Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery

NCT03565783 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2017-0332NCI-2018-01313
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) 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

Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck; Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.

  Up to 6 weeks

Secondary Outcomes (5)

• Time to recurrence

  Up to 5 years

• Patterns of failure

  Up to 5 years

• Disease-specific survival

  Up to 2 years

• Disease-free survival

  Up to 5 years

• Overall survival

  Up to 5 years

Other Outcomes (1)

• Incidence of adverse events

  Up to 5 years

Study Arms (1)

Treatment (cemiplimab)

EXPERIMENTAL

Patients receive cemiplimab IV over 30 minutes every 3 weeks. Cycles repeat every 3 weeks for up to 6 weeks with or without radiation therapy at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

Biological: Cemiplimab

Interventions

Cemiplimab BIOLOGICAL

Given IV

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

Treatment (cemiplimab)

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven, primary or recurrent stage II-IV cutaneous squamous cell carcinoma of the head and neck.
• Surgical resection must be planned as primary therapy with or without adjuvant radiation therapy. Patients are eligible with previous surgical intervention if they have residual or recurrent disease, and it is greater than 4 weeks since surgery and they have fully recovered from surgery.
• Signed informed consent form (ICF).\*
• Ability and willingness to comply with the requirements of the study protocol.\*
• Age \>= 18 years.
• Absolute neutrophil count (ANC) \>= 1500 cells/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• White blood cell (WBC) counts \>= 2500/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Lymphocyte count \>= 300/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Platelet count \>= 100,000uL for patients with hematologic malignancies, platelet count \>= 75,000/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Hemoglobin \>= 9.0 g/dL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Alkaline phosphatase =\< 2.5 x ULN with the following exception: patients with documented bone metastases: alkaline phosphatase =\< 5 x ULN (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Serum creatinine =\< 1.5 x ULN or creatinine clearance \>= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Measurable disease per RECIST v1.1 and/or per direct clinical measurements for primary tumors upon a variance between clinical and radiographic evaluation.

You may not qualify if:

• Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: Hormone-replacement therapy; palliative radiotherapy for bone metastases \> 2 weeks prior to cycle 1, day 1.
• Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =\< 1 except for alopecia.
• Bisphosphonate therapy for symptomatic hypercalcemia
• Use of bisphosphonate therapy for other reasons (e.g., osteoporosis) is allowed.
• Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
• Pregnancy, lactation, or breastfeeding.
• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
• Inability to comply with study and follow-up procedures.
• History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible.
• Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations; Rash must cover less than 10% of body surface area (BSA); Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%); No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
• History of radiation pneumonitis in the radiation field \[fibrosis\] is permitted.
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
• History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection.
• Patients with past or resolved hepatitis B infection; defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive anti-HBc (antibody to hepatitis B core antigen) antibody test, are eligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ferrarotto R, Amit M, Nagarajan P, Rubin ML, Yuan Y, Bell D, El-Naggar AK, Johnson JM, Morrison WH, Rosenthal DI, Glisson BS, Johnson FM, Lu C, Mott FE, Esmaeli B, Diaz EM Jr, Gidley PW, Goepfert RP, Lewis CM, Weber RS, Wargo JA, Basu S, Duan F, Yadav SS, Sharma P, Allison JP, Myers JN, Gross ND. Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2021 Aug 15;27(16):4557-4565. doi: 10.1158/1078-0432.CCR-21-0585. Epub 2021 Jun 29.

  PMID: 34187851 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

cemiplimab

Study Officials

• Neil D Gross, MD

  M.D. Anderson Cancer Center

  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: June 12, 2018
• First Posted: June 21, 2018
• Study Start: July 3, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)