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

NCT03833167 | Completed Phase 3 Results DMC FDA Drug

• 6 other identifiers: 3475-630MK-3475-630KEYNOTE-6302022-500395-57-00U1111-1275-82122018-001974-76
• Study Type: interventional
• Target: 450
• Locations: 24 countries
• Sites: 181

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).

Conditions

Carcinoma, Squamous Cell

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 62 months

Secondary Outcomes (5)

• Overall Survival (OS)

  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

  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

  Baseline and up to approximately 60 months

• Percentage of Participants Who Experience an Adverse Event (AE)

  Up to approximately 62 months

• Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

  Up to approximately 19 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Pembrolizumab BIOLOGICAL

400 mg IV infusion

Also known as: KEYTRUDA®, MK-3475

Pembrolizumab

Placebo DRUG

Placebo-matched IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (181)

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

Mobile, Alabama, 36604, United States

Location

City of Hope Medical Center ( Site 1505)

Duarte, California, 91010, United States

Location

UCSD Moores Cancer Center ( Site 1561)

La Jolla, California, 92093-0698, United States

Location

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

Los Angeles, California, 90095, United States

Location

University of California Davis Comprehensive Cancer Center ( Site 1560)

Sacramento, California, 95817, United States

Location

Stanford University Medical Center ( Site 1503)

Stanford, California, 94305, United States

Location

University of Colorado Cancer Center ( Site 1506)

Aurora, Colorado, 80045, United States

Location

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

New Haven, Connecticut, 06510, United States

Location

Boca Raton Regional Hospital ( Site 1551)

Boca Raton, Florida, 33486, United States

Location

UF Health ( Site 1511)

Gainesville, Florida, 32608, United States

Location

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

Miami, Florida, 33136, United States

Location

Winship Cancer Institute of Emory University ( Site 1512)

Atlanta, Georgia, 30322-1013, United States

Location

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

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospital and Clinics ( Site 1514)

Iowa City, Iowa, 52242, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital ( Site 1518)

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Center ( Site 1519)

Boston, Massachusetts, 02215, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

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

Lake Success, New York, 11042, United States

Location

Icahn School of Medicine at Mount Sinai ( Site 1575)

New York, New York, 10029, United States

Location

Cleveland Clinic ( Site 1541)

Cleveland, Ohio, 44195, United States

Location

Providence Portland Medical Center ( Site 1530)

Portland, Oregon, 97213, United States

Location

UPMC Hillman Cancer Center ( Site 1570)

Pittsburgh, Pennsylvania, 15232, United States

Location

MUSC Hollings Cancer Center ( Site 1533)

Charleston, South Carolina, 29425, United States

Location

West Cancer Center - East Campus ( Site 1535)

Germantown, Tennessee, 38138, United States

Location

Vanderbilt Ingram Cancer Center ( Site 1543)

Nashville, Tennessee, 37232, United States

Location

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

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute ( Site 1537)

Salt Lake City, Utah, 84112, United States

Location

Inova Schar Cancer Institute ( Site 1538)

Fairfax, Virginia, 22031, United States

Location

West Virginia University ( Site 1569)

Morgantown, West Virginia, 26506, United States

Location

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

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1027AAP, Argentina

Location

Centro Medico Privado CEMAIC ( Site 0024)

Capital, Córdoba Province, X5008HHW, Argentina

Location

Fundacion Estudios Clinicos-Oncology ( Site 0026)

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Centro Oncológico de Rosario ( Site 0003)

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

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

Buenos Aires, C1181ACH, Argentina

Location

CEMIC ( Site 0012)

Buenos Aires, C1431FWO, Argentina

Location

Fundacion CIDEA ( Site 0001)

CABA, C1121ABE, Argentina

Location

Centro Oncologico Riojano Integral ( Site 0002)

La Rioja, F5300COE, Argentina

Location

Centro Oncologico Norte ( Site 0023)

Santiago del Estero, G4200AWD, Argentina

Location

Chris OBrien Lifehouse ( Site 0051)

Camperdown, New South Wales, 2050, Australia

Location

Lismore Base Hospital ( Site 0050)

