Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma... | NCT03833167 | Trialant

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma... | NCT03833167 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted)

Has histologically confirmed locally advanced cutaneous squamous cell carcinoma (LA cSCC) with ≥1 high-risk feature(s) as the primary site of malignancy

Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided

Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization

Has received an adequate post-op dose of RT (either hypofractionated or conventional)

Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization

Is not pregnant or breastfeeding

Is not a person of childbearing potential (POCBP)

Has a negative pregnancy test ≤72 hours before the first dose of study intervention.

Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing

Has a life expectancy of >3 months

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention.

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization

Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma

Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another costimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)

Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to before start of study intervention.

Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis

Has received a live vaccine ≤30 days prior to the first dose of study intervention

Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.

Has known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Other exceptions may be considered with Sponsor consultation. Note: Participants with low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation. Early stage asymptomatic CLL without prior treatment and without any of the risk features (unmutated IGHV, lymphocytes >15,000μL, palpable lymph nodes) will be eligible for the study

Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).

Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Has an active infection requiring systemic therapy

Has a known history of human immunodeficiency virus (HIV) infection

Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection

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 intervention

Has had an allogeneic tissue/solid organ transplant

University of South Alabama, Mitchell Cancer Institute ( Site 1562)

Mobile, Alabama 36604, United States

City of Hope Medical Center ( Site 1505)

Duarte, California 91010, United States

UCSD Moores Cancer Center ( Site 1561)

La Jolla, California 92093-0698, United States

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

Los Angeles, California 90095, United States

University of California Davis Comprehensive Cancer Center ( Site 1560)

Sacramento, California 95817, United States

Stanford University Medical Center ( Site 1503)

Stanford, California 94305, United States

University of Colorado Cancer Center ( Site 1506)

Aurora, Colorado 80045, United States

Smilow Cancer Center at Yale-New Haven ( Site 1507)

New Haven, Connecticut 06510, United States

Boca Raton Regional Hospital ( Site 1551)

Boca Raton, Florida 33486, United States

UF Health ( Site 1511)

Gainesville, Florida 32608, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)

Miami, Florida 33136, United States

Winship Cancer Institute of Emory University ( Site 1512)

Atlanta, Georgia 30322-1013, United States

Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)

Indianapolis, Indiana 46202, United States

University of Iowa Hospital and Clinics ( Site 1514)

Iowa City, Iowa 52242, United States

University of Kentucky School of Medicine & Hospitals ( Site 1542)

Lexington, Kentucky 40536, United States

Massachusetts General Hospital ( Site 1518)

Boston, Massachusetts 02114, United States

Dana Farber Cancer Center ( Site 1519)

Boston, Massachusetts 02215, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)

Hackensack, New Jersey 07601, United States

Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565)

Lake Success, New York 11042, United States

Icahn School of Medicine at Mount Sinai ( Site 1575)

New York, New York 10029, United States

Cleveland Clinic ( Site 1541)

Cleveland, Ohio 44195, United States

Providence Portland Medical Center ( Site 1530)

Portland, Oregon 97213, United States

UPMC Hillman Cancer Center ( Site 1570)

Pittsburgh, Pennsylvania 15232, United States

MUSC Hollings Cancer Center ( Site 1533)

Charleston, South Carolina 29425, United States

West Cancer Center - East Campus ( Site 1535)

Germantown, Tennessee 38138, United States

Vanderbilt Ingram Cancer Center ( Site 1543)

Nashville, Tennessee 37232, United States

The University of Texas-MD Anderson Cancer Center ( Site 1536)

Houston, Texas 77030, United States

Huntsman Cancer Institute ( Site 1537)

Salt Lake City, Utah 84112, United States

Inova Schar Cancer Institute ( Site 1538)

Fairfax, Virginia 22031, United States

West Virginia University ( Site 1569)

Morgantown, West Virginia 26506, United States

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)

Ciudad Autónoma de Buenos Aires, Buenos Aires C1027AAP, Argentina

Centro Medico Privado CEMAIC ( Site 0024)

Capital, Córdoba Province X5008HHW, Argentina

Fundacion Estudios Clinicos-Oncology ( Site 0026)

Rosario, Santa Fe Province S2000DEJ, Argentina

Centro Oncológico de Rosario ( Site 0003)

Rosario, Santa Fe Province S2000KZE, Argentina

Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)

Buenos Aires, C1181ACH, Argentina

CEMIC ( Site 0012)

Buenos Aires, C1431FWO, Argentina

Fundacion CIDEA ( Site 0001)

