To comprehensively describe the molecular profile of the tumour ecosystem of cutaneous squamous cell carcinoma (CSCC) patients treated with neoadjuvant immunotherapy using single-cell sequencing and bulk genomic profiling.
The purpose of this study is to comprehensively assess the molecular profile of the tumour ecosystem of CSCC patients who receive immunotherapy in the neoadjuvant curative setting, in order to identify molecular mechanisms facilitating treatment response and resistance and to identify molecular markers for disease monitoring. Patients who receive immunotherapy for the neoadjuvant management of CSCC will be invited to participate in this translational research study during their treatment journey to provide tumour tissue (fresh and formal-fixed paraffin-embedded, FFPE) and blood samples before and after exposure to immunotherapy. This study has primarily a translational research objective with the clinical component conducted as a prospective, single-centre, single-arm, open label study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
11
Cemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials.
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Rate of successful execution and generation of data from single-cell RNA sequencing and genomic profiling (including whole exome sequencing, RNA sequencing and immunohistochemistry) of CSCC from patients treated with immunotherapy
Generation of analyzable data from single-cell RNA sequencing and genomic profiling
Time frame: At 72 months
To evaluate pathological response rates (cPR, mPR defined as <10% viable tumour, and other).
Time frame: Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by RECIST 1.1
Time frame: Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by imRECIST
Time frame: Estimated 48 months
To summarise immune-related adverse events (AE) > grade 2, AESI, AEs > grade 3 and SAEs, according to CTCAE v5.0.
Time frame: At 72 months
To evaluate DFS rates.
Time frame: Estimated 48 months
To evaluate OS rates.
Time frame: Estimated 48 months
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