Deep sequencIng in Cutaneous Squamous CEll caRciNomas

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT05878288
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials.

Study Details

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.

Key Dates

Start date
May 26, 2023
Status verified
Nov 2024
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Cemiplimab
    Cemiplimab 350 mg intravenously every 3 weeks for up to 12 weeks (up to 4 doses), or until unacceptable toxicity, disease progression, or withdrawal of consent.

Primary Outcome Measure

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 [ Time Frame: At 72 months ]

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