CABA, C1121ABE, Argentina

Centro Oncologico Riojano Integral ( Site 0002)

La Rioja, F5300COE, Argentina

Centro Oncologico Norte ( Site 0023)

Santiago del Estero, G4200AWD, Argentina

Chris OBrien Lifehouse ( Site 0051)

Camperdown, New South Wales 2050, Australia

Lismore Base Hospital ( Site 0050)

Lismore, New South Wales 2480, Australia

Orange Health Services ( Site 0053)

Orange, New South Wales 2800, Australia

Royal North Shore Hospital ( Site 0052)

St Leonards, New South Wales 2065, Australia

Gold Coast University Hospital ( Site 0054)

Southport, Queensland 4215, Australia

Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)

Sunshine Coast, Queensland 4575, Australia

Alfred Health ( Site 0055)

Melbourne, Victoria 3004, Australia

Oncocentro Ceara ( Site 0108)

Fortaleza, Ceará 60135-237, Brazil

Hospital Erasto Gaertner ( Site 0101)

Curitiba, Paraná 81520-060, Brazil

Hospital Tacchini ( Site 0111)

Bento Gonçalves, Rio Grande do Sul 95700-084, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)

Ijuí, Rio Grande do Sul 98700000, Brazil

Hospital Bruno Born ( Site 0107)

Lajeado, Rio Grande do Sul 95900-000, Brazil

Hospital Sao Vicente de Paulo ( Site 0105)

Passo Fundo, Rio Grande do Sul 99010-080, Brazil

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)

Rio de Janeiro, 20220-410, Brazil

A. C. Camargo Cancer Center ( Site 0116)

São Paulo, 01509-010, Brazil

Tom Baker Cancer Center ( Site 0161)

Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute ( Site 0159)

Edmonton, Alberta T6G 1Z2, Canada

Juravinski Cancer Center ( Site 0151)

Hamilton, Ontario L8V 1C3, Canada

The Ottawa Hospital Cancer Centre ( Site 0154)

Ottawa, Ontario K1H 8L6, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)

Montreal, Quebec H1T 2M4, Canada

McGill University Health Centre ( Site 0162)

Montreal, Quebec H4A 3J1, Canada

James Lind Centro de Investigación del Cáncer ( Site 1653)

Temuco, Araucania 4800827, Chile

Enroll SpA ( Site 1654)

Santiago, Region M. de Santiago 7500587, Chile

Bradfordhill ( Site 1651)

Santiago, Region M. de Santiago 8420383, Chile

Bradford Hill Norte ( Site 1652)

Antofagasta, 1240000, Chile

Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)

Bogotá, Bogota D.C. 111411, Colombia

Instituto Nacional de Cancerologia E.S.E ( Site 0204)

Bogotá, Bogota D.C. 111511, Colombia

Oncomedica S.A. ( Site 0205)

Montería, Departamento de Córdoba 230002, Colombia

Oncologos del Occidente S.A. ( Site 0206)

Pereira, Risaralda Department 660001, Colombia

Fundación Cardiovascular de Colombia ( Site 0207)

Piedecuesta, Santander Department 68017, Colombia

Fundación Valle del Lili ( Site 0202)

Cali, Valle del Cauca Department 760032, Colombia

Hopital ARCHET 2 ( Site 0356)

Nice, Alpes-Maritimes 06200, France

Hopital Saint Joseph ( Site 0376)

Marseille, Bouches-du-Rhone 13285, France

Hopital La Timone ( Site 0353)

Marseille, Bouches-du-Rhone 13385, France

Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)

Caen, Calvados 14000, France

CHU Besancon - Hopital Jean Minjoz ( Site 0359)

Besançon, Doubs 25030, France

Centre Hospitalier de Valence ( Site 0377)

Valence, Drome 26953, France

C.H.U. de Nimes. Hopital Caremeau ( Site 0368)

Nîmes, Gard 30029, France

CHU de Bordeaux- Hopital Saint Andre ( Site 0370)

Bordeaux, Gironde 33075, France

Institut Claudius Regaud IUCT Oncopole ( Site 0354)

Toulouse, Haute-Garonne 31059, France

Centre Hospitalier Annecy Genevois ( Site 0361)

Pringy, Haute-Savoie 74374, France

CHU Montpellier. ( Site 0367)

Montpellier, Herault 34295, France

CHRU de Lille - Hopital Claude Huriez ( Site 0355)

Lille, Nord 59037, France

CHU Estaing ( Site 0360)

Clermont-Ferrand, Puy-de-Dome 63003, France

CH Lyon Sud Hospices Civils de Lyon ( Site 0350)

