NCT05878288

Deep sequencIng in Cutaneous Squamous CEll caRciNomas

Comprehensive and Deep Profiling in Cutaneous Squamous Cell Carcinomas to Unravel Treatment Efficacy in Immunotherapy Treated Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cutaneous Squamous Cell Carcinoma
• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Neoplasms
• Non-melanoma Skin Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials.

Timeline

• Start date: 2023-05-26
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2023-05-26
• Last updated: 2024-11-21

Locations

1 site across 1 country: Australia