Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

April 15, 2024 updated by: Merck Sharp & Dohme LLC

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)
      • Buenos Aires, Argentina, C1431FWO
        • CEMIC ( Site 0012)
      • Caba, Argentina, C1121ABE
        • Fundacion CIDEA ( Site 0001)
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral ( Site 0002)
      • Santiago del Estero, Argentina, G4200AWD
        • Centro Oncologico Norte ( Site 0023)
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)
    • Cordoba
      • Capital, Cordoba, Argentina, X5008HHW
        • Centro Medico Privado CEMAIC ( Site 0024)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Fundacion Estudios Clinicos-Oncology ( Site 0026)
      • Rosario, Santa Fe, Argentina, S2000KZE
        • Centro Oncológico de Rosario ( Site 0003)
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse ( Site 0051)
      • Lismore, New South Wales, Australia, 2480
        • Lismore Base Hospital ( Site 0050)
      • Orange, New South Wales, Australia, 2800
        • Orange Health Services ( Site 0053)
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital ( Site 0052)
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast University Hospital ( Site 0054)
      • Sunshine Coast, Queensland, Australia, 4575
        • Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health ( Site 0055)
  • Brazil
      • Rio de Janeiro, Brazil, 20220-410
        • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)
      • Sao Paulo, Brazil, 01509-010
        • A. C. Camargo Cancer Center ( Site 0116)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60135-237
        • Oncocentro Ceara ( Site 0108)
    • Parana
      • Curitiba, Parana, Brazil, 81520-060
        • Hospital Erasto Gaertner ( Site 0101)
    • Rio Grande Do Sul
      • Bento Goncalves, Rio Grande Do Sul, Brazil, 95700-084
        • Hospital Tacchini ( Site 0111)
      • Ijui, Rio Grande Do Sul, Brazil, 98700000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)
      • Lajeado, Rio Grande Do Sul, Brazil, 95900-000
        • Hospital Bruno Born ( Site 0107)
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
        • Hospital Sao Vicente de Paulo ( Site 0105)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center ( Site 0161)
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ( Site 0159)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Center ( Site 0151)
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre ( Site 0154)
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0162)
  • Chile
      • Antofagasta, Chile, 1240000
        • Bradford Hill Norte ( Site 1652)
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • James Lind Centro de Investigación del Cáncer ( Site 1653)
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500587
        • Enroll SpA ( Site 1654)
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Bradfordhill ( Site 1651)
  • Colombia
    • Cordoba
      • Monteria, Cordoba, Colombia, 230002
        • Oncomedica S.A. ( Site 0205)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111411
        • Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)
      • Bogota, Distrito Capital De Bogota, Colombia, 111511
        • Instituto Nacional de Cancerologia E.S.E ( Site 0204)
    • Risaralda
      • Pereira, Risaralda, Colombia, 660001
        • Oncologos del Occidente S.A. ( Site 0206)
    • Santander
      • Piedecuesta, Santander, Colombia, 68017
        • Fundación Cardiovascular de Colombia ( Site 0207)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundación Valle del Lili ( Site 0202)
  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Hopital ARCHET 2 ( Site 0356)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13285
        • Hopital Saint Joseph ( Site 0376)
      • Marseille, Bouches-du-Rhone, France, 13385
        • Hopital La Timone ( Site 0353)
    • Calvados
      • Caen, Calvados, France, 14000
        • Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU Besancon - Hopital Jean Minjoz ( Site 0359)
    • Drome
      • Valence, Drome, France, 26953
        • Centre Hospitalier de Valence ( Site 0377)
    • Gard
      • Nimes, Gard, France, 30029
        • C.H.U. de Nimes. Hopital Caremeau ( Site 0368)
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • CHU de Bordeaux- Hopital Saint Andre ( Site 0370)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Institut Claudius Regaud IUCT Oncopole ( Site 0354)
    • Haute-Savoie
      • Pringy, Haute-Savoie, France, 74374
        • Centre Hospitalier Annecy Genevois ( Site 0361)
    • Herault
      • Montpellier, Herault, France, 34295
        • CHU Montpellier. ( Site 0367)
    • Nord
      • Lille, Nord, France, 59037
        • CHRU de Lille - Hopital Claude Huriez ( Site 0355)
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • CHU Estaing ( Site 0360)
    • Rhone
      • Pierre Benite, Rhone, France, 69495
        • CH Lyon Sud Hospices Civils de Lyon ( Site 0350)
    • Seine-Saint-Denis
      • Bobigny, Seine-Saint-Denis, France, 93009
        • Hopital Avicenne ( Site 0358)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Institut Gustave Roussy ( Site 0352)
    • Vienne
      • Poitiers, Vienne, France, 86021
        • CHU Poitiers ( Site 0375)
  • Germany
      • Berlin, Germany, 10117
        • Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)
    • Baden-Wurttemberg
      • Tuebingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen ( Site 0409)
    • Bayern
      • Nürnberg, Bayern, Germany, 90419
        • Klinikum Nürnberg Nord ( Site 0415)
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)
    • Niedersachsen
      • Buxtehude, Niedersachsen, Germany, 21614
        • Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0405)
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Universitaetsklinikum Essen ( Site 0403)
  • Greece
      • Thessaloniki, Greece, 564 03
