MEDI0562 for Head and Neck Cancer and Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byBrenden Curti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

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.

Ability to give informed consent and comply with the protocol

You are expected to live for more than 12 weeks.

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Exclusion Criteria

Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

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.

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Treatment Details

Interventions

MEDI0562 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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)