Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous… (NCT03565783) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery
United States44 participantsStarted 2018-07-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 t…