Cemiplimab for Skin Cancer

Recruiting at 11 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Immunosuppressants

Disqualifiers: Autoimmune disease, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

369 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Adults with early-stage cutaneous squamous cell carcinoma (CSCC) that's between 1 and 2 cm in size, located on the head, neck, hand, or shin. Candidates should be fit for surgery and have good liver, kidney, and bone marrow function. Those who are planned to undergo surgical excision without margin control cannot participate.

Inclusion Criteria

My cancer is a confirmed invasive cutaneous squamous cell carcinoma.

My skin cancer is between 1 and 2 cm in size and is on my head, neck, hand, or shin.

I am fully active or can carry out light work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intralesional cemiplimab or undergo primary surgery for early-stage cutaneous squamous cell carcinoma

13 weeks

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cemiplimab

Trial Overview The trial is testing cemiplimab injected directly into CSCC lesions versus standard surgical treatment. Cemiplimab is an immunotherapy drug that targets PD-1 proteins on immune cells to help destroy cancer cells.

Participant Groups

Group I: Experimental Arm Experimental Treatment 1 Intervention

Investigational treatment

Group II: Control Arm Experimental Treatment 1 Intervention

Standard of care treatment

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School