Carcinoma, Squamous CellPhase 3NCT03833167
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
A Phase 3 study testing Pembrolizumab in people with Carcinoma, Squamous Cell, run by Merck Sharp & Dohme LLC at 181 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 181 sitesin 24 countries
- Study dates
- 1 Apr 2019to 20 Jan 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
181 sites in 24 countries.
181 sites in 24 countries
United States30 sites
Winship Cancer Institute of Emory University ( Site 1512)
Atlanta, Georgia, 30322-1013
University of Colorado Cancer Center ( Site 1506)
Aurora, Colorado, 80045
Boca Raton Regional Hospital ( Site 1551)
Boca Raton, Florida, 33486
Massachusetts General Hospital ( Site 1518)
Boston, Massachusetts, 02114
Dana Farber Cancer Center ( Site 1519)
Boston, Massachusetts, 02215
MUSC Hollings Cancer Center ( Site 1533)
Charleston, South Carolina, 29425
Cleveland Clinic ( Site 1541)
Cleveland, Ohio, 44195
City of Hope Medical Center ( Site 1505)
Duarte, California, 91010
Inova Schar Cancer Institute ( Site 1538)
Fairfax, Virginia, 22031
UF Health ( Site 1511)
Gainesville, Florida, 32608
West Cancer Center - East Campus ( Site 1535)
Germantown, Tennessee, 38138
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)
Hackensack, New Jersey, 07601
The University of Texas-MD Anderson Cancer Center ( Site 1536)
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)
Indianapolis, Indiana, 46202
University of Iowa Hospital and Clinics ( Site 1514)
Iowa City, Iowa, 52242
UCSD Moores Cancer Center ( Site 1561)
La Jolla, California, 92093-0698
Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565)
Lake Success, New York, 11042
University of Kentucky School of Medicine & Hospitals ( Site 1542)
Lexington, Kentucky, 40536
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
Los Angeles, California, 90095
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)
Miami, Florida, 33136
University of South Alabama, Mitchell Cancer Institute ( Site 1562)
Mobile, Alabama, 36604
West Virginia University ( Site 1569)
Morgantown, West Virginia, 26506
Vanderbilt Ingram Cancer Center ( Site 1543)
Nashville, Tennessee, 37232
Smilow Cancer Center at Yale-New Haven ( Site 1507)
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai ( Site 1575)
New York, New York, 10029
UPMC Hillman Cancer Center ( Site 1570)
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center ( Site 1530)
Portland, Oregon, 97213
University of California Davis Comprehensive Cancer Center ( Site 1560)
Sacramento, California, 95817
Huntsman Cancer Institute ( Site 1537)
Salt Lake City, Utah, 84112
Stanford University Medical Center ( Site 1503)
Stanford, California, 94305
France17 sites
CHU Besancon - Hopital Jean Minjoz ( Site 0359)
Besançon, Doubs, 25030
Hopital Avicenne ( Site 0358)
Bobigny, Seine-Saint-Denis, 93009
CHU de Bordeaux- Hopital Saint Andre ( Site 0370)
Bordeaux, Gironde, 33075
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)
Caen, Calvados, 14000
CHU Estaing ( Site 0360)
Clermont-Ferrand, Puy-de-Dome, 63003
CHRU de Lille - Hopital Claude Huriez ( Site 0355)
Lille, Nord, 59037
Hopital Saint Joseph ( Site 0376)
Marseille, Bouches-du-Rhone, 13285
Hopital La Timone ( Site 0353)
Marseille, Bouches-du-Rhone, 13385
CHU Montpellier. ( Site 0367)
Montpellier, Herault, 34295
Hopital ARCHET 2 ( Site 0356)
Nice, Alpes-Maritimes, 06200
C.H.U. de Nimes. Hopital Caremeau ( Site 0368)
Nîmes, Gard, 30029
CH Lyon Sud Hospices Civils de Lyon ( Site 0350)
Pierre-Bénite, Rhone, 69495
CHU Poitiers ( Site 0375)
Poitiers, Vienne, 86021
Centre Hospitalier Annecy Genevois ( Site 0361)
Pringy, Haute-Savoie, 74374
Institut Claudius Regaud IUCT Oncopole ( Site 0354)
Toulouse, Haute-Garonne, 31059
Centre Hospitalier de Valence ( Site 0377)
Valence, Drome, 26953
Institut Gustave Roussy ( Site 0352)
Villejuif, Val-de-Marne, 94800
Russia12 sites
Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)
Izhevsk, Udmurtiya Republic, 426009
N.N. Blokhin NMRCO ( Site 1153)
