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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06585410




Registration number
NCT06585410
Ethics application status
Date submitted
3/09/2024
Date registered
5/09/2024
Date last updated
9/07/2025

Titles & IDs
Public title
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Scientific title
A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
Secondary ID [1] 0 0
2024-511812-26-00
Secondary ID [2] 0 0
R2810-ONC-2251
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma (CSCC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cemiplimab
Treatment: Surgery - Standard of care

Experimental: Experimental Arm - Investigational treatment

Other: Control Arm - Standard of care treatment


Treatment: Drugs: Cemiplimab
Administered per protocol

Treatment: Surgery: Standard of care
Primary surgery
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS) as assessed by the investigator
Timepoint [1] 0 0
Up to 1 year
Primary outcome [2] 0 0
EFS as assessed by the investigator
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Composite Complete Response (CCR) for Target Lesion (TL)
Timepoint [1] 0 0
At week 13
Secondary outcome [2] 0 0
Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)
Timepoint [2] 0 0
Baseline and at week 13
Secondary outcome [3] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Severity of TEAEs
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Size of surgical defect
Timepoint [5] 0 0
At week 13
Secondary outcome [6] 0 0
Size of biopsy defect
Timepoint [6] 0 0
At week 13

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/05/2030
Actual
Sample size
Target
369
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Skin Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Dermatology Institute of Victoria (DIV) - South Yarra
Recruitment hospital [4] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3141 - South Yarra
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06585410