Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
NCT ID: NCT06585410
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
369 participants
INTERVENTIONAL
2025-01-02
2030-05-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Arm
Investigational treatment
Cemiplimab
Administered per protocol
Control Arm
Standard of care treatment
Standard of care
Primary surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cemiplimab
Administered per protocol
Standard of care
Primary surgery
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Dermatology Specialists
Phoenix, Arizona, United States
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Stanford University
Redwood City, California, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Life Clinical Trials
Coral Springs, Florida, United States
Dermatology Associates of the Palm Beaches
Delray Beach, Florida, United States
University of South Florida
St. Petersburg, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Oak Dermatology
Naperville, Illinois, United States
Dawes Fretzin Clinical Research - Shadeland Ave.
Indianapolis, Indiana, United States
Equity Medical, LLC
Bowling Green, Kentucky, United States
US Dermatology Partners DBA DermAssociates, PC
Rockville, Maryland, United States
Northeast Dermatology Associates
Beverly, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
MyMichigan Dermatologic Oncology
Midland, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Dermatology and Skin Cancer Center
Lee's Summit, Missouri, United States
Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
St Louis, Missouri, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Metropolitan Dermatology
Clark, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States
Dermatology Health Specialists
Bend, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
The University of Texas at Austin Dell Medical School Ascension Medical Group
Austin, Texas, United States
Reveal Research Institute
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Epiphany Dermatology
Lewisville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
The Skin Hospital
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Dermatology Institute of Victoria (DIV)
South Yarra, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511812-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R2810-ONC-2251
Identifier Type: -
Identifier Source: org_study_id