Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Study ID: NCT03833167
Conditions
Study Description
Brief Summary: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama, Mitchell Cancer Institute ( Site 1562), Mobile, Alabama, United States
City of Hope Medical Center ( Site 1505), Duarte, California, United States
UCSD Moores Cancer Center ( Site 1561), La Jolla, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568), Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center ( Site 1560), Sacramento, California, United States
Stanford University Medical Center ( Site 1503), Stanford, California, United States
University of Colorado Cancer Center ( Site 1506), Aurora, Colorado, United States
Smilow Cancer Center at Yale-New Haven ( Site 1507), New Haven, Connecticut, United States
Boca Raton Regional Hospital ( Site 1551), Boca Raton, Florida, United States
UF Health ( Site 1511), Gainesville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544), Miami, Florida, United States
Winship Cancer Institute of Emory University ( Site 1512), Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 1515), Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics ( Site 1514), Iowa City, Iowa, United States
University of Kentucky School of Medicine & Hospitals ( Site 1542), Lexington, Kentucky, United States
Massachusetts General Hospital ( Site 1518), Boston, Massachusetts, United States
Dana Farber Cancer Center ( Site 1519), Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526), Hackensack, New Jersey, United States
Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565), Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 1575), New York, New York, United States
Cleveland Clinic ( Site 1541), Cleveland, Ohio, United States
Providence Portland Medical Center ( Site 1530), Portland, Oregon, United States
UPMC Hillman Cancer Center ( Site 1570), Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center ( Site 1533), Charleston, South Carolina, United States
West Cancer Center - East Campus ( Site 1535), Germantown, Tennessee, United States
Vanderbilt Ingram Cancer Center ( Site 1543), Nashville, Tennessee, United States
The University of Texas-MD Anderson Cancer Center ( Site 1536), Houston, Texas, United States
Huntsman Cancer Institute ( Site 1537), Salt Lake City, Utah, United States
Inova Schar Cancer Institute ( Site 1538), Fairfax, Virginia, United States
West Virginia University ( Site 1569), Morgantown, West Virginia, United States
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro Medico Privado CEMAIC ( Site 0024), Capital, Cordoba, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0026), Rosario, Santa Fe, Argentina
Centro Oncológico de Rosario ( Site 0003), Rosario, Santa Fe, Argentina
Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009), Buenos Aires, , Argentina
CEMIC ( Site 0012), Buenos Aires, , Argentina
Fundacion CIDEA ( Site 0001), Caba, , Argentina
Centro Oncologico Riojano Integral ( Site 0002), La Rioja, , Argentina
Centro Oncologico Norte ( Site 0023), Santiago del Estero, , Argentina
Chris OBrien Lifehouse ( Site 0051), Camperdown, New South Wales, Australia
Lismore Base Hospital ( Site 0050), Lismore, New South Wales, Australia
Orange Health Services ( Site 0053), Orange, New South Wales, Australia
Royal North Shore Hospital ( Site 0052), St Leonards, New South Wales, Australia
Gold Coast University Hospital ( Site 0054), Southport, Queensland, Australia
Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056), Sunshine Coast, Queensland, Australia
Alfred Health ( Site 0055), Melbourne, Victoria, Australia
Oncocentro Ceara ( Site 0108), Fortaleza, Ceara, Brazil
Hospital Erasto Gaertner ( Site 0101), Curitiba, Parana, Brazil
Hospital Tacchini ( Site 0111), Bento Goncalves, Rio Grande Do Sul, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100), Ijui, Rio Grande Do Sul, Brazil
Hospital Bruno Born ( Site 0107), Lajeado, Rio Grande Do Sul, Brazil
Hospital Sao Vicente de Paulo ( Site 0105), Passo Fundo, Rio Grande Do Sul, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103), Rio de Janeiro, , Brazil
A. C. Camargo Cancer Center ( Site 0116), Sao Paulo, , Brazil
Tom Baker Cancer Center ( Site 0161), Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0159), Edmonton, Alberta, Canada
Juravinski Cancer Center ( Site 0151), Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre ( Site 0154), Ottawa, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0162), Montréal, Quebec, Canada
