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Cemiplimab

Phase 2

Cutaneous Squamous Cell Carcinoma | Small molecule | Oncology |Sanofi|Last Updated: Nov 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05878288Deep sequencIng in Cutaneous Squamous CEll caRciNomasPHASE2 ACTIVE NOT_RECRUITING 11 — — May 26, 2023May 1, 2029Nov 21, 20241 Australia
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Study Endpoints
Primary Endpoints
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
At 72 months

Generation of analyzable data from single-cell RNA sequencing and genomic profiling

Secondary Endpoints
To evaluate pathological response rates (cPR, mPR defined as <10% viable tumour, and other).
Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by RECIST 1.1
Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by imRECIST
Estimated 48 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
CemiplimabOTHERCemiplimab 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.
Interventions
NameTypeDescription
CemiplimabDRUGCemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Stage II to IV (M0) CSCC who are candidates for surgery, but who have an increased risk of recurrence and/or risk of disfigurement or loss of function. Patients with stage III or IV (M0) CSCC of the head/neck, extremity, or trunk are eligible, and patients with stage II CSCC ...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05878288primaryCompletionDate: changed
LOWMay 24, 2026NCT05878288studyFirstPostDate: changed