Skin Cancer Clinical Study (18 yrs+)

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

Study Description

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells.
The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.

The study is looking at:
The side effects of cemiplimab might cause
how well cemiplimab works

Brief Summary

The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.

Condition or Disease

Cutaneous Squamous Cell Carcinoma

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	369
Primary Outcome Measures	Event-Free Survival (EFS) as assessed by the investigator
Actual Study Start Date:	January 2025
Estimated Primary Completion Date:	May 2030

Eligibility Criteria

Ages Eligible for Study:	18 and older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Cutaneous Squamous Cell Carcinoma

Inclusion Criteria

Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol
Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
Adequate hepatic, renal and bone marrow functions, as described in the protocol

Exclusion Criteria

Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, basal cell carcinoma, basosquamous.carcinoma, Bowen’s disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for Immune-mediated Adverse Events (imAEs), as described in the protocol
History of non-infectious pneumonitis within the last 5 years
TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa

ADDITIONAL DETAILS

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Cutaneous Squamous Cell Carcinoma Study (18 Years+)