James Lind Centro de Investigación del Cáncer ( Site 1653), Temuco, Araucania, Chile
Enroll SpA ( Site 1654), Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 1651), Santiago, Region M. De Santiago, Chile
Bradford Hill Norte ( Site 1652), Antofagasta, , Chile
Oncomedica S.A. ( Site 0205), Monteria, Cordoba, Colombia
Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201), Bogota, Distrito Capital De Bogota, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0204), Bogota, Distrito Capital De Bogota, Colombia
Oncologos del Occidente S.A. ( Site 0206), Pereira, Risaralda, Colombia
Fundación Cardiovascular de Colombia ( Site 0207), Piedecuesta, Santander, Colombia
Fundación Valle del Lili ( Site 0202), Cali, Valle Del Cauca, Colombia
Hopital ARCHET 2 ( Site 0356), Nice, Alpes-Maritimes, France
Hopital Saint Joseph ( Site 0376), Marseille, Bouches-du-Rhone, France
Hopital La Timone ( Site 0353), Marseille, Bouches-du-Rhone, France
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365), Caen, Calvados, France
CHU Besancon - Hopital Jean Minjoz ( Site 0359), Besancon, Doubs, France
Centre Hospitalier de Valence ( Site 0377), Valence, Drome, France
C.H.U. de Nimes. Hopital Caremeau ( Site 0368), Nimes, Gard, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0370), Bordeaux, Gironde, France
Institut Claudius Regaud IUCT Oncopole ( Site 0354), Toulouse, Haute-Garonne, France
Centre Hospitalier Annecy Genevois ( Site 0361), Pringy, Haute-Savoie, France
CHU Montpellier. ( Site 0367), Montpellier, Herault, France
CHRU de Lille - Hopital Claude Huriez ( Site 0355), Lille, Nord, France
CHU Estaing ( Site 0360), Clermont-Ferrand, Puy-de-Dome, France
CH Lyon Sud Hospices Civils de Lyon ( Site 0350), Pierre Benite, Rhone, France
Hopital Avicenne ( Site 0358), Bobigny, Seine-Saint-Denis, France
Institut Gustave Roussy ( Site 0352), Villejuif, Val-de-Marne, France
CHU Poitiers ( Site 0375), Poitiers, Vienne, France
Universitaetsklinikum Tuebingen ( Site 0409), Tuebingen, Baden-Wurttemberg, Germany
Klinikum Nürnberg Nord ( Site 0415), Nürnberg, Bayern, Germany
Universitatsklinikum Giessen und Marburg GmbH ( Site 0413), Marburg, Hessen, Germany
Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411), Buxtehude, Niedersachsen, Germany
Medizinische Hochschule Hannover ( Site 0405), Hannover, Niedersachsen, Germany
Universitaetsklinikum Essen ( Site 0403), Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400), Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0414), Hamburg, , Germany
Andreas Syggros Hospital ( Site 0450), Athens, Achaia, Greece
Attikon University General Hospital of Athens ( Site 0454), Chaidari, Attiki, Greece
Metropolitan Hospital ( Site 0453), Neo Faliro, Attiki, Greece
Papageorgiou General Hospital ( Site 0451), Thessaloniki, , Greece
European Interbalkan Medical Center ( Site 0455), Thessaloniki, , Greece
Pecsi Tudomanyegyetem AOK ( Site 0501), Pecs, Baranya, Hungary
Szegedi Tudomanyegyetem ( Site 0504), Szeged, Csongrad, Hungary
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500), Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Debreceni Egyetem. ( Site 0506), Debrecen, Vas, Hungary
Semmelweis Egyetem ( Site 0507), Budapest, , Hungary
Szent Imre Egyetemi Oktatokorhaz ( Site 0502), Budapest, , Hungary
St. James s Hospital ( Site 1601), Dublin 8, Dublin, Ireland
Soroka University Medical Center ( Site 0555), Beer Sheva, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0552), Haifa, , Israel
Haddassah Medical Organization - Ein Kerem ( Site 0553), Jerusalem, , Israel
Meir Medical Center ( Site 0556), Kfar-Saba, , Israel
Rabin Medical Center ( Site 0550), Petah Tiqwa, , Israel
Chaim Sheba Medical Center ( Site 0551), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0554), Tel-Aviv, , Israel
Instituto Tumori Giovanni Paolo II ( Site 0604), Bari, Puglia, Italy
Azienda Ospedaliero Universitaria Pisana ( Site 0603), Pisa, Toscana, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600), Milano, , Italy
Istituto Europeo di Oncologia ( Site 0602), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601), Napoli, , Italy
San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722), Tuxtla Gutierrez, Chiapas, Mexico
Cimab SA de CV ( Site 0708), Torreon, Coahuila, Mexico
Centro de Investigación Clínica de Alta Especialidad ( Site 0715), Torreón, Coahuila, Mexico
Onco-Hematologia de Occidente ( Site 0716), Guadalajara, Jalisco, Mexico