        • Papageorgiou General Hospital ( Site 0451)
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center ( Site 0455)
    • Achaia
      • Athens, Achaia, Greece, 161 21
        • Andreas Syggros Hospital ( Site 0450)
    • Attiki
      • Chaidari, Attiki, Greece, 124 62
        • Attikon University General Hospital of Athens ( Site 0454)
      • Neo Faliro, Attiki, Greece, 185 47
        • Metropolitan Hospital ( Site 0453)
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem ( Site 0507)
      • Budapest, Hungary, 1115
        • Szent Imre Egyetemi Oktatokorhaz ( Site 0502)
    • Baranya
      • Pecs, Baranya, Hungary, 7632
        • Pecsi Tudomanyegyetem AOK ( Site 0501)
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Szegedi Tudomanyegyetem ( Site 0504)
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)
    • Vas
      • Debrecen, Vas, Hungary, 4032
        • Debreceni Egyetem. ( Site 0506)
  • Ireland
    • Dublin
      • Dublin 8, Dublin, Ireland, D08 K0Y5
        • St. James s Hospital ( Site 1601)
  • Israel
      • Beer Sheva, Israel, 8410101
        • Soroka University Medical Center ( Site 0555)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology Division ( Site 0552)
      • Jerusalem, Israel, 9112001
        • Haddassah Medical Organization - Ein Kerem ( Site 0553)
      • Kfar-Saba, Israel, 4428132
        • Meir Medical Center ( Site 0556)
      • Petah Tiqwa, Israel, 4941492
        • Rabin Medical Center ( Site 0550)
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center ( Site 0551)
      • Tel-Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 0554)
  • Italy
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia ( Site 0602)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Instituto Tumori Giovanni Paolo II ( Site 0604)
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana ( Site 0603)
  • Mexico
      • Chihuahua, Mexico, 31000
        • Centro Estatal de Cancerologia de Chihuahua ( Site 0703)
      • Veracruz, Mexico, 91900
        • FAICIC Clinical Research ( Site 0700)
    • Chiapas
      • Tuxtla Gutierrez, Chiapas, Mexico, 29090
        • San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Cimab SA de CV ( Site 0708)
      • Torreón, Coahuila, Mexico, 27010
        • Centro de Investigación Clínica de Alta Especialidad ( Site 0715)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44260
        • Onco-Hematologia de Occidente ( Site 0716)
      • Guadalajara, Jalisco, Mexico, 44349
        • Hospital de Especialidades Centro Medico de Occidente ( Site 0704)
      • Guadalajara, Jalisco, Mexico, 44680
        • Consultorios de Medicina Especializada del Sector Privado ( Site 0701)
    • Yucatan
      • Merida, Yucatan, Mexico, 97134
        • Centro de atencion e investigacion clinica en oncologia ( Site 0706)
  • New Zealand
      • Auckland, New Zealand, 0624
        • New Zealand Clinical Research (Auckland) ( Site 0800)
  • Norway
      • Oslo, Norway, 0379
        • Oslo Universitetssykehus Radiumhospitalet ( Site 0850)
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland sykehus ( Site 0851)
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Norway, 7030
        • St. Olavs Hospital HF ( Site 0852)
  • Poland
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-115
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-101
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)
  • Portugal
      • Faro, Portugal, 8005-226
        • Hospital Particular do Algarve ( Site 1005)
      • Lisboa, Portugal, 1099-023
        • Instituto Portugues de Oncologia de Lisboa ( Site 1003)
      • Lisboa, Portugal, 1350-352
        • Hospital CUF - Tejo ( Site 1004)
      • Lisboa, Portugal, 1649-035
        • CHLN Hospital Santa Maria ( Site 1001)
      • Porto, Portugal, 4200-072
        • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)
  • Romania
      • Bucuresti, Romania, 022548
        • S.C.Focus Lab Plus S.R.L ( Site 1107)
      • Bucuresti, Romania, 030447
        • Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • S C Pelican Impex SRL ( Site 1108)
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 031864
        • Hifu Terramed Conformal SRL ( Site 1111)
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Cardiomed SRL Cluj-Napoca ( Site 1104)
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)
      • Cluj-Napoca, Cluj, Romania, 400015
        • Spitalul Universitar CF Cluj-Napoca ( Site 1103)
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)
    • Timis
      • Timisoara, Timis, Romania, 300166
        • S C Oncocenter Oncologie Medicala S R L ( Site 1106)
      • Timisoara, Timis, Romania, 300239
        • Policlinica Oncomed SRL ( Site 1105)
  • Russian Federation
    • Altayskiy Kray
      • WBarnaularsaw, Altayskiy Kray, Russian Federation, 656045
        • Altay Regional Oncology Dispensary ( Site 1168)
    • Baskortostan, Respublika
      • Ufa, Baskortostan, Respublika, Russian Federation, 450054
        • GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)
    • Kaluzskaja Oblast
      • Obninsk, Kaluzskaja Oblast, Russian Federation, 249036
        • A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
    • Krasnodarskiy Kray
      • Sochi, Krasnodarskiy Kray, Russian Federation, 354057
        • Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)
    • Moskovskaya Oblast
      • Moscow, Moskovskaya Oblast, Russian Federation, 121205
        • Hadassah Medical-Oncology department ( Site 1173)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • N.N. Blokhin NMRCO ( Site 1153)
      • Moscow, Moskva, Russian Federation, 115682
        • FSCC FMBA of Russia ( Site 1163)
      • Moscow, Moskva, Russian Federation, 119991
        • First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)
    • Nizhegorodskaya Oblast
      • Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603126
        • Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195271
