Tests cemiplimab injected into early skin squamous cell carcinoma against surgery
Compares an injected immune drug with surgery in adults with early skin cancer.
Plain-language title generated from the registry record
Registry title: Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Key facts
- Where
- Darlinghurst, Fremantle, South Yarra, Westmead, and Woolloongabba, AustraliaSee the 5 sites
- Phase
- Phase 3
Where in Australia
- The Skin HospitalDarlinghurst, AustraliaTaking people
- Fremantle DermatologyFremantle, AustraliaTaking people
- Dermatology Institute of Victoria (DIV)South Yarra, AustraliaTaking people
- Westmead HospitalWestmead, AustraliaTaking people
- Princess Alexandra HospitalWoolloongabba, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT06585410
- Record updated
- 16 September 2026
- Original 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.Read full original descriptionShow less
A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
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 compared to surgery
Inclusion: 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) prior to biopsy and >0.7 cm to ≤2.0 cm after biopsy, 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: 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; 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; Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid 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.); History of non-infectious pneumonitis within the last 5 years.