint Petersburg
Russian Federation Tomsk Scientific Research Institute of Oncology ( Site 1208) Tomsk
Russian Federation Clinical Hospital Bashkirsky Medical State University ( Site 1202) Ufa
Russian Federation Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217) Ufa
Spain Hospital Universitario Infanta Cristina ( Site 1805) Badajoz
Spain Hospital de la Santa Creu i Sant Pau ( Site 1807) Barcelona
Spain Hospital de Girona Dr. Josep Trueta ( Site 1806) Girona
Spain Hospital Universitario Gregorio Maranon ( Site 1801) Madrid
Spain Hospital Universitario Ramon y Cajal ( Site 1800) Madrid
Spain Hospital Universitario Virgen de la Victoria ( Site 1808) Malaga
Spain Clinica Universitaria de Navarra ( Site 1803) Pamplona
Spain Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809) Valencia
Spain Instituto Valenciano de Oncologia ( Site 1804) Valencia
Taiwan China Medical University Hospital ( Site 0200) Taichung
Taiwan Taichung Veterans General Hospital ( Site 0204) Taichung
Taiwan National Taiwan University Hospital ( Site 0202) Taipei
Taiwan Taipei Veterans General Hospital ( Site 0201) Taipei
Taiwan Chang Gung Medical Foundation. Linkou ( Site 0203) Taoyuan
United Kingdom Western General Hospital ( Site 1600) Edinburgh
United Kingdom The Beatson West of Scotland Cancer Centre ( Site 1605) Glasgow
United Kingdom Charing Cross Hospital ( Site 1607) London
United Kingdom Royal Free Hospital ( Site 1609) London
United Kingdom St George s Healthcare Trust ( Site 1608) London
United Kingdom The Christie NHS Foundation Trust ( Site 1602) Manchester
United Kingdom The James Cook University Hospital ( Site 1606) Middlesbrough
United Kingdom North Staffordshire Hospital in Stoke-on-Trent ( Site 1601) Stoke-On-Trent Staffordshire
United States University of New Mexico Cancer Center ( Site 0043) Albuquerque New Mexico
United States McFarland Clinic ( Site 0025) Ames Iowa
United States University of Michigan ( Site 0045) Ann Arbor Michigan
United States Rocky Mountain Cancer Center ( Site 8010) Aurora Colorado
United States Texas Oncology-Austin Central ( Site 8003) Austin Texas
United States Weinberg Cancer Institute at Franklin Square ( Site 0046) Baltimore Maryland
United States St. Vincent Healthcare Frontier Cancer Center ( Site 0008) Billings Montana
United States Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035) Boca Raton Florida
United States Beth Israel Deaconess Medical Ctr. ( Site 0044) Boston Massachusetts
United States Dana-Farber Cancer Institute (Boston) ( Site 0007) Boston Massachusetts
United States Manatee Medical Research Institute ( Site 0039) Bradenton Florida
United States Montefiore Medical Center ( Site 0009) Bronx New York
United States Charleston Hematology Oncology Associates PA ( Site 8000) Charleston South Carolina
United States Medical University of South Carolina ( Site 0033) Charleston South Carolina
United States Oncology Hematology Care, Inc. ( Site 8008) Cincinnati Ohio
United States Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019) Dallas Texas
United States UT Southwestern Medical Center ( Site 0003) Dallas Texas
United States Texas Oncology-Denton South ( Site 8016) Denton Texas
United States Henry Ford Hospital ( Site 0032) Detroit Michigan
United States Karmanos Cancer Institute ( Site 0013) Detroit Michigan
United States Duke University ( Site 0037) Durham North Carolina
United States St. Luke's University Health Network ( Site 0042) Easton Pennsylvania
United States Fairview Southdale Medical Oncology Clinic ( Site 0041) Edina Minnesota
United States Providence Regional Cancer Partnership ( Site 0016) Everett Washington
United States MD Anderson Cancer Center ( Site 0065) Houston Texas
United States Texas Oncology-Memorial City ( Site 8015) Houston Texas
United States UTHealth/Memorial Hermann Cancer Center ( Site 0001) Houston Texas
United States University of Iowa Hospital and Clinics ( Site 0031) Iowa City Iowa
United States Comprehensive Cancer Centers of Nevada ( Site 8013) Las Vegas Nevada
United States USC Norris Comprehensive Cancer Center ( Site 0038) Los Angeles California
United States University of Wisconsin Carbone Cancer Center ( Site 0019) Madison Wisconsin
United States Northwest Georgia Oncology Centers PC ( Site 0014) Marietta Georgia
United States Minnesota Oncology Specialist, PA ( Site 8002) Minneapolis Minnesota
United States Urology Associates [Nashville, TN] ( Site 0063) Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey ( Site 0059) New Brunswick New Jersey
United States University Medical Center New Orleans ( Site 0053) New Orleans Louisiana
United States Illinois Cancer Specialists ( Site 8001) Niles Illinois
United States Virginia Oncology Associates ( Site 8011) Norfolk Virginia
United States Nebraska Cancer Specialists ( Site 0012) Omaha Nebraska
United States Texas Oncology- Paris ( Site 8004) Paris Texas
United States Woodlands Medical Specialists, PA ( Site 8021) Pensacola Florida
