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Monoclonal Antibodies
MEDI0562 for Head and Neck Cancer and Melanoma
Phase 1
Waitlist Available
Led By Brenden Curti, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
History of allogenic organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma or stage IIIb/IIIC melanoma who are candidates for surgery. They must have a life expectancy over 12 weeks, acceptable organ function, no major surgeries within the last 28 days, and not be on immunosuppressive meds recently. Women must test negative for pregnancy and agree to contraception.
What is being tested?
The trial studies MEDI0562, an OX40 agonist, in patients before they undergo surgical removal of their cancer. It aims to assess the safety of this drug when given prior to surgery and whether it's feasible as a pre-operative treatment option.
What are the potential side effects?
While specific side effects aren't listed here, similar drugs often cause immune-related reactions such as inflammation in various organs, skin rashes or itching, fatigue, possible infusion-related symptoms like fever or chills, and may affect liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced head and neck cancer or stage IIIb/IIIC melanoma and can undergo complete surgical removal.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.
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I have received an organ transplant from another person.
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I do not have any serious ongoing illnesses that could affect my participation in the study.
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I have had diverticulitis recently or currently have it.
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I have not received a live vaccine in the last 30 days.
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I do not have an active infection like TB, hepatitis B, C, or HIV.
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I have or had an autoimmune or inflammatory disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Activation of immune response
Secondary study objectives
Cancer-related clinical outcomes (overall survival)
Cancer-related clinical outcomes (progression free survival)
Incidence of Treatment-Emergent Adverse Events in patients with HNSCC or melanoma treated with MEDI0562 (Safety & Tolerability)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Cohort IIActive Control1 Intervention
MEDI0562 administration (30mg on days 1, 3, 5) followed by surgical resection (day 15)
Group II: Cohort IActive Control1 Intervention
MEDI0562 administration (90mg on day 1) followed by surgical resection (day 15)
Find a Location
Who is running the clinical trial?
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,445 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
123 Previous Clinical Trials
823,758 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
443 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II
- Group 2: Cohort I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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