Pierre-Bénite, Rhone 69495, France

Hopital Avicenne ( Site 0358)

Bobigny, Seine-Saint-Denis 93009, France

Institut Gustave Roussy ( Site 0352)

Villejuif, Val-de-Marne 94800, France

CHU Poitiers ( Site 0375)

Poitiers, Vienne 86021, France

Universitaetsklinikum Tuebingen ( Site 0409)

Tübingen, Baden-Wurttemberg 72076, Germany

Klinikum Nürnberg Nord ( Site 0415)

Nuremberg, Bavaria 90419, Germany

Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)

Marburg, Hesse 35043, Germany

Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)

Buxtehude, Lower Saxony 21614, Germany

Medizinische Hochschule Hannover ( Site 0405)

Hanover, Lower Saxony 30625, Germany

Universitaetsklinikum Essen ( Site 0403)

Essen, North Rhine-Westphalia 45147, Germany

Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)

Berlin, 10117, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)

Hamburg, 20246, Germany

Andreas Syggros Hospital ( Site 0450)

Athens, Achaia 161 21, Greece

Attikon University General Hospital of Athens ( Site 0454)

Chaïdári, Attica 124 62, Greece

Metropolitan Hospital ( Site 0453)

Neo Faliro, Attica 185 47, Greece

Papageorgiou General Hospital ( Site 0451)

Thessaloniki, 564 03, Greece

European Interbalkan Medical Center ( Site 0455)

Thessaloniki, 570 01, Greece

Pecsi Tudomanyegyetem AOK ( Site 0501)

Pécs, Baranya 7632, Hungary

Szegedi Tudomanyegyetem ( Site 0504)

Szeged, Csongrád megye 6720, Hungary

Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)

Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary

Debreceni Egyetem. ( Site 0506)

Debrecen, Vas County 4032, Hungary

Semmelweis Egyetem ( Site 0507)

Budapest, 1083, Hungary

Szent Imre Egyetemi Oktatokorhaz ( Site 0502)

Budapest, 1115, Hungary

St. James s Hospital ( Site 1601)

Dublin, Dublin D08 K0Y5, Ireland

Soroka University Medical Center ( Site 0555)

Beersheba, 8410101, Israel

Rambam Health Care Campus-Oncology Division ( Site 0552)

Haifa, 3109601, Israel

Haddassah Medical Organization - Ein Kerem ( Site 0553)

Jerusalem, 9112001, Israel

Meir Medical Center ( Site 0556)

Kfar Saba, 4428132, Israel

Rabin Medical Center ( Site 0550)

Petah Tikva, 4941492, Israel

Chaim Sheba Medical Center ( Site 0551)

Ramat Gan, 5265601, Israel

Sourasky Medical Center ( Site 0554)

Tel Aviv, 6423906, Israel

Instituto Tumori Giovanni Paolo II ( Site 0604)

Bari, Apulia 70124, Italy

Azienda Ospedaliero Universitaria Pisana ( Site 0603)

Pisa, Tuscany 56126, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)

Milan, 20133, Italy

Istituto Europeo di Oncologia ( Site 0602)

Milan, 20141, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)

Naples, 80131, Italy

San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)

Tuxtla Gutiérrez, Chiapas 29090, Mexico

Cimab SA de CV ( Site 0708)

Torreón, Coahuila 27000, Mexico

Centro de Investigación Clínica de Alta Especialidad ( Site 0715)

Torreón, Coahuila 27010, Mexico

Onco-Hematologia de Occidente ( Site 0716)

Guadalajara, Jalisco 44260, Mexico

Hospital de Especialidades Centro Medico de Occidente ( Site 0704)

Guadalajara, Jalisco 44349, Mexico

Consultorios de Medicina Especializada del Sector Privado ( Site 0701)

Guadalajara, Jalisco 44680, Mexico

Centro de atencion e investigacion clinica en oncologia ( Site 0706)

Mérida, Yucatán 97134, Mexico

Centro Estatal de Cancerologia de Chihuahua ( Site 0703)

Chihuahua City, 31000, Mexico

FAICIC Clinical Research ( Site 0700)

Veracruz, 91900, Mexico

New Zealand Clinical Research (Auckland) ( Site 0800)

Auckland, 0624, New Zealand

Haukeland sykehus ( Site 0851)

Bergen, Hordaland 5021, Norway

St. Olavs Hospital HF ( Site 0852)

Trondheim, Sor-Trondelag 7030, Norway

Oslo Universitetssykehus Radiumhospitalet ( Site 0850)

