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Cutaneous Squamous Cell Carcinoma (CSCC)Phase 3NCT06585410

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

A Phase 3 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma (CSCC), run by Regeneron Pharmaceuticals at 53 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous Squamous Cell Carcinoma (CSCC)
What is being tested?
Cemiplimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
369 participants
Where
53 sitesin 2 countries
Study dates
2 Jan 2025to 3 May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

53 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

53 sites in 2 countries

United States48 sites, 45 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87102

    Recruiting

  • The University of Texas at Austin Dell Medical School Ascension Medical Group

    Austin, Texas, 78701

    Recruiting

  • Dermatology Health Specialists

    Bend, Oregon, 97702

    Recruiting

  • Northeast Dermatology Associates

    Beverly, Massachusetts, 01915

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Equity Medical, LLC

    Bowling Green, Kentucky, 42104

    Withdrawn

  • U.S. Dermatology Partners

    Cedar Park, Texas, 78613

    Recruiting

  • UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

    Chapel Hill, North Carolina, 27516

    Recruiting

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • Metropolitan Dermatology

    Clark, New Jersey, 07066

    Withdrawn

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Life Clinical Trials

    Coral Springs, Florida, 33071

    Recruiting

  • Reveal Research Institute

    Dallas, Texas, 75235

    Recruiting

  • Dermatology Associates of the Palm Beaches, Integri Research at Dermatology Associates

    Delray Beach, Florida, 33445

    Recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Dawes Fretzin Clinical Research - Shadeland Ave.

    Indianapolis, Indiana, 46250

    Withdrawn

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Recruiting

  • Las Vegas Dermatology

    Las Vegas, Nevada, 89144

    Recruiting

  • Dermatology and Skin Cancer Center

    Lee's Summit, Missouri, 64064

    Recruiting

  • Epiphany Dermatology

    Lewisville, Texas, 75056

    Recruiting

  • MyMichigan Dermatologic Oncology

    Midland, Michigan, 48640

    Recruiting

  • Oak Dermatology

    Naperville, Illinois, 60563

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

    Recruiting

  • Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion

    New York, New York, 10032

    Recruiting

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

    Recruiting

  • Profound Research, Dermatology Medical Group - Oceanside

    Oceanside, California, 92056

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Penn Medicine, Perelman Center For Advanced Medicine

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Medical Dermatology Specialists - Phoenix

    Phoenix, Arizona, 85006

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Recruiting

  • StracSkin, PLLC

    Portsmouth, New Hampshire, 03801

    Recruiting

  • Stanford University

    Redwood City, California, 94063

    Recruiting

  • Vcu Massey Cancer Center

    Richmond, Virginia, 23298

    Recruiting

  • US Dermatology Partners DBA DermAssociates, PC

    Rockville, Maryland, 20850

    Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

    Recruiting

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

    Recruiting

  • Buckeye Dermatology - Springfield Office

    Springfield, Ohio, 45505

    Recruiting

  • Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery

    St Louis, Missouri, 63141

    Recruiting

  • University of South Florida

    Tampa, Florida, 33612

    Recruiting

  • Somerset Skin Centre

    Troy, Michigan, 48084

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Recruiting

  • Rochester Dermatologic Surgery, P.C.

    Victor, New York, 14564

    Recruiting

  • Peak Dermatology, Aesthetics and Wellness

    Visalia, California, 93291

    Recruiting

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

    Recruiting

  • Center for Clinical Studies at Webster Clear Lake

    Webster, Texas, 77598

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting

  • The Skin Hospital

    Darlinghurst, New South Wales, 2010

    Recruiting

  • Fremantle Dermatology

    Fremantle, Western Australia, 6160

    Recruiting

  • Dermatology Institute of Victoria (DIV)

    South Yarra, Victoria, 3141

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

About this study

Official title: 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
Being tested
Cemiplimab, Standard of care
Keywords
Dermato-Oncology, Cemiplimab, Early Stage, Skin Cancer, Non-Melanoma Skin Cancer, UV Skin Damage, Chronic Sun Exposure
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called Libtayo

    Administered per protocol

  • Standard of careProcedure or surgery

    Primary surgery

Study groups in NCT06585410
Study groupRoleWhat they receive
Experimental ArmExperimentalNot described
Receives: Drug: Cemiplimab
Control ArmOtherNot described
Receives: Procedure: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free Survival (EFS) as assessed by the investigator

    Measured: Up to 1 year

  2. EFS as assessed by the investigator

    Measured: Up to 3 years

Secondary outcomes (6)

  1. Composite Complete Response (CCR) for Target Lesion (TL)

    Experimental Arm

    Measured: At week 13

  2. Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)

    Experimental Arm

    Measured: Baseline and at week 13

  3. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 3 years

  4. Severity of TEAEs

    Measured: Up to 3 years

  5. Size of surgical defect

    Measured: At week 13

  6. Size of biopsy defect

    Measured: At week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2024
  2. Study start2 Jan 2025
  3. Primary completion3 May 2030 (estimated)
  4. Study completion3 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
369 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585410
Sponsor's protocol ID
R2810-ONC-2251
Status last verified
Sep 2026
First submitted
3 Sep 2024
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma (CSCC), run by Regeneron Pharmaceuticals at 53 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free Survival (EFS) as assessed by the investigator (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06585410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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