        • Railway Hospital of OJSC ( Site 1161)
    • Udmurtskaya Respublika
      • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426009
        • Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)
    • Yaroslavskaya Oblast
      • Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150054
        • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d Hebron ( Site 1252)
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal ( Site 1251)
      • Malaga, Spain, 29010
        • Hospital Universitario Carlos Haya ( Site 1255)
    • Barcelona
      • Hospitalet del Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals ( Site 1254)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla ( Site 1256)
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Hospital Clinic i Provincial Barcelona ( Site 1253)
    • Gipuzkoa
      • Doniostia - San Sebastian, Gipuzkoa, Spain, 20014
        • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Universal Clinic Oberig-Oncology Center ( Site 1461)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61103
        • Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)
    • Kirovohradska Oblast
      • Kropyvnytskyi, Kirovohradska Oblast, Ukraine, 25011
        • Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)
    • Sumska Oblast
      • Sumy, Sumska Oblast, Ukraine, 40022
        • Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)
  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospitals NHS Trust ( Site 1402)
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • University College Hospital London ( Site 1400)
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy s & St Thomas NHS Foundation Trust ( Site 1407)
      • London, London, City Of, United Kingdom, SW3 6JJ
        • The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)
      • Sutton, London, City Of, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust ( Site 1408)
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Churchill Hospital ( Site 1404)
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama, Mitchell Cancer Institute ( Site 1562)
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center ( Site 1505)
      • La Jolla, California, United States, 92093-0698
        • UCSD Moores Cancer Center ( Site 1561)
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center ( Site 1560)
      • Stanford, California, United States, 94305
        • Stanford University Medical Center ( Site 1503)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center ( Site 1506)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Center at Yale-New Haven ( Site 1507)
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital ( Site 1551)
      • Gainesville, Florida, United States, 32608
        • UF Health ( Site 1511)
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Winship Cancer Institute of Emory University ( Site 1512)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics ( Site 1514)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky School of Medicine & Hospitals ( Site 1542)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 1518)
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Center ( Site 1519)
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565)
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 1575)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic ( Site 1541)
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center ( Site 1530)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center ( Site 1570)
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Hollings Cancer Center ( Site 1533)
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center - East Campus ( Site 1535)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Ingram Cancer Center ( Site 1543)
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas-MD Anderson Cancer Center ( Site 1536)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute ( Site 1537)
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute ( Site 1538)
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University ( Site 1569)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab
Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.
Biological: Pembrolizumab 400 mg
Administered by IV infusion on Day 1 of each 42-day cycle
Other Names:
  • MK-3475
  • KEYTRUDA®
Placebo Comparator: Placebo
Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Drug: Placebo
Administered by IV infusion on Day 1 of each 42-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
Time Frame: Up to approximately 60 months
RFS was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first.
Up to approximately 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 60 months
OS is the time from randomization to death due to any cause.
Up to approximately 60 months
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time Frame: Baseline and up to approximately 60 months
Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.
Baseline and up to approximately 60 months
Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score
Time Frame: Baseline and up to approximately 60 months
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.
Baseline and up to approximately 60 months
Percentage of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 63 months
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE will be presented.
Up to approximately 63 months
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to approximately 38 months
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE will be presented.
Up to approximately 38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Estimated)

May 5, 2025

Study Completion (Estimated)

September 29, 2028

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-630
  • MK-3475-630 (Other Identifier: Merck)
  • KEYNOTE-630 (Other Identifier: Merck)
  • 2018-001974-76 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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