Moscow, Moscow, 115478
FSCC FMBA of Russia ( Site 1163)
Moscow, Moscow, 115682
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)
Moscow, Moscow, 119991
Hadassah Medical-Oncology department ( Site 1173)
Moscow, Moscow Oblast, 121205
Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
Obninsk, Kaluzskaja Oblast, 249036
Railway Hospital of OJSC ( Site 1161)
Saint Petersburg, Sankt-Peterburg, 195271
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)
Sochi, Krasnodarskiy Kray, 354057
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)
Ufa, Baskortostan, Respublika, 450054
Altay Regional Oncology Dispensary ( Site 1168)
WBarnaularsaw, Altayskiy Kray, 656045
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)
Yaroslavl, Yaroslavl Oblast, 150054
Romania10 sites
Hifu Terramed Conformal SRL ( Site 1111)
Bucharest, Bucharest, 031864
S.C.Focus Lab Plus S.R.L ( Site 1107)
Bucharest, 022548
Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)
Bucharest, 030447
Cardiomed SRL Cluj-Napoca ( Site 1104)
Cluj-Napoca, Cluj, 400015
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)
Cluj-Napoca, Cluj, 400015
Spitalul Universitar CF Cluj-Napoca ( Site 1103)
Cluj-Napoca, Cluj, 400015
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)
Craiova, Dolj, 200347
S C Pelican Impex SRL ( Site 1108)
Oradea, Bihor County, 410469
S C Oncocenter Oncologie Medicala S R L ( Site 1106)
Timișoara, Timiș County, 300166
Policlinica Oncomed SRL ( Site 1105)
Timișoara, Timiș County, 300239
Argentina9 sites
Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)
Buenos Aires, C1181ACH
CEMIC ( Site 0012)
Buenos Aires, C1431FWO
Fundacion CIDEA ( Site 0001)
CABA, C1121ABE
Centro Medico Privado CEMAIC ( Site 0024)
Capital, Córdoba Province, X5008HHW
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1027AAP
Centro Oncologico Riojano Integral ( Site 0002)
La Rioja, F5300COE
Fundacion Estudios Clinicos-Oncology ( Site 0026)
Rosario, Santa Fe Province, S2000DEJ
Centro Oncológico de Rosario ( Site 0003)
Rosario, Santa Fe Province, S2000KZE
Centro Oncologico Norte ( Site 0023)
Santiago del Estero, G4200AWD
Mexico9 sites
Centro Estatal de Cancerologia de Chihuahua ( Site 0703)
Chihuahua City, 31000
Onco-Hematologia de Occidente ( Site 0716)
Guadalajara, Jalisco, 44260
Hospital de Especialidades Centro Medico de Occidente ( Site 0704)
Guadalajara, Jalisco, 44349
Consultorios de Medicina Especializada del Sector Privado ( Site 0701)
Guadalajara, Jalisco, 44680
Centro de atencion e investigacion clinica en oncologia ( Site 0706)
Mérida, Yucatán, 97134
Cimab SA de CV ( Site 0708)
Torreón, Coahuila, 27000
Centro de Investigación Clínica de Alta Especialidad ( Site 0715)
Torreón, Coahuila, 27010
San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)
Tuxtla Gutiérrez, Chiapas, 29090
FAICIC Clinical Research ( Site 0700)
Veracruz, 91900
Brazil8 sites
Hospital Tacchini ( Site 0111)
Bento Gonçalves, Rio Grande do Sul, 95700-084
Hospital Erasto Gaertner ( Site 0101)
Curitiba, Paraná, 81520-060
Oncocentro Ceara ( Site 0108)
Fortaleza, Ceará, 60135-237
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)
Ijuí, Rio Grande do Sul, 98700000
Hospital Bruno Born ( Site 0107)
Lajeado, Rio Grande do Sul, 95900-000
Hospital Sao Vicente de Paulo ( Site 0105)
Passo Fundo, Rio Grande do Sul, 99010-080
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)
Rio de Janeiro, 20220-410
A. C. Camargo Cancer Center ( Site 0116)
São Paulo, 01509-010
Germany8 sites
Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)
Berlin, 10117
Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)
Buxtehude, Lower Saxony, 21614
Universitaetsklinikum Essen ( Site 0403)
Essen, North Rhine-Westphalia, 45147
Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)
Hamburg, 20246
Medizinische Hochschule Hannover ( Site 0405)
Hanover, Lower Saxony, 30625
Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)
Marburg, Hesse, 35043
Klinikum Nürnberg Nord ( Site 0415)
Nuremberg, Bavaria, 90419
Universitaetsklinikum Tuebingen ( Site 0409)
