Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Key Inclusion Criteria:

1. Participants who have a histologically confirmed invasive CSCC TL, as described inthe protocol

2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) located in eitherthe Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol

3. Participants who are judged to be eligible for surgical resection of their CSCC TLand the method of planned surgical resection would be Micrographically orientedhistographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margincontrol are not eligible

4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1

5. Adequate hepatic, renal and bone marrow functions, as described in the protocol

Key Exclusion Criteria:

1. Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma,desmoplastic carcinoma, basal cell carcinoma, basosquamous.carcinoma, Bowen'sdisease, or CSCC in situ without an invasive component. (Note: For participants withinvasive CSCC with a minor basaloid component, the patient may be eligible afterdiscussion with the sponsor medical director.)

2. Ongoing or recent (within 5 years) evidence of significant autoimmune disease thatrequired treatment with systemic immunosuppressive treatments, which may suggestrisk for Immune-mediated Adverse Events (imAEs), as described in the protocol

3. History of non-infectious pneumonitis within the last 5 years

4. TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dryred lip (vermillion), oral cavity, or nasal mucosa

NOTE: Other protocol defined inclusion / exclusion criteria apply.