Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
About this study
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
- Condition
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Tested
- Cemiplimab, Standard of care
- Sponsor
- Regeneron Pharmaceuticals
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Cutaneous Squamous Cell Carcinoma (CSCC)
- 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 6
- 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.)
- 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.
Where
53 sites, 50 recruiting
The Skin Hospital
Darlinghurst, New South Wales, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Dermatology Institute of Victoria (DIV)
South Yarra, Victoria, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
University of New Mexico
Albuquerque, New Mexico, United States
and 47 more sites on ClinicalTrials.gov
Contact
-
Clinical Trials Administrator
844-734-6643 clinicaltrials@regeneron.com
Potential match only. Final eligibility is determined by the study team.