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NCT03833167

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2019-04-01

Completion Date

2026-01-20

Last Updated

2026-09-28

Healthy Volunteers

Conditions

Carcinoma, Squamous Cell

Interventions

BIOLOGICAL

Pembrolizumab

400 mg IV infusion

DRUG

Placebo

Placebo-matched IV infusion

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

Locations (181)

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

Mobile, Alabama, United States

City of Hope Medical Center ( Site 1505)

Duarte, California, United States

UCSD Moores Cancer Center ( Site 1561)

La Jolla, California, United States

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

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center ( Site 1560)

Sacramento, California, United States

Stanford University Medical Center ( Site 1503)

Stanford, California, United States

University of Colorado Cancer Center ( Site 1506)

Aurora, Colorado, United States

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

New Haven, Connecticut, United States

Boca Raton Regional Hospital ( Site 1551)

Boca Raton, Florida, United States

UF Health ( Site 1511)

Gainesville, Florida, United States

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

Miami, Florida, United States

Winship Cancer Institute of Emory University ( Site 1512)

Atlanta, Georgia, United States

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

Indianapolis, Indiana, United States

University of Iowa Hospital and Clinics ( Site 1514)

Iowa City, Iowa, United States

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

Lexington, Kentucky, United States

Massachusetts General Hospital ( Site 1518)

Boston, Massachusetts, United States

Dana Farber Cancer Center ( Site 1519)

Boston, Massachusetts, United States

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

Hackensack, New Jersey, United States

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

Lake Success, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 1575)

New York, New York, United States

Cleveland Clinic ( Site 1541)

Cleveland, Ohio, United States

Providence Portland Medical Center ( Site 1530)

Portland, Oregon, United States

UPMC Hillman Cancer Center ( Site 1570)

Pittsburgh, Pennsylvania, United States

MUSC Hollings Cancer Center ( Site 1533)

Charleston, South Carolina, United States

West Cancer Center - East Campus ( Site 1535)

Germantown, Tennessee, United States

Vanderbilt Ingram Cancer Center ( Site 1543)

Nashville, Tennessee, United States

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

Houston, Texas, United States

Huntsman Cancer Institute ( Site 1537)

Salt Lake City, Utah, United States

Inova Schar Cancer Institute ( Site 1538)

Fairfax, Virginia, United States

West Virginia University ( Site 1569)

Morgantown, West Virginia, United States

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

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Centro Medico Privado CEMAIC ( Site 0024)

Capital, Córdoba Province, Argentina

Fundacion Estudios Clinicos-Oncology ( Site 0026)

Rosario, Santa Fe Province, Argentina

Centro Oncológico de Rosario ( Site 0003)

Rosario, Santa Fe Province, Argentina

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

Buenos Aires, Argentina

CEMIC ( Site 0012)

Buenos Aires, Argentina

Fundacion CIDEA ( Site 0001)

CABA, Argentina

Centro Oncologico Riojano Integral ( Site 0002)

La Rioja, Argentina

Centro Oncologico Norte ( Site 0023)

Santiago del Estero, Argentina

Chris OBrien Lifehouse ( Site 0051)

Camperdown, New South Wales, Australia

Lismore Base Hospital ( Site 0050)

Lismore, New South Wales, Australia

Orange Health Services ( Site 0053)

Orange, New South Wales, Australia

Royal North Shore Hospital ( Site 0052)

St Leonards, New South Wales, Australia

Gold Coast University Hospital ( Site 0054)

Southport, Queensland, Australia

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

Sunshine Coast, Queensland, Australia

Alfred Health ( Site 0055)

Melbourne, Victoria, Australia

Oncocentro Ceara ( Site 0108)

Fortaleza, Ceará, Brazil

Hospital Erasto Gaertner ( Site 0101)

Curitiba, Paraná, Brazil

Hospital Tacchini ( Site 0111)

Bento Gonçalves, Rio Grande do Sul, Brazil

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

Ijuí, Rio Grande do Sul, Brazil

Hospital Bruno Born ( Site 0107)

