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  • R2810-ONC-1788

    Acronym: 

    R2810-ONC-1788

    ACTRN/NCT /ethics: 

    NCT03969004

    Scientific title: 

    Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

    Summary of trial and patient characteristics

    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase All phases Tumour Stream Squamous Cell Carcinoma
    Age Range 18 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2019-06-04
    Molecular Target Anticipated End Date 2026-02-11
    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase All phases
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Squamous Cell Carcinoma
    Cancer Stage All stages
    Anticipated Start Date 2019-06-04
    Anticipated End Date 2026-02-11

    Trial Summary

    The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: - To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT.

    Lay Summary

    Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

    Sponsor / Cooperative group

    Regeneron

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Recruiting
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Not Yet Recruiting