Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

NCT04428671 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: IRB00115160NCI-2019-07373Winship4851-19P30CA138292
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.

Conditions

Metastatic Skin Squamous Cell Carcinoma; Recurrent Skin Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathologic response rate

  Defined as the number of complete and partial responses divided by the total number of patients, as assessed by pathology. Pathological complete response (pCR) (no viable tumor) or pathological partial response (pPR) (less than 50% viable tumor) as well as near pCR (less than 10% viable tumor) in the tumor bed will be documented by pathology from the resection specimen. Pathologic response rate will be summarized using frequency and percentage, and a 95% exact confidence interval will be reported using the Clopper-Pearson method.

  From screening up to 10 years post-treatment

Secondary Outcomes (4)

• Time to local recurrence

  From screening to local recurrence, death, or last known follow-up, assessed up to 10 years post-treatment

• Time to systemic recurrence

  From screening to systemic recurrence, death, or last known follow-up, assessed up to 10 years post-treatment

• Overall survival (OS)

  From screening to death from any cause or last known follow-up, assessed up to 2 years post-treatment

• Recurrence-free survival (RFS)

  From screening to recurrence, death, or last known follow-up, assessed up to 2 years post-treatment

Other Outcomes (1)

• Change in immune system biomarkers

  From baseline up to 10 years post-treatment

Study Arms (1)

Treatment (cemiplimab)

EXPERIMENTAL

NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ADJUVANT PHASE: Within 2-6 weeks after standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

Biological: Cemiplimab; Radiation: Radiation Therapy; Procedure: Therapeutic Conventional Surgery

Interventions

Cemiplimab BIOLOGICAL

Given IV

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

Treatment (cemiplimab)

Radiation Therapy RADIATION

Undergo standard of care radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (cemiplimab)

Therapeutic Conventional Surgery PROCEDURE

Undergo standard of care surgery

Treatment (cemiplimab)

Eligibility Criteria

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

You may qualify if:

• Patient must have a known diagnosis of high risk cSCC defined by the following criteria:
• Nodal disease with extracapsular extension (ECE) and at least one node \>= 20 mm on the surgical pathology report
• In-transit metastases (ITM) defined as skin or subcutaneous metastases that are \> 2 cm from the primary lesion but are not beyond the regional nodal basin
• T4 lesion for head and neck CSCC
• Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves
• Recurrent CSCC, defined as CSCC that arises within the area of the previously resected tumor, or at least one of the following additional features:
• \>= N2b disease associated with the recurrent lesion
• Nominal \>= T3 (recurrent lesion \>= 4 cm in diameter or minor bone erosion or deep invasion \> 6 mm measured from the granular layer of normal adjacent epithelium)
• Poorly differentiated histology and \>= 20 mm diameter of recurrent lesion. The recurrent lesion must be documented to be within the area of the previously resected CSCC by radial measurement of the greatest radius of the final defect, measured from the estimated center of the original surgical wound
• Cancer confirmed to be surgically resectable, with surgery evaluation with planned prior to resection
• No prior systemic immunotherapy, no prior anti-PD1 therapy
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Hemoglobin \>= 9.0 g/dl (within 28 days of cycle 1 day 1)
• Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of cycle 1 day 1)
• Platelets \>= 100,000/mcL (within 28 days of cycle 1 day 1)

You may not qualify if:

• Determined not to be a surgical candidate due to medical co-morbidities or extent of disease
• Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
• Prior organ allograft or allogeneic bone marrow transplantation
• Subjects with active or history of immune mediated pneumonitis, colitis, hepatitis, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence of their immune mediated disease, potentially delaying surgery
• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
• Women who are pregnant or lactating
• Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
• Clinical evidence of bleeding diathesis or coagulopathy
• Subjects with a history of severe allergic reactions
• Patients with prior malignancies, are eligible if they have been disease free for \> 3 years
• Patients with prior low-risk non-melanoma skin cancers and in situ carcinomas are eligible provided there was complete removal
• Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
• History of severe hypersensitivity reactions to other monoclonal antibodies
• Non-oncology vaccines within 28 days prior to starting treatment

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Interventions

cemiplimab; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Michael Lowe, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lowe, MD

CONTACT

404-778-6351; mlowe3@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: May 15, 2020
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)