Lismore, New South Wales, 2480, Australia

Location

Orange Health Services ( Site 0053)

Orange, New South Wales, 2800, Australia

Location

Royal North Shore Hospital ( Site 0052)

St Leonards, New South Wales, 2065, Australia

Location

Gold Coast University Hospital ( Site 0054)

Southport, Queensland, 4215, Australia

Location

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

Sunshine Coast, Queensland, 4575, Australia

Location

Alfred Health ( Site 0055)

Melbourne, Victoria, 3004, Australia

Location

Oncocentro Ceara ( Site 0108)

Fortaleza, Ceará, 60135-237, Brazil

Location

Hospital Erasto Gaertner ( Site 0101)

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital Tacchini ( Site 0111)

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

Location

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

Ijuí, Rio Grande do Sul, 98700000, Brazil

Location

Hospital Bruno Born ( Site 0107)

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Hospital Sao Vicente de Paulo ( Site 0105)

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

Location

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

Rio de Janeiro, 20220-410, Brazil

Location

A. C. Camargo Cancer Center ( Site 0116)

São Paulo, 01509-010, Brazil

Location

Tom Baker Cancer Center ( Site 0161)

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute ( Site 0159)

Edmonton, Alberta, T6G 1Z2, Canada

Location

Juravinski Cancer Center ( Site 0151)

Hamilton, Ontario, L8V 1C3, Canada

Location

The Ottawa Hospital Cancer Centre ( Site 0154)

Ottawa, Ontario, K1H 8L6, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Health Centre ( Site 0162)

Montreal, Quebec, H4A 3J1, Canada

Location

Enroll SpA ( Site 1654)

Santiago, Region M. de Santiago, 7500587, Chile

Location

Bradfordhill ( Site 1651)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigación del Cáncer ( Site 1653)

Temuco, Región de la Araucanía, 4800827, Chile

Location

Bradford Hill Norte ( Site 1652)

Antofagasta, 1240000, Chile

Location

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

Bogotá, Bogota D.C., 111411, Colombia

Location

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

Bogotá, Bogota D.C., 111511, Colombia

Location

Oncomedica S.A. ( Site 0205)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Oncologos del Occidente S.A. ( Site 0206)

Pereira, Risaralda Department, 660001, Colombia

Location

Fundación Cardiovascular de Colombia ( Site 0207)

Piedecuesta, Santander Department, 68017, Colombia

Location

Fundación Valle del Lili ( Site 0202)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Hopital ARCHET 2 ( Site 0356)

Nice, Alpes-Maritimes, 06200, France

Location

Hopital Saint Joseph ( Site 0376)

Marseille, Bouches-du-Rhone, 13285, France

Location

Hopital La Timone ( Site 0353)

Marseille, Bouches-du-Rhone, 13385, France

Location

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

Caen, Calvados, 14000, France

Location

CHU Besancon - Hopital Jean Minjoz ( Site 0359)

Besançon, Doubs, 25030, France

Location

Centre Hospitalier de Valence ( Site 0377)

Valence, Drome, 26953, France

Location

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

Nîmes, Gard, 30029, France

Location

CHU de Bordeaux- Hopital Saint Andre ( Site 0370)

Bordeaux, Gironde, 33075, France

Location

Institut Claudius Regaud IUCT Oncopole ( Site 0354)

Toulouse, Haute-Garonne, 31059, France

Location

Centre Hospitalier Annecy Genevois ( Site 0361)

Pringy, Haute-Savoie, 74374, France

Location

CHU Montpellier. ( Site 0367)

Montpellier, Herault, 34295, France

Location

CHRU de Lille - Hopital Claude Huriez ( Site 0355)

Lille, Nord, 59037, France

Location

CHU Estaing ( Site 0360)

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

Location

CH Lyon Sud Hospices Civils de Lyon ( Site 0350)

Pierre-Bénite, Rhone, 69495, France

Location

Hopital Avicenne ( Site 0358)

Bobigny, Seine-Saint-Denis, 93009, France

Location

Institut Gustave Roussy ( Site 0352)

