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Recurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckPhase 2NCT03565783

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

A Phase 2 study testing Cemiplimab in people with Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
3 Jul 2018to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
  • Active tuberculosis.
  • 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.
  • Received oral or IV antibiotics 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.
  • Major surgical procedure within 28 days prior to cycle 1, day 1.
  • 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 study.
  • Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, 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 ligation.)
  • 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 allowed.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Patients with prior treatment with idelalisib.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

OUTLINE:

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.

Being tested
Cemiplimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810

    Given IV

Study groups in NCT03565783
Study groupRoleWhat they receive
Treatment (cemiplimab)ExperimentalPatients 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.
Receives: Biological: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

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

    Measured: Up to 6 weeks

Secondary outcomes (5)

  1. Time to recurrence

    The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 5 years

  2. Patterns of failure

    Summary statistics will be provided for continuous variables.

    Measured: Up to 5 years

  3. Disease-specific survival

    Frequency tables will be used to summarize categorical variables.

    Measured: Up to 2 years

  4. Disease-free survival

    The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 5 years

  5. Overall survival

    The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start3 Jul 2018
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03565783
Sponsor's protocol ID
2017-0332
Other IDs
NCI-2018-01313, 2017-0332
Status last verified
Jul 2026
First submitted
12 Jun 2018
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 34187851

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab in people with Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03565783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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