Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)
NCT ID: NCT03284424
Last Updated: 2024-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2017-10-26
2023-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R/M cSCC cohort
Participants with R/M cSCC receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Pembrolizumab
IV infusion
LA cSCC cohort
Participants with LA cSCC receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Pembrolizumab
IV infusion
Interventions
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Pembrolizumab
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has cSCC that is either metastatic defined as disseminated disease, and/or unresectable disease that is not curable by surgery or radiation.
* Has histologically-confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
* LA cSCC cohort only:
* Must be ineligible for surgical resection.
* Participants who received prior radiation therapy (RT) to index site or must be deemed to be not eligible for RT.
* Participants who received prior systemic therapy for curative intent are eligible regardless of regimen.
* R/M cSCC cohort only:
* Has metastatic disease defined as disseminated disease distant to the initial/primary site of diagnosis, and/or must have locally recurrent disease that has been previously treated (with either surgery or radiotherapy), and is not amenable to either curative surgery or radiotherapy.
* Has measurable disease based on RECIST 1.1 as assessed by the central imaging vendor.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of study treatment.
* Has adequate organ function.
* Has a tissue sample adequate for programmed death-ligand 1 (PD-L1) testing as determined by central laboratory testing prior to study allocation.
* Has a life expectancy \>3 months.
* Female participants of childbearing potential must agree to use an adequate method of contraception during the study treatment period and for at least 120 days after the last dose of study treatment.
Exclusion Criteria
* Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study, e.g. basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), melanoma.
* Has had any prior allogeneic solid organ or bone marrow transplantation.
* Has received prior therapy with an anti-programmed death protein-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 \[CTLA-4\], Tumor necrosis factor receptor superfamily, member 4 \[OX-40\], tumor necrosis factor receptor superfamily member 9 \[CD137\]).
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study allocation.
(Notes: Participants must have recovered from all AEs due to previously administered therapies to ≤ Grade 1 or baseline. If a participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.)
* Has received prior radiotherapy within 2 weeks of start of study treatment.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g. with use of disease-modifying agents, anticoagulants, corticosteroids or immunosuppressive drugs).
* Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of Hepatitis B or known active Hepatitis C virus 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 treatment.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Moores UC San Diego Cancer Center ( Site 0352)
La Jolla, California, United States
Stanford University Medical Center ( Site 0366)
Palo Alto, California, United States
St. Joseph Heritage Healthcare ( Site 0350)
Santa Rosa, California, United States
Yale University ( Site 0365)
New Haven, Connecticut, United States
Lombardi Comprehensive Cancer Center ( Site 0360)
Washington D.C., District of Columbia, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)
Indianapolis, Indiana, United States
University of Kansas Cancer Center ( Site 0361)
Westwood, Kansas, United States
Massachusetts General Hospital ( Site 0362)
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada ( Site 8001)
Las Vegas, Nevada, United States
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)
Hackensack, New Jersey, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0364)
Tulsa, Oklahoma, United States
Fox Chase Cancer Center ( Site 0351)
Philadelphia, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 0356)
Sioux Falls, South Dakota, United States
Texas Oncology PA ( Site 8000)
Dallas, Texas, United States
Orange Health Services ( Site 0406)
Orange, New South Wales, Australia
Southern Medical Day Care Centre ( Site 0408)
Wollongong, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 0407)
Herston, Queensland, Australia
Princess Alexandra Hospital ( Site 0405)
Woolloongabba, Queensland, Australia
The Townsville Hospital ( Site 0404)
Douglas, , Australia
Lismore Base Hospital ( Site 0402)
Lismore, , Australia
Dr. Leon Richard Oncology Centre ( Site 0100)
Moncton, New Brunswick, Canada
The Ottawa Hospital Cancer Centre ( Site 0101)
Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0105)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario, Canada
Jewish General Hospital ( Site 0103)
Montreal, Quebec, Canada
IUCT - Oncopole ( Site 0604)
Toulouse, Cedex 9, France
Hopital Avicenne ( Site 0609)
Bobigny, , France
CHRU Lille - Hopital Claude Huriez ( Site 0605)
Lille, , France
CHU Limoges CHU Dupuytren ( Site 0608)
Limoges, , France
Hopital La Timone ( Site 0603)
Marseille, , France
Hopital Archet 3 ( Site 0607)
Nice, , France
Hopital Saint-Louis ( Site 0601)
Paris, , France
CH Lyon Sud Hospices Civils de Lyon ( Site 0600)
Pierre-Bénite, , France
CHU Reims - Hopital Robert Debre ( Site 0610)
Reims, , France
Institut Gustave Roussy (IGR) ( Site 0602)
Villejuif, , France
Universitaetsklinikum Essen ( Site 0650)
Essen, , Germany
Medizinische Hochschule Hannover ( Site 0652)
Hanover, , Germany
Universitaets-Hautklinik Kiel ( Site 0656)
Kiel, , Germany
Universitaetsklinikum Mannheim GmbH ( Site 0654)
Mannheim, , Germany
Universitatsklinikum Tübingen ( Site 0651)
Tübingen, , Germany
Rambam Health Care Campus ( Site 0950)
Haifa, , Israel
Rabin Medical Center ( Site 0952)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0953)
Ramat Gan, , Israel
Sourasky Medical Center. ( Site 0951)
Tel Aviv, , Israel
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)
Guadalajara, Jalisco, Mexico
Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)
Monterrey, Nuevo León, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0308)
Chihuahua City, , Mexico
Grupo Medico Camino SC ( Site 0300)
Mexico City, , Mexico
Haukeland Universitetssykehus ( Site 0902)
Bergen, , Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 0901)
Oslo, , Norway
Hospital Duran i Reinals ICO de Hospitalet ( Site 0751)
Hospitalet Del Llobregat, Barcelona, Spain
Hospital Vall D Hebron ( Site 0750)
Barcelona, , Spain
Hospital Clinic i Provincial Barcelona ( Site 0754)
Barcelona, , Spain
Hospital Universitario Ramon y Cajal ( Site 0753)
Madrid, , Spain
Hospital General de Valencia ( Site 0752)
Valencia, , Spain
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)
Bebington, Wirral, United Kingdom
University College Hospital NHS Foundation Trust ( Site 0801)
London, , United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0800)
London, , United Kingdom
Royal Cornwall Hospitals NHS Trust ( Site 0804)
Truro, , United Kingdom
Countries
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References
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Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Zhang P, Gumuscu B, Swaby RF, Hughes BGM. Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629). J Clin Oncol. 2020 Sep 1;38(25):2916-2925. doi: 10.1200/JCO.19.03054. Epub 2020 Jul 16.
Bratland A, Munoz-Couselo E, Mortier L, Roshdy O, Gonzalez R, Schachter J, Arance AM, Grange F, Meyer N, Joshi AJ, Billan S, Hughes BGM, Grob JJ, Ramakrishnan K, Ge J, Gumuscu B, Swaby RF, Gutzmer R. Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629. Dermatol Ther (Heidelb). 2023 Dec;13(12):3165-3180. doi: 10.1007/s13555-023-01059-y. Epub 2023 Nov 9.
Hughes BGM, Mendoza RG, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Chirovsky D, Zhang P, Gumuscu B, Swaby RF, Grob JJ. Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629. Dermatol Ther (Heidelb). 2021 Oct;11(5):1777-1790. doi: 10.1007/s13555-021-00598-6. Epub 2021 Sep 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trial Information
Other Identifiers
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MK-3475-629
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-629
Identifier Type: OTHER
Identifier Source: secondary_id
2017-000594-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-629
Identifier Type: -
Identifier Source: org_study_id
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