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Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Trial Status: active
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 cemiplimab might cause
- How well cemiplimab works
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 Key
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 NOTE: Other protocol defined inclusion / exclusion criteria apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06585410.