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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.