Tübingen, Baden-Wurttemberg, 72076
Australia7 sites
Chris OBrien Lifehouse ( Site 0051)
Camperdown, New South Wales, 2050
Lismore Base Hospital ( Site 0050)
Lismore, New South Wales, 2480
Alfred Health ( Site 0055)
Melbourne, Victoria, 3004
Orange Health Services ( Site 0053)
Orange, New South Wales, 2800
Gold Coast University Hospital ( Site 0054)
Southport, Queensland, 4215
Royal North Shore Hospital ( Site 0052)
St Leonards, New South Wales, 2065
Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)
Sunshine Coast, Queensland, 4575
Israel7 sites
Soroka University Medical Center ( Site 0555)
Beersheba, 8410101
Rambam Health Care Campus-Oncology Division ( Site 0552)
Haifa, 3109601
Haddassah Medical Organization - Ein Kerem ( Site 0553)
Jerusalem, 9112001
Meir Medical Center ( Site 0556)
Kfar Saba, 4428132
Rabin Medical Center ( Site 0550)
Petah Tikva, 4941492
Chaim Sheba Medical Center ( Site 0551)
Ramat Gan, 5265601
Sourasky Medical Center ( Site 0554)
Tel Aviv, 6423906
Spain7 sites
Hospital Clinic i Provincial Barcelona ( Site 1253)
Barcelona, Catalonia, 08036
Hospital General Universitari Vall d Hebron ( Site 1252)
Barcelona, 08035
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)
Doniostia - San Sebastian, Gipuzkoa, 20014
Hospital Duran i Reynals ( Site 1254)
Hospitalet Del Llobregat, Barcelona, 08908
Hospital Universitario Ramon y Cajal ( Site 1251)
Madrid, 28034
Hospital Universitario Carlos Haya ( Site 1255)
Málaga, 29010
Hospital Universitario Marques de Valdecilla ( Site 1256)
Santander, Cantabria, 39008
Canada6 sites
Tom Baker Cancer Center ( Site 0161)
Calgary, Alberta, T2N 4N2
Cross Cancer Institute ( Site 0159)
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Center ( Site 0151)
Hamilton, Ontario, L8V 1C3
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)
Montreal, Quebec, H1T 2M4
McGill University Health Centre ( Site 0162)
Montreal, Quebec, H4A 3J1
The Ottawa Hospital Cancer Centre ( Site 0154)
Ottawa, Ontario, K1H 8L6
Colombia6 sites
Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)
Bogotá, Bogota D.C., 111411
Instituto Nacional de Cancerologia E.S.E ( Site 0204)
Bogotá, Bogota D.C., 111511
Fundación Valle del Lili ( Site 0202)
Cali, Valle del Cauca Department, 760032
Oncomedica S.A. ( Site 0205)
Montería, Departamento de Córdoba, 230002
Oncologos del Occidente S.A. ( Site 0206)
Pereira, Risaralda Department, 660001
Fundación Cardiovascular de Colombia ( Site 0207)
Piedecuesta, Santander Department, 68017
Hungary6 sites
Semmelweis Egyetem ( Site 0507)
Budapest, 1083
Szent Imre Egyetemi Oktatokorhaz ( Site 0502)
Budapest, 1115
Debreceni Egyetem. ( Site 0506)
Debrecen, Vas County, 4032
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
Pecsi Tudomanyegyetem AOK ( Site 0501)
Pécs, Baranya, 7632
Szegedi Tudomanyegyetem ( Site 0504)
Szeged, Csongrád megye, 6720
United Kingdom6 sites
University College Hospital London ( Site 1400)
London, London, City of, NW1 2PG
Guy s & St Thomas NHS Foundation Trust ( Site 1407)
London, London, City of, SE1 9RT
The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)
London, London, City of, SW3 6JJ
Churchill Hospital ( Site 1404)
Oxford, Oxfordshire, OX3 7LE
Royal Marsden NHS Foundation Trust ( Site 1408)
Sutton, London, City of, SM2 5PT
Royal Cornwall Hospitals NHS Trust ( Site 1402)
Truro, Cornwall, TR1 3LQ
Greece5 sites
Andreas Syggros Hospital ( Site 0450)
Athens, Achaia, 161 21
Attikon University General Hospital of Athens ( Site 0454)
Chaïdári, Attica, 124 62
Metropolitan Hospital ( Site 0453)
Neo Faliro, Attica, 185 47
Papageorgiou General Hospital ( Site 0451)
Thessaloniki, 564 03
European Interbalkan Medical Center ( Site 0455)
Thessaloniki, 570 01
Italy5 sites
Instituto Tumori Giovanni Paolo II ( Site 0604)
Bari, Apulia, 70124
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)
Milan, 20133
Istituto Europeo di Oncologia ( Site 0602)
Milan, 20141
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)
Naples, 80131
Azienda Ospedaliero Universitaria Pisana ( Site 0603)