Oslo, 0379, Norway

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)

Krakow, Lesser Poland Voivodeship 31-115, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)

Warsaw, Masovian Voivodeship 02-781, Poland

Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site

Gdansk, Pomeranian Voivodeship 80-214, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)

Gliwice, Silesian Voivodeship 44-101, Poland

Hospital Particular do Algarve ( Site 1005)

Faro, 8005-226, Portugal

Instituto Portugues de Oncologia de Lisboa ( Site 1003)

Lisbon, 1099-023, Portugal

Hospital CUF - Tejo ( Site 1004)

Lisbon, 1350-352, Portugal

CHLN Hospital Santa Maria ( Site 1001)

Lisbon, 1649-035, Portugal

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)

Porto, 4200-072, Portugal

S C Pelican Impex SRL ( Site 1108)

Oradea, Bihor County 410469, Romania

Hifu Terramed Conformal SRL ( Site 1111)

Bucharest, Bucharest 031864, Romania

Cardiomed SRL Cluj-Napoca ( Site 1104)

Cluj-Napoca, Cluj 400015, Romania

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)

Cluj-Napoca, Cluj 400015, Romania

Spitalul Universitar CF Cluj-Napoca ( Site 1103)

Cluj-Napoca, Cluj 400015, Romania

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)

Craiova, Dolj 200347, Romania

S C Oncocenter Oncologie Medicala S R L ( Site 1106)

Timișoara, Timiș County 300166, Romania

Policlinica Oncomed SRL ( Site 1105)

Timișoara, Timiș County 300239, Romania

S.C.Focus Lab Plus S.R.L ( Site 1107)

Bucharest, 022548, Romania

Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)

Bucharest, 030447, Romania

Altay Regional Oncology Dispensary ( Site 1168)

WBarnaularsaw, Altayskiy Kray 656045, Russia

GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)

Ufa, Baskortostan, Respublika 450054, Russia

A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological

Obninsk, Kaluzskaja Oblast 249036, Russia

Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)

Sochi, Krasnodarskiy Kray 354057, Russia

N.N. Blokhin NMRCO ( Site 1153)

Moscow, Moscow 115478, Russia

FSCC FMBA of Russia ( Site 1163)

Moscow, Moscow 115682, Russia

First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)

Moscow, Moscow 119991, Russia

Hadassah Medical-Oncology department ( Site 1173)

Moscow, Moscow Oblast 121205, Russia

Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)

Nizhny Novgorod, Nizhny Novgorod Oblast 603126, Russia

Railway Hospital of OJSC ( Site 1161)

Saint Petersburg, Sankt-Peterburg 195271, Russia

Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)

Izhevsk, Udmurtiya Republic 426009, Russia

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)

Yaroslavl, Yaroslavl Oblast 150054, Russia

Hospital Duran i Reynals ( Site 1254)

Hospitalet Del Llobregat, Barcelona 08908, Spain

Hospital Universitario Marques de Valdecilla ( Site 1256)

Santander, Cantabria 39008, Spain

Hospital Clinic i Provincial Barcelona ( Site 1253)

Barcelona, Catalonia 08036, Spain

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)

Doniostia - San Sebastian, Gipuzkoa 20014, Spain

Hospital General Universitari Vall d Hebron ( Site 1252)

Barcelona, 08035, Spain

Hospital Universitario Ramon y Cajal ( Site 1251)

Madrid, 28034, Spain

Hospital Universitario Carlos Haya ( Site 1255)

Málaga, 29010, Spain

Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine

Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)

Kharkiv, Kharkiv Oblast 61103, Ukraine

Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)

Kropyvnytskyi, Kirovohrad Oblast 25011, Ukraine

Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)

Sumy, Sumska Oblast 40022, Ukraine

Universal Clinic Oberig-Oncology Center ( Site 1461)

Kyiv, 03057, Ukraine

Royal Cornwall Hospitals NHS Trust ( Site 1402)

Truro, Cornwall TR1 3LQ, United Kingdom

University College Hospital London ( Site 1400)

London, London, City of NW1 2PG, United Kingdom

Guy s & St Thomas NHS Foundation Trust ( Site 1407)

London, London, City of SE1 9RT, United Kingdom

The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)

London, London, City of SW3 6JJ, United Kingdom

Royal Marsden NHS Foundation Trust ( Site 1408)

Sutton, London, City of SM2 5PT, United Kingdom

Churchill Hospital ( Site 1404)

Oxford, Oxfordshire OX3 7LE, United Kingdom