Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutane… (NCT06580054) | Clinical Trial Compass
RecruitingPhase 2
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
United States22 participantsStarted 2025-03-05
Plain-language summary
This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and/or periorbital cSCC.
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:
* Male/female participants who are at least 18 years of age on the day of signing informed consent.
* Histologically confirmed diagnosis of locally advanced or diffuse or recurrent orbital or periorbital cutaneous squamous cell carcinoma.
* Female participants:
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP) as defined.
* A WOCBP who agrees to follow the contraception guidance during the treatment period and for at least 120 days after the last dose of study treatment.
* The participant provides written informed consent for the trial.
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Absolute neutrophil count (ANC) ≥ 1500/uL.
* Platelets ≥ 100000/uL.
* Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L.
* Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) ≥ 30 mL/min for partici…
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.