Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or… (NCT03336606) | Clinical Trial Compass
CompletedPhase 1
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma
United States13 participantsStarted 2018-07-25
Plain-language summary
This clinical trial will evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.
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:
* Patients with advanced head and neck squamous cell carcinoma (HNSCC) or stage IIIb/IIIC melanoma who are candidates for R0 surgical resection
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Age 18 years or above
* Laboratory values:
* WBC ≥2000/uL
* Hgb \>8g/dl (patients may be transfused to reach this level)
* Platelets \>75,000 cells/mm3
* Serum creatinine 3 X upper limit of laboratory normal
* Negative bHCG (urine/serum) \[women of childbearing potential only\]
* AST (SGOT) and ALT (SGPT) \<2.5 X upper limit of laboratory normal
* Alkaline phosphatase \<2.5 X upper limit of laboratory normal
* Total bilirubin \<1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
* INR \<1.5, PT \<16 seconds, PTT \< 38 seconds
* Ability to give informed consent and comply with the protocol
* Anticipated lifespan \>12 weeks
* Women of childbearing potential: negative serum/urine pregnancy test \<96 hours prior to start of study
* Males and women of childbearing potential: must agree to take appropriate precautions to avoid pregnancy during treatment and through 90 days after last dose of IP
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/MedImmune staff and/or staff at the study site)
* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an intervent…
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.