Hospital de Especialidades Centro Medico de Occidente ( Site 0704), Guadalajara, Jalisco, Mexico
Consultorios de Medicina Especializada del Sector Privado ( Site 0701), Guadalajara, Jalisco, Mexico
Centro de atencion e investigacion clinica en oncologia ( Site 0706), Merida, Yucatan, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0703), Chihuahua, , Mexico
FAICIC Clinical Research ( Site 0700), Veracruz, , Mexico
New Zealand Clinical Research (Auckland) ( Site 0800), Auckland, , New Zealand
Haukeland sykehus ( Site 0851), Bergen, Hordaland, Norway
St. Olavs Hospital HF ( Site 0852), Trondheim, Sor-Trondelag, Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 0850), Oslo, , Norway
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951), Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site, Gdańsk, Pomorskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958), Gliwice, Slaskie, Poland
Hospital Particular do Algarve ( Site 1005), Faro, , Portugal
Instituto Portugues de Oncologia de Lisboa ( Site 1003), Lisboa, , Portugal
Hospital CUF - Tejo ( Site 1004), Lisboa, , Portugal
CHLN Hospital Santa Maria ( Site 1001), Lisboa, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000), Porto, , Portugal
S C Pelican Impex SRL ( Site 1108), Oradea, Bihor, Romania
Hifu Terramed Conformal SRL ( Site 1111), Bucharest, Bucuresti, Romania
Cardiomed SRL Cluj-Napoca ( Site 1104), Cluj-Napoca, Cluj, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113), Cluj-Napoca, Cluj, Romania
Spitalul Universitar CF Cluj-Napoca ( Site 1103), Cluj-Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101), Craiova, Dolj, Romania
S C Oncocenter Oncologie Medicala S R L ( Site 1106), Timisoara, Timis, Romania
Policlinica Oncomed SRL ( Site 1105), Timisoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 1107), Bucuresti, , Romania
Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112), Bucuresti, , Romania
Altay Regional Oncology Dispensary ( Site 1168), WBarnaularsaw, Altayskiy Kray, Russian Federation
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171), Ufa, Baskortostan, Respublika, Russian Federation
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological, Obninsk, Kaluzskaja Oblast, Russian Federation
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159), Sochi, Krasnodarskiy Kray, Russian Federation
Hadassah Medical-Oncology department ( Site 1173), Moscow, Moskovskaya Oblast, Russian Federation
N.N. Blokhin NMRCO ( Site 1153), Moscow, Moskva, Russian Federation
FSCC FMBA of Russia ( Site 1163), Moscow, Moskva, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164), Moscow, Moskva, Russian Federation
Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169), Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
Railway Hospital of OJSC ( Site 1161), Saint Petersburg, Sankt-Peterburg, Russian Federation
Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158), Izhevsk, Udmurtskaya Respublika, Russian Federation
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152), Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Hospital Duran i Reynals ( Site 1254), Hospitalet del Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla ( Site 1256), Santander, Cantabria, Spain
Hospital Clinic i Provincial Barcelona ( Site 1253), Barcelona, Cataluna, Spain
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258), Doniostia - San Sebastian, Gipuzkoa, Spain
Hospital General Universitari Vall d Hebron ( Site 1252), Barcelona, , Spain
Hospital Universitario Ramon y Cajal ( Site 1251), Madrid, , Spain
Hospital Universitario Carlos Haya ( Site 1255), Malaga, , Spain
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (, Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450), Kharkiv, Kharkivska Oblast, Ukraine
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451), Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452), Sumy, Sumska Oblast, Ukraine
Universal Clinic Oberig-Oncology Center ( Site 1461), Kyiv, , Ukraine
Royal Cornwall Hospitals NHS Trust ( Site 1402), Truro, Cornwall, United Kingdom
University College Hospital London ( Site 1400), London, London, City Of, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 1407), London, London, City Of, United Kingdom
The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406), London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1408), Sutton, London, City Of, United Kingdom
Churchill Hospital ( Site 1404), Oxford, Oxfordshire, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