Lajeado, Rio Grande do Sul, Brazil

Hospital Sao Vicente de Paulo ( Site 0105)

Passo Fundo, Rio Grande do Sul, Brazil

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

Rio de Janeiro, Brazil

A. C. Camargo Cancer Center ( Site 0116)

São Paulo, Brazil

Tom Baker Cancer Center ( Site 0161)

Calgary, Alberta, Canada

Cross Cancer Institute ( Site 0159)

Edmonton, Alberta, Canada

Juravinski Cancer Center ( Site 0151)

Hamilton, Ontario, Canada

The Ottawa Hospital Cancer Centre ( Site 0154)

Ottawa, Ontario, Canada

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

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0162)

Montreal, Quebec, Canada

James Lind Centro de Investigación del Cáncer ( Site 1653)

Temuco, Araucania, Chile

Enroll SpA ( Site 1654)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 1651)

Santiago, Region M. de Santiago, Chile

Bradford Hill Norte ( Site 1652)

Antofagasta, Chile

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

Bogotá, Bogota D.C., Colombia

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

Bogotá, Bogota D.C., Colombia

Oncomedica S.A. ( Site 0205)

Montería, Departamento de Córdoba, Colombia

Oncologos del Occidente S.A. ( Site 0206)

Pereira, Risaralda Department, Colombia

Fundación Cardiovascular de Colombia ( Site 0207)

Piedecuesta, Santander Department, Colombia

Fundación Valle del Lili ( Site 0202)

Cali, Valle del Cauca Department, Colombia

Hopital ARCHET 2 ( Site 0356)

Nice, Alpes-Maritimes, France

Hopital Saint Joseph ( Site 0376)

Marseille, Bouches-du-Rhone, France

Hopital La Timone ( Site 0353)

Marseille, Bouches-du-Rhone, France

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

Caen, Calvados, France

CHU Besancon - Hopital Jean Minjoz ( Site 0359)

Besançon, Doubs, France

Centre Hospitalier de Valence ( Site 0377)

Valence, Drome, France

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

Nîmes, Gard, France

CHU de Bordeaux- Hopital Saint Andre ( Site 0370)

Bordeaux, Gironde, France

Institut Claudius Regaud IUCT Oncopole ( Site 0354)

Toulouse, Haute-Garonne, France

Centre Hospitalier Annecy Genevois ( Site 0361)

Pringy, Haute-Savoie, France

CHU Montpellier. ( Site 0367)

Montpellier, Herault, France

CHRU de Lille - Hopital Claude Huriez ( Site 0355)

Lille, Nord, France

CHU Estaing ( Site 0360)

Clermont-Ferrand, Puy-de-Dome, France

CH Lyon Sud Hospices Civils de Lyon ( Site 0350)

Pierre-Bénite, Rhone, France

Hopital Avicenne ( Site 0358)

Bobigny, Seine-Saint-Denis, France

Institut Gustave Roussy ( Site 0352)

Villejuif, Val-de-Marne, France

CHU Poitiers ( Site 0375)

Poitiers, Vienne, France

Universitaetsklinikum Tuebingen ( Site 0409)

Tübingen, Baden-Wurttemberg, Germany

Klinikum Nürnberg Nord ( Site 0415)

Nuremberg, Bavaria, Germany

Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)

Marburg, Hesse, Germany

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

Buxtehude, Lower Saxony, Germany

Medizinische Hochschule Hannover ( Site 0405)

Hanover, Lower Saxony, Germany

Universitaetsklinikum Essen ( Site 0403)

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)

Hamburg, Germany

Andreas Syggros Hospital ( Site 0450)

Athens, Achaia, Greece

Attikon University General Hospital of Athens ( Site 0454)

Chaïdári, Attica, Greece

Metropolitan Hospital ( Site 0453)

Neo Faliro, Attica, Greece

Papageorgiou General Hospital ( Site 0451)

Thessaloniki, Greece

European Interbalkan Medical Center ( Site 0455)