A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

NCT04315701 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 14SK-19-1NCI-2020-01247P30CA014089
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions

Recurrent Skin Squamous Cell Carcinoma; Resectable Skin Squamous Cell Carcinoma; Stage I Skin Cancer; Stage II Skin Cancer; Stage III Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Confirmed pathologic partial response

  Defined by presence of \< 50% malignant cells. Descriptive statistics will be used to summarize the measurements.

  Up to 24 months after completion of study treatment

Secondary Outcomes (4)

• Pathologic complete response rate

  Up to 24 months after completion of study treatment

• Objective response rate

  At 9 weeks

• Progression-free survival

  From start of treatment to time of progression or death whichever comes first, assessed at 12 months

• Incidence of toxicities

  Up to 24 months after completion of study treatment

Study Arms (1)

Treatment (cemiplimab, surgical resection)

EXPERIMENTAL

Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.

Biological: Cemiplimab; Procedure: Resection

Interventions

Cemiplimab BIOLOGICAL

Given IV

Also known as: Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810

Treatment (cemiplimab, surgical resection)

Resection PROCEDURE

Undergo surgical resection

Also known as: Surgical Resection

Treatment (cemiplimab, surgical resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed, cutaneous squamous cell carcinoma
• Patients must have disease that is deemed potentially resectable, at the time of the start of study, by the treating investigator. The decision to perform surgery on patients must be based on good clinical judgment. Eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed potentially resectable, resulting in free surgical margins
• Patients must have measurable disease
• Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC. The criteria specific to each of these populations is listed below
• For patients with high-risk localized CSCC, at least two of the following clinical or pathologic high-risk features must be present to be eligible:
• Clinical risk factors
• Any tumor size \> 2.0 cm in diameter
• Tumors \> 1.0 cm in high risk locations, including "mask areas" (central face, eyelids, eyebrow, nose, lips \[cutaneous\], periorbital, chin, mandible, preauricular and postauricular skin/sulci, genitalia, hands, feet, cheek, forehead, scalp, neck and pretibial)
• Any rapidly growing and/or symptomatic tumor
• Pathologic risk factors
• Poorly differentiated histology
• Depth \> 6 mm in thickness
• Acantholytic / adenoid, adenosquamous, desmoplastic, or metaplastic / carcinosarcomatous histologic subtypes
• Invasion beyond subcutaneous fat
• Perineural, lymphatic, or vascular involvement

You may not qualify if:

• Metastatic disease that is unresectable. Patients with visceral metastases are not eligible. Regionally advanced disease, including in-transit, cutaneous, subcutaneous, or nodal metastases are allowed, if deemed potentially resectable by the investigator
• Prior treatment with cemiplimab or any other agent that blocks the PD-1 or PD-L1 pathway
• Prior treatment with other immune modulating agents within fewer than 4 weeks, prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB, OX-40, therapeutic vaccines, or cytokine therapies
• Patients must not be receiving other concomitant biologic therapy, hormonal therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
• Radiation therapy, non-cytotoxic agents or investigational agents in the 4 weeks prior to registration
• Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first dose of cemiplimab
• Any major surgery within 14 days prior to the first dose of cemiplimab. Patients must have recovered from any major complications before registration
• Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
• History of other prior malignancy in the last five years, with the exception of: adequately treated non-melanoma skin cancers (including multiple primary skin cancers), adequately treated in situ cancer, and other local tumors considered cured by local treatment (including melanoma)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab or any other PD-1 or PD-L1 inhibitor
• Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
• Positive pregnancy test, active pregnancy or nursing / breast-feeding, due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• History solid organ or bone marrow transplantation

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gino K In, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: June 17, 2020
• Primary Completion: November 12, 2025
• Study Completion (Estimated): June 17, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (5)