Villejuif, Val-de-Marne, 94800, France

Location

CHU Poitiers ( Site 0375)

Poitiers, Vienne, 86021, France

Location

Universitaetsklinikum Tuebingen ( Site 0409)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum Nürnberg Nord ( Site 0415)

Nuremberg, Bavaria, 90419, Germany

Location

Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)

Marburg, Hesse, 35043, Germany

Location

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

Buxtehude, Lower Saxony, 21614, Germany

Location

Medizinische Hochschule Hannover ( Site 0405)

Hanover, Lower Saxony, 30625, Germany

Location

Universitaetsklinikum Essen ( Site 0403)

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)

Berlin, 10117, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)

Hamburg, 20246, Germany

Location

Andreas Syggros Hospital ( Site 0450)

Athens, Achaia, 161 21, Greece

Location

Attikon University General Hospital of Athens ( Site 0454)

Chaïdári, Attica, 124 62, Greece

Location

Metropolitan Hospital ( Site 0453)

Neo Faliro, Attica, 185 47, Greece

Location

Papageorgiou General Hospital ( Site 0451)

Thessaloniki, 564 03, Greece

Location

European Interbalkan Medical Center ( Site 0455)

Thessaloniki, 570 01, Greece

Location

Pecsi Tudomanyegyetem AOK ( Site 0501)

Pécs, Baranya, 7632, Hungary

Location

Szegedi Tudomanyegyetem ( Site 0504)

Szeged, Csongrád megye, 6720, Hungary

Location

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

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Debreceni Egyetem. ( Site 0506)

Debrecen, Vas County, 4032, Hungary

Location

Semmelweis Egyetem ( Site 0507)

Budapest, 1083, Hungary

Location

Szent Imre Egyetemi Oktatokorhaz ( Site 0502)

Budapest, 1115, Hungary

Location

St. James s Hospital ( Site 1601)

Dublin, Dublin, D08 K0Y5, Ireland

Location

Soroka University Medical Center ( Site 0555)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus-Oncology Division ( Site 0552)

Haifa, 3109601, Israel

Location

Haddassah Medical Organization - Ein Kerem ( Site 0553)

Jerusalem, 9112001, Israel

Location

Meir Medical Center ( Site 0556)

Kfar Saba, 4428132, Israel

Location

Rabin Medical Center ( Site 0550)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 0551)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 0554)

Tel Aviv, 6423906, Israel

Location

Instituto Tumori Giovanni Paolo II ( Site 0604)

Bari, Apulia, 70124, Italy

Location

Azienda Ospedaliero Universitaria Pisana ( Site 0603)

Pisa, Tuscany, 56126, Italy

Location

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

Milan, 20133, Italy

Location

Istituto Europeo di Oncologia ( Site 0602)

Milan, 20141, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)

Naples, 80131, Italy

Location

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

Tuxtla Gutiérrez, Chiapas, 29090, Mexico

Location

Cimab SA de CV ( Site 0708)

Torreón, Coahuila, 27000, Mexico

Location

Centro de Investigación Clínica de Alta Especialidad ( Site 0715)

Torreón, Coahuila, 27010, Mexico

Location

Onco-Hematologia de Occidente ( Site 0716)

Guadalajara, Jalisco, 44260, Mexico

Location

Hospital de Especialidades Centro Medico de Occidente ( Site 0704)

Guadalajara, Jalisco, 44349, Mexico

Location

Consultorios de Medicina Especializada del Sector Privado ( Site 0701)

Guadalajara, Jalisco, 44680, Mexico

Location

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

Mérida, Yucatán, 97134, Mexico

Location

Centro Estatal de Cancerologia de Chihuahua ( Site 0703)

Chihuahua City, 31000, Mexico

Location

FAICIC Clinical Research ( Site 0700)

Veracruz, 91900, Mexico

Location

New Zealand Clinical Research (Auckland) ( Site 0800)

Auckland, 0624, New Zealand

Location

Haukeland sykehus ( Site 0851)

Bergen, Hordaland, 5021, Norway

Location

St. Olavs Hospital HF ( Site 0852)

