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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
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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.
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I agree to use birth control during treatment and for 90 days after the last dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Activation of immune response
Secondary outcome measures
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 more

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
793,874 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,488 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
443 Total Patients Enrolled

Media Library

MEDI0562 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03336606 — Phase 1
Head and Neck Cancers Research Study Groups: Cohort II, Cohort I
Head and Neck Cancers Clinical Trial 2023: MEDI0562 Highlights & Side Effects. Trial Name: NCT03336606 — Phase 1
MEDI0562 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03336606 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~6 spots leftby Jun 2025