United States Abramson Cancer Center ( Site 0010) Philadelphia Pennsylvania
United States Arizona Oncology Associates, PC- HAL ( Site 8018) Phoenix Arizona
United States Maryland Oncology Hematology, P.A. ( Site 8020) Rockville Maryland
United States Quest Research Institute ( Site 0036) Royal Oak Michigan
United States Park Nicollet Frauenshuh Cancer Center ( Site 0020) Saint Louis Park Minnesota
United States IHO Corporation- Utah Cancer Specialists ( Site 0055) Salt Lake City Utah
United States CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026) San Antonio Texas
United States UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056) San Francisco California
United States Sansum Clinic Research ( Site 8014) Santa Barbara California
United States SCCA/UW ( Site 0029) Seattle Washington
United States Avera Cancer Institute ( Site 0023) Sioux Falls South Dakota
United States Cancer Care Northwest ( Site 0021) Spokane Washington
United States Medical Oncology Associates (Summit Cancer Centers) ( Site 0005) Spokane Washington
United States Stanford Cancer Center ( Site 0028) Stanford California
United States Northwest Medical Specialties, PLLC ( Site 0034) Tacoma Washington
United States Northwest Cancer Specialists, P.C. ( Site 8006) Tigard Oregon
United States Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052) Tulsa Oklahoma
United States Texas Oncology-Tyler ( Site 8005) Tyler Texas
United States Texas Oncology-Waco ( Site 8012) Waco Texas
United States Georgetown University Medical Center ( Site 0002) Washington District of Columbia
United States Yakima Valley Memorial Hospital North Star Lodge ( Site 8017) Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  Colombia,  Czechia,  Finland,  France,  Germany,  Ireland,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free Survival (DFS) as Assessed by the Investigator DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs). Up to approximately 42 months (database cutoff date 14 Dec 2020)
Secondary Overall Survival (OS) OS was defined as the time from randomization to death due to any cause. Up to approximately 72 months
Secondary Number of Participants Who Experienced an Adverse Event (AE) 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. Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
Secondary Number of Participants Who Discontinued Study Drug Due to an AE 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. Up to approximately 12 months
Secondary First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator 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. Up to approximately 72 months
Secondary Second Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by the investigator. Up to approximately 72 months
Secondary Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR) EFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first. Up to approximately 72 months
Secondary DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. The PD-L1 expression status is based on combined positive score (CPS). If CPS is = 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative. Up to approximately 72 months
Secondary OS According to Participant PD-L1 Expression Status (Positive, Negative) OS is defined as the time from randomization to death due to any cause. The PD-L1 expression status is based on combined positive score (CPS). If CPS is = 1, PD-L1 expression status is positive and if the CPS is <1, PD-L1 expression status is negative. Up to approximately 72 months
Secondary Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score 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. Baseline and Week 52
Secondary Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score 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. The change from baseline in the FKSI-DRS index score will be presented. Baseline and Week 52
See also
  Status Clinical Trial Phase
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Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Completed NCT02853344 - Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) Phase 2
Terminated NCT04088500 - A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma Phase 2
Completed NCT05070637 - Circulating Tumor Cell Reducing No-touch Nephrectomy N/A
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Not yet recruiting NCT06049030 - A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1
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Completed NCT01358721 - Phase I Biomarker Study (BMS-936558) Phase 1
Active, not recruiting NCT04503148 - Anesthesia and Cancer Study: Renal Cell Carcinoma N/A
Completed NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Not yet recruiting NCT05808608 - A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma Phase 1/Phase 2
Withdrawn NCT03323710 - Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma Phase 2
Not yet recruiting NCT02787915 - DC1s-CTL Cellular Therapy for Renal Cell Carcinoma Phase 1/Phase 2