Abstract 2716
Background
CSCC is the second most common skin cancer. While the surgical cure rate for CSCC is > 95%, a proportion of pts are considered to have high-risk for recurrence as assessed by immune status, primary disease stage, extent of nodal involvement, presence of extracapsular extension, and prior treatment. Post-operative RT is recommended for pts with high-risk features, but relapse with locoregional recurrence or distant metastases may still occur. This study evaluates the efficacy of cemiplimab, a human anti–PD-1 monoclonal antibody, as an adjuvant therapy for pts with CSCC with high-risk features, after surgery and RT.
Trial design
This randomised, placebo-controlled, double-blind, multicentre, Phase III study will evaluate cemiplimab as an adjuvant treatment for pts with high-risk CSCC, based on surgical and clinicopathologic findings, who have completed surgery and post-operative RT. Immunocompromised pts were excluded. The trial will enrol 412 pts from about 100 sites in North America, Europe, and Asia-Pacific regions. Pts with at least one of the following high-risk features are eligible: a) nodal disease with extracapsular extension b) in-transit metastases c) T4 lesion d) perineural invasion and e) recurrent CSCC with at least one other risk factor. In Part 1 (blinded), pts will be randomised 1:1 to receive 350 mg cemiplimab or placebo intravenously every 3 weeks (Q3W) for up to 48 weeks. In optional Part 2 (unblinded), pts in the placebo arm who experience disease recurrence or pts in the cemiplimab arm who experience disease recurrence ≥3 months after completion of 48-week treatment in Part 1 will be eligible to receive open-label 350 mg Q3W cemiplimab for up to 96 weeks. Key objectives are to compare disease-free survival (primary) as well as overall survival, freedom from locoregional relapse, and distant relapse (secondary) of adjuvant cemiplimab vs placebo in pts with high-risk CSCC.
Clinical trial identification
Editorial acknowledgement
Medical writing support and typesetting was provided by Bu Reinen of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc., and Sanofi.
Funding
Regeneron Pharmaceuticals, Inc., and Sanofi.
Disclosure
D. Rischin: Research grant / Funding (institution), Non-remunerated activity/ies: Regeneron Pharmaceuticals, Inc.; Research grant / Funding (institution), Non-remunerated activity/ies: GSK; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Merck; Research grant / Funding (institution), Non-remunerated activity/ies: Bristol-Myers Squibb; Research grant / Funding (institution): Roche. M.G. Fury: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. I. Lowy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. E. Stankevich: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. S. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. H. Han: Full / Part-time employment: Regeneron Pharmaceuticals, Inc. S.V. Porceddu: Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Serono; Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Sharp & Dohme; Advisory / Consultancy: UpToDate; Advisory / Consultancy: Oral Oncology.
Resources from the same session
5520 - Patient’s Usability Test results of a CINV Diary Application For Smartphones
Presenter: Paz Fernandez
Session: Poster Display session 3
Resources:
Abstract
2323 - Colorectal Telephone Assessment Pathway (CTAP) - A viable means of shortening time to a definitive diagnosis of Colorectal Cancer (CRC)
Presenter: Harriet Watson
Session: Poster Display session 3
Resources:
Abstract
6119 - Cancer Nursing and Social Media: Capturing the Zeitgeist
Presenter: Mark Foulkes
Session: Poster Display session 3
Resources:
Abstract
1776 - Examination of mobile applications on breast cancer
Presenter: AYDANUR AYDIN
Session: Poster Display session 3
Resources:
Abstract
4128 - E-health effectiveness to increase patient adherence for immunotherapy; a cost-benefit study.
Presenter: Maria José Dias
Session: Poster Display session 3
Resources:
Abstract
3219 - Experiences of internet-based stepped care among individuals with recently diagnosed cancer and symptoms of anxiety and/or depression
Presenter: Anna Hauffman
Session: Poster Display session 3
Resources:
Abstract
5010 - What do cancer patients know about their immunotherapy treatment?
Presenter: Mónica Arellano
Session: Poster Display session 3
Resources:
Abstract
4503 - Prospective Comparison of Travel Burden, Cost and Time to Obtain Tumor Board Treatment Plan Through In-Person Visits vs. an AI Enabled Health Technology (N=1803)
Presenter: Rajendra Badwe
Session: Poster Display session 3
Resources:
Abstract
4123 - Cancer care through the fire and flames: 3-year experience in the utilisation of electronic consultation and referral system at the Red Zone in Southern Thailand
Presenter: Nanthiya Rattanakhot
Session: Poster Display session 3
Resources:
Abstract
2087 - The effect of e-mobile education on the quality of life in women with breast cancer
Presenter: Derya ÇInar
Session: Poster Display session 3
Resources:
Abstract