Pisa, Tuscany, 56126
Portugal5 sites
Hospital Particular do Algarve ( Site 1005)
Faro, 8005-226
Instituto Portugues de Oncologia de Lisboa ( Site 1003)
Lisbon, 1099-023
Hospital CUF - Tejo ( Site 1004)
Lisbon, 1350-352
CHLN Hospital Santa Maria ( Site 1001)
Lisbon, 1649-035
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)
Porto, 4200-072
Ukraine5 sites
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)
Kharkiv, Kharkiv Oblast, 61103
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)
Kropyvnytskyi, Kirovohrad Oblast, 25011
Universal Clinic Oberig-Oncology Center ( Site 1461)
Kyiv, 03057
Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)
Sumy, Sumska Oblast, 40022
Chile4 sites
Bradford Hill Norte ( Site 1652)
Antofagasta, 1240000
Enroll SpA ( Site 1654)
Santiago, Region M. de Santiago, 7500587
Bradfordhill ( Site 1651)
Santiago, Region M. de Santiago, 8420383
James Lind Centro de Investigación del Cáncer ( Site 1653)
Temuco, Araucania, 4800827
Poland4 sites
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
Gdansk, Pomeranian Voivodeship, 80-214
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)
Gliwice, Silesian Voivodeship, 44-101
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)
Krakow, Lesser Poland Voivodeship, 31-115
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)
Warsaw, Masovian Voivodeship, 02-781
Norway3 sites
Haukeland sykehus ( Site 0851)
Bergen, Hordaland, 5021
Oslo Universitetssykehus Radiumhospitalet ( Site 0850)
Oslo, 0379
St. Olavs Hospital HF ( Site 0852)
Trondheim, Sor-Trondelag, 7030
New Zealand1 site
New Zealand Clinical Research (Auckland) ( Site 0800)
Auckland, 0624
About this study
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)
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).
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Pembrolizumab, Placebo
- Keywords
- Programmed Cell Death-1 (PD-1), Programmed Cell Death 1, PD1, Programmed Cell Death Ligand 1 (PD-L1), Programmed Cell Death Ligand 2 (PD-L2), PDL1, PDL2
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called KEYTRUDA®, MK-3475
400 mg IV infusion
PlaceboDrug
Placebo-matched IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | 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. Receives: Biological: Pembrolizumab |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
RFS as assessed by investigator 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. Participants were analyzed in the treatment group to which they were randomized. RFS as assessed by investigator is presented.
Measured: Up to approximately 62 months
Secondary outcomes (5)
Overall Survival (OS)
OS is the time from randomization to death due to any cause. Participants were analyzed in the treatment group to which they were randomized. OS is presented.
Measured: Up to approximately 62 months
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.
Measured: 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
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. Participants were analyzed in the treatment group to which they were randomized. Change from baseline in EORTC QLQ-C30 physical functioning is presented.
Measured: Baseline and up to approximately 60 months
Percentage of Participants Who Experience an Adverse Event (AE)
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 is presented.
Measured: Up to approximately 62 months
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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 is presented.
Measured: Up to approximately 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Apr 2019
- Primary completion28 Jun 2024
- Study completion20 Jan 2026
Why it stopped: The study stopped due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833167
- Sponsor's protocol ID
- 3475-630
- Other IDs
- MK-3475-630, KEYNOTE-630, 2022-500395-57-00, U1111-1275-8212, 2018-001974-76, 2018
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2019
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf