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MEDI0562 for Head and Neck Cancer and Melanoma
Study Summary
This trial will see if it's safe to use MEDI0562, a humanized OX40 agonist, before surgery for people with head and neck squamous cell carcinoma or melanoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't taken any experimental cancer treatments in the last 28 days.I am not on any cancer treatments but may be on hormone therapy for other reasons.I have received an organ transplant from another person.Your white blood cell count, hemoglobin level, platelet count, kidney function, liver enzymes, and blood clotting time must be within certain normal ranges. If you are a woman able to have children, you must have a negative pregnancy test.You are expected to live for more than 12 weeks.I do not have any serious ongoing illnesses that could affect my participation in the study.I don't have lasting side effects from cancer treatment, except for possible hair loss, skin color changes, or specific lab value changes.I have had diverticulitis recently or currently have it.I am able to care for myself and perform daily activities.I've had local treatment for cancer relief, like surgery or radiotherapy.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.I have not had major surgery within the last 28 days.I had cancer before, but it was either treated over 1.5 years ago, was a non-dangerous skin cancer, or was a localized cancer that did not spread.I haven't taken immunosuppressive drugs in the last 14 days.I have not received a live vaccine in the last 30 days.I have advanced head and neck cancer or stage IIIb/IIIC melanoma and can undergo complete surgical removal.I am 18 years old or older.I agree to use birth control during treatment and for 90 days after the last dose.I have nerve damage that affects my daily activities.Women who could become pregnant must have a negative pregnancy test within 96 hours before the study starts.You have a history of a weakened immune system that is currently active.I do not have an active infection like TB, hepatitis B, C, or HIV.I have or had an autoimmune or inflammatory disorder.
- Group 1: Cohort II
- Group 2: Cohort I
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this medical research actively searching for new participants?
"Unfortunately, the trial is not actively recruiting at this time. It was initially posted on July 25th 2018 and last updated on July 13th 2022. If you are intent in finding other studies, 3514 trials for melanoma patients are currently open to candidates as well as one study concerning Cohort II participants."
Has the FDA validated Cohort II?
"Given the limited data that supports Cohort II's safety and efficacy, it was assigned a score of 1."
Is this pioneering clinical trial the inaugural of its kind?
"Presently, the only active trial for Cohort II is occurring in one city and nation. This research project was initially conducted by MedImmune LLC back in 2018 with 35 participants completing its Phase 1 drug approval stage. Since then, 3 additional studies have concluded successfully."
Could you enumerate any previous research that utilized Cohort II?
"Currently, there is one open trial for Cohort II at the Phase 3 level. Portland, Oregon has a number of active trials in this cohort and it remains the only site running such studies."
How many participants are eligible to join this research?
"At present, the trial is not accruing participants. Initially posted on July 25th 2018 and most recently updated on July 13th 2022, this study is no longer taking partipants. However there are currently 3514 trials actively recruiting patients with melanoma and 1 clinical trial for Cohort II accepting volunteers."
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