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New shot shrinks skin cancer before surgery, early study shows promise

NCT ID NCT03889912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tested a drug called cemiplimab, which helps the immune system attack cancer cells. The drug was injected directly into skin tumors (squamous cell or basal cell carcinoma) for 3 to 12 weeks before planned surgery. The main goal was to check safety and find the right dose. The study involved 97 people and looked at how well the drug shrank the tumor before it was removed.

What this could mean

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

Active substance
cemiplimab (a drug that helps the immune system fight cancer)
What this could lead to
If successful, this approach could offer a less invasive way to shrink skin cancers before surgery, potentially reducing the extent of surgery needed.
What could go wrong
This is an early phase 1 trial focused on safety, so effectiveness is not yet proven. Side effects, including injection reactions, are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

97 people

The number who actually took part.

Started

Apr 2019

Finished

Dec 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 1. Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol 2. Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Key Exclusion Criteria 1. 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) 2. Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway. 3. Prior treatment with other systemic immune modulating agent as defined in the protocol 4. M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years 5. Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded. 6. Patients with a history of solid organ transplant 7. Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication Note: Other protocol defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma skin squamous cell carcinoma

As listed by the trial registrant

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

Basal cell carcinoma Cutaneous squamous cell carcinoma

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Dermatology Associates of the Palm Beaches

    Delray Beach, Florida, 33445, United States

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fremantle Dermatology

    Fremantle, Western Australia, 6160, Australia

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Maastricht University Medical Center

    Maastricht, Limburg, 6202 AZ, Netherlands

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006, United States

  • MetroDerm

    Atlanta, Georgia, 30342, United States

  • Northeast Dermatology Associates

    Beverly, Massachusetts, 01915, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102, Australia

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6500 HB, Netherlands

  • Rochester Dermatologic Surgery, P.C.

    Victor, New York, 14564, United States

  • TCR Medical Corporation

    San Diego, California, 92123, United States

  • The Netherlands Cancer Institute - Antoni van Leeuwenhoek

    Amsterdam, North Holland, 1066 CX, Netherlands

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Groningen, University Medical Centre Groningen

    Groningen, 9700 RB, Netherlands

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