Phase II Study of REGN2810 Prior to Surgery in Patients With Stage II-IV Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 27 October 2022


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.



I. To determine the overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria to neoadjuvant cemiplimab (REGN2810) in patients with stage II-IV cutaneous squamous cell carcinoma (cSCC) of the head and neck who are planned for definitive local surgery with or without radiation.


I. To determine the pathologic response rate to neoadjuvant REGN2810 in patients with stage II-IV cSCC of the head and neck.

II. To determine the safety and tolerability of neoadjuvant REGN2810 in patients with stage II-IV cSCC of the head and neck who are planned for definitive local surgery and radiation.

III. To estimate the 2-year disease-specific (DSS), disease-free (DFS) and overall survival (OS) compared to historical controls.

IV. To determine the time to recurrence and patterns of failure. V. To evaluate the effects of neoadjuvant REGN2810 on the expression of PD-1 and potential related immune regulating targets in cSCC of the head and neck.


Patients receive cemiplimab intravenously (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.

After completion of study treatment, patients are followed up for 30 days and then periodically for up to 5 years.

Condition Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, 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
Treatment REGN2810, Cemiplimab
Clinical Study IdentifierNCT03565783
SponsorM.D. Anderson Cancer Center
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation [such as low-molecular-weight heparin or warfarin] should be on a stable dose.)
No evidence of distant metastases and measurable disease (> 1.5 cm)
Please Note
Patients may be enrolled regardless of their language. The ICD / translator SOP will be
followed for Non-English speaking patients
Cognitively-Impaired adults may be considered for this protocol. If so, the ICD / LAR SOP
will be followed

Exclusion Criteria

Bisphosphonate therapy for symptomatic hypercalcemia
Use of bisphosphonate therapy for other reasons (e.g., osteoporosis) is allowed
Pregnancy, lactation, or breastfeeding
Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or
Inability to comply with study and follow-up procedures
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 =<
except for alopecia
Active tuberculosis
History of radiation pneumonitis in the radiation field [fibrosis] is permitted
Any other diseases, metabolic dysfunction, physical examination finding, or clinical
chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory
laboratory finding giving reasonable suspicion of a disease or condition that
Major surgical procedure within 28 days prior to cycle 1, day 1
contraindicates the use of an investigational drug or that may affect the
Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies
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
Received oral or IV antibiotics within 2 weeks prior to cycle 1, day 1
autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be
Patients with prior treatment with idelalisib
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
Malignancies other than the disease under study within 5 years prior to cycle 1, day
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 severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
interpretation of the results or render the patient at high risk from treatment
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
Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia
Signs or symptoms of infection as determined by the treating team within 2 weeks prior
to cycle 1, day 1
Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary
tract infection or chronic obstructive pulmonary disease) are eligible
Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or
anticipation that such a live, attenuated vaccine will be required during the study
Influenza vaccination should be given during influenza season only (approximately
October to March). Patients must not receive live, attenuated influenza vaccine
(e.g., FluMist) within 4 weeks prior to cycle 1, day 1 or at any time during the
with the exception of those with a negligible risk of metastasis or death and with
expected curative outcome (such as adequately treated carcinoma in situ of the cervix
basal or squamous cell skin cancer, localized prostate cancer treated surgically with
curative intent, or ductal carcinoma in situ treated surgically with curative intent)
or undergoing active surveillance per standard-of-care management (e.g., chronic
lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and
prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Continued sexual activity in men or women of childbearing potential who are
unwilling to practice highly effective contraception during the study and until 6
months after the last dose of study drug (highly effective contraceptive measures
include stable use of oral contraceptives such as combined estrogen and progestogen
and progestogen only hormonal contraception or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
[IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal ligation
vasectomy, and sexual abstinence). (Contraception is not required for men with
documented vasectomy Postmenopausal women must be amenorrheic for at least 12
months in order not to be considered of childbearing potential. Pregnancy testing and
contraception are not required for women with documented hysterectomy or tubal
Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway
targeting agents. Patients who have received prior treatment with anti-CTLA-4 may be
enrolled, provided the following requirements are met: Minimum of 12 weeks from the
first dose of anti-CTLA-4 and > 6 weeks from the last dose. No history of severe
immune-related adverse effects from anti-CTLA 4 (National Cancer Institute [NCI]
Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)
Treatment with systemic immunostimulatory agents (including but not limited to
interferon [IFN] or interleukin [IL]-2) within 6 weeks or five half-lives of the drug
(whichever is shorter) prior to cycle 1, day 1
Treatment with investigational agent within 4 weeks prior to cycle 1, day 1 (or within
five half lives of the investigational product, whichever is longer)
Treatment with systemic immunosuppressive medications (including but not limited to
prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor
necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1
Patients who have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)
for patients with orthostatic hypotension or adrenocortical insufficiency is
Patients with prior allogeneic bone marrow transplantation or prior solid organ
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