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Could a shot replace the knife for skin cancer?

NCT ID NCT06585410

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 9 times

Summary

This phase 3 trial tests whether injecting the drug cemiplimab directly into early-stage skin cancer tumors can work as well as surgery. About 369 people with small tumors on the head, neck, hand, or shin will be randomly assigned to get either the injections or standard surgery. The study will compare how long people stay cancer-free and track side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cemiplimab (Libtayo)
What this could lead to
If it works, this could offer a non-surgical option for early-stage skin cancer, potentially avoiding scars and recovery time.
What could go wrong
This is still experimental; cemiplimab may not work as well as surgery, and side effects from immune activation can occur. The trial is also limited to specific tumor sizes and locations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 369 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) 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 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, 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.) 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.

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Conditions

The condition(s) this trial relates to.

skin neoplasm skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous squamous cell carcinoma (CSCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    50 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Research Trials

    RECRUITING

    North Little Rock, Arkansas, 72117, United States

  • Buckeye Dermatology - Springfield Office

    RECRUITING

    Springfield, Ohio, 45505, United States

  • Center for Clinical Studies at Webster Clear Lake

    RECRUITING

    Webster, Texas, 77598, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinical Research Center of the Carolinas

    RECRUITING

    Charleston, South Carolina, 29407, United States

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

    RECRUITING

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dawes Fretzin Clinical Research - Shadeland Ave.

    WITHDRAWN

    Indianapolis, Indiana, 46250, United States

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

    RECRUITING

    Delray Beach, Florida, 33445, United States

  • Dermatology Health Specialists

    RECRUITING

    Bend, Oregon, 97702, United States

  • Dermatology Institute of Victoria (DIV)

    RECRUITING

    South Yarra, Victoria, 3141, Australia

  • Dermatology and Skin Cancer Center

    RECRUITING

    Lee's Summit, Missouri, 64064, United States

  • Epiphany Dermatology

    RECRUITING

    Lewisville, Texas, 75056, United States

  • Equity Medical, LLC

    WITHDRAWN

    Bowling Green, Kentucky, 42104, United States

  • Fremantle Dermatology

    RECRUITING

    Fremantle, Western Australia, 6160, Australia

  • George Washington University Medical Faculty Associates

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Las Vegas Dermatology

    RECRUITING

    Las Vegas, Nevada, 89144, United States

  • Life Clinical Trials

    RECRUITING

    Coral Springs, Florida, 33071, United States

  • Mayo Clinic - Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Medical Dermatology Specialists - Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Metropolitan Dermatology

    WITHDRAWN

    Clark, New Jersey, 07066, United States

  • MyMichigan Dermatologic Oncology

    RECRUITING

    Midland, Michigan, 48640, United States

  • Northeast Dermatology Associates

    RECRUITING

    Beverly, Massachusetts, 01915, United States

  • Oak Dermatology

    RECRUITING

    Naperville, Illinois, 60563, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Peak Dermatology, Aesthetics and Wellness

    RECRUITING

    Visalia, California, 93291, United States

  • Penn Medicine, Perelman Center For Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Penn State Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Profound Research, Dermatology Medical Group - Oceanside

    RECRUITING

    Oceanside, California, 92056, United States

  • Reveal Research Institute

    RECRUITING

    Dallas, Texas, 75235, United States

  • Rochester Dermatologic Surgery, P.C.

    RECRUITING

    Victor, New York, 14564, United States

  • Somerset Skin Centre

    RECRUITING

    Troy, Michigan, 48084, United States

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

  • StracSkin, PLLC

    RECRUITING

    Portsmouth, New Hampshire, 03801, United States

  • Texas Dermatology and Laser Specialists

    RECRUITING

    San Antonio, Texas, 78218, United States

  • The Skin Hospital

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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

    RECRUITING

    Austin, Texas, 78701, United States

  • U.S. Dermatology Partners

    RECRUITING

    Cedar Park, Texas, 78613, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

    RECRUITING

    Chapel Hill, North Carolina, 27516, United States

  • US Dermatology Partners DBA DermAssociates, PC

    RECRUITING

    Rockville, Maryland, 20850, United States

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Vcu Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

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

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.