Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head a… (NCT02769520) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck
United States27 participantsStarted 2016-07-06
Plain-language summary
The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.
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:
* Has pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx) with evidence of local and/or locoregional recurrence. Laryngeal tumors will only be included if there is evidence of extralaryngeal spread, or there is associated nodal disease. For all other sites, superficial tumors can only be included if there is associated nodal disease.
* Has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy.
* Candidate for salvage resection.
* Able to provide tissue from diagnostic core biopsy of tumor lesion(s).
* Patient has adequate organ function.
* Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication.
* Female patient of childbearing potential agrees to use adequate birth control.
* Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
* Patient has disease of nasopharyngeal carcinoma histology.
* Patient has evidence of metastatic disease.
* Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day 1.
* Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembroliz…
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.