Trondheim, Sor-Trondelag, 7030, Norway

Location

Oslo Universitetssykehus Radiumhospitalet ( Site 0850)

Oslo, 0379, Norway

Location

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

Krakow, Lesser Poland Voivodeship, 31-115, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)

Gliwice, Silesian Voivodeship, 44-101, Poland

Location

Hospital Particular do Algarve ( Site 1005)

Faro, 8005-226, Portugal

Location

Instituto Portugues de Oncologia de Lisboa ( Site 1003)

Lisbon, 1099-023, Portugal

Location

Hospital CUF - Tejo ( Site 1004)

Lisbon, 1350-352, Portugal

Location

CHLN Hospital Santa Maria ( Site 1001)

Lisbon, 1649-035, Portugal

Location

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

Porto, 4200-072, Portugal

Location

S C Pelican Impex SRL ( Site 1108)

Oradea, Bihor County, 410469, Romania

Location

Hifu Terramed Conformal SRL ( Site 1111)

Bucharest, București, 031864, Romania

Location

Cardiomed SRL Cluj-Napoca ( Site 1104)

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Cluj-Napoca, Cluj, 400015, Romania

Location

Spitalul Universitar CF Cluj-Napoca ( Site 1103)

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Craiova, Dolj, 200347, Romania

Location

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

Timișoara, Timiș County, 300166, Romania

Location

Policlinica Oncomed SRL ( Site 1105)

Timișoara, Timiș County, 300239, Romania

Location

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

Bucharest, 022548, Romania

Location

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

Bucharest, 030447, Romania

Location

Altay Regional Oncology Dispensary ( Site 1168)

WBarnaularsaw, Altayskiy Kray, 656045, Russia

Location

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

Ufa, Baskortostan, Respublika, 450054, Russia

Location

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

Obninsk, Kaluzskaja Oblast, 249036, Russia

Location

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

Sochi, Krasnodarskiy Kray, 354057, Russia

Location

N.N. Blokhin NMRCO ( Site 1153)

Moscow, Moscow, 115478, Russia

Location

FSCC FMBA of Russia ( Site 1163)

Moscow, Moscow, 115682, Russia

Location

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

Moscow, Moscow, 119991, Russia

Location

Hadassah Medical-Oncology department ( Site 1173)

Moscow, Moscow Oblast, 121205, Russia

Location

Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia

Location

Railway Hospital of OJSC ( Site 1161)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)

Izhevsk, Udmurtiya Republic, 426009, Russia

Location

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

Hospital Duran i Reynals ( Site 1254)

Hospitalet Del Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marques de Valdecilla ( Site 1256)

Santander, Cantabria, 39008, Spain

Location

Hospital Clinic i Provincial Barcelona ( Site 1253)

Barcelona, Catalonia, 08036, Spain

Location

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)

Doniostia - San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital General Universitari Vall d Hebron ( Site 1252)

Barcelona, 08035, Spain

Location

Hospital Universitario Ramon y Cajal ( Site 1251)

Madrid, 28034, Spain

Location

Hospital Universitario Carlos Haya ( Site 1255)

Málaga, 29010, Spain

Location

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61103, Ukraine

Location

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

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

Location

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

Sumy, Sumska Oblast, 40022, Ukraine

Location

Universal Clinic Oberig-Oncology Center ( Site 1461)

Kyiv, 03057, Ukraine

Location

Royal Cornwall Hospitals NHS Trust ( Site 1402)

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

University College Hospital London ( Site 1400)

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

Location

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

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

Location

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

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

Location

Royal Marsden NHS Foundation Trust ( Site 1408)

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

Location

Churchill Hospital ( Site 1404)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Links

• Merck Clinical Trial Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: April 1, 2019
• Primary Completion: June 28, 2024
• Study Completion: January 20, 2026
• Last Updated: March 10, 2026
• Results First Posted: July 22, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (8); BR (8); IE (1); UA (5); IL (7); CL (4); AU (7); GB (6); CA (6); PL (4); PT (5); RO (10); ES (7); RU (12); NZ (1); AR (9); US (30); HU (6); ME (9); GR (5); CO (6); FR (17); IT (5); NO (3)