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Shrinking skin cancer before surgery: new drug shows promise

NCT ID NCT04154943

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested giving the drug cemiplimab before surgery to people with advanced skin cancer (stage II to IV). The goal was to see if the drug could shrink or eliminate the tumor before the operation. 79 adults took part. The main focus was on how many patients had no cancer cells left in the removed tissue.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Mar 2020

Finished

Nov 2025

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 * Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter. * At least 1 lesion that is measurable by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ, bone marrow function, and hepatic function as defined in the protocol Key Exclusion Criteria * Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia \[CLL\]) at any time * Distant metastatic disease (M1), visceral and/or distant nodal * Prior radiation therapy for CSCC * Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug. * Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. * History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. * Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency * Active tuberculosis NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

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Conditions

The condition(s) this trial relates to.

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

Contacts and locations

Locations

  • Regeneron Study Site

    Palo Alto, California, 94304, United States

  • Regeneron Study Site

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

  • Regeneron Study Site

    Miami, Florida, 33176, United States

  • Regeneron Study Site

    Tampa, Florida, 33612, United States

  • Regeneron Study Site

    Baltimore, Maryland, 21231, United States

  • Regeneron Study Site

    Boston, Massachusetts, 02114, United States

  • Regeneron Study Site

    Boston, Massachusetts, 02215, United States

  • Regeneron Study Site

    Ann Arbor, Michigan, 48109, United States

  • Regeneron Study Site

    Omaha, Nebraska, 68114, United States

  • Regeneron Study Site

    New York, New York, 10065, United States

  • Regeneron Study Site

    Charlotte, North Carolina, 28204, United States

  • Regeneron Study Site

    Durham, North Carolina, 27710, United States

  • Regeneron Study Site

    Cleveland, Ohio, 44195, United States

  • Regeneron Study Site

    Dallas, Texas, 75390, United States

  • Regeneron Study Site

    Houston, Texas, 77030, United States

  • Regeneron Study Site

    St Leonards, New South Wales, 2065, Australia

  • Regeneron Study Site

    Herston, Queensland, 4029, Australia

  • Regeneron Study Site

    Melbourne, Victoria, 3000, Australia

  • Regeneron Study Site

    Dresden, 01307, Germany

  • Regeneron Study Site

    Essen, 45147, Germany

  • Regeneron Study Site

    Kiel, 24105, Germany

  • Regeneron Study Site

    Tübingen, 72076, Germany

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