Clinical trial NCT06585410: Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Official title: A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)
Keywords: Dermato-Oncology
Cemiplimab
Early Stage
Skin Cancer
Non-Melanoma Skin Cancer
UV Skin Damage
Chronic Sun Exposure
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Key Inclusion Criteria:

1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
2. 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
3. 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
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'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.)
2. 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
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 dry red lip (vermillion), oral cavity, or nasal mucosa

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Primary outcomes:
measure: Event-Free Survival (EFS) as assessed by the investigator
timeFrame: Up to 1 year
measure: EFS as assessed by the investigator
timeFrame: Up to 3 years
Secondary outcomes:
measure: Composite Complete Response (CCR) for Target Lesion (TL)
timeFrame: At week 13
measure: Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)
timeFrame: Baseline and at week 13
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 3 years
measure: Severity of TEAEs
timeFrame: Up to 3 years
measure: Size of surgical defect
timeFrame: At week 13
measure: Size of biopsy defect
timeFrame: At week 13
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Delray Beach
country: United States
facility: Dermatology Associates of the Palm Beaches
state: Florida
city: Naperville
country: United States
facility: Oak Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research - Shadeland Ave.
state: Indiana
city: Beverly
country: United States
facility: University Skin Oncologists Inc
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Victor
country: United States
facility: Rochester Dermatologic Surgery, P.C.
state: New York
city: Bend
country: United States
facility: Dermatology Health Specialists
state: Oregon
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Reveal Research Institute
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: