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Immunotherapy for Recurrent Head and Neck Cancer

Phase < 1

Recruiting

Led By Haythem Ali, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test whether immunotherapy can help people with recurrent head and neck cancer after surgery.

Who is the study for?

This trial is for adults with recurrent squamous cell carcinoma of the head and neck, except in certain areas like nasopharynx. They must have tried surgery, radiation, or chemotherapy before and can't be eligible for salvage radiation therapy now. They should not have other cancers (with some exceptions) or have used immunotherapy within the last year.

What is being tested?

The study tests Pembrolizumab as a follow-up treatment after surgical removal of cancer to see if it's effective and feasible. It's given intravenously and aims to help patients whose cancer has returned despite previous treatments.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs, allergic reactions, fatigue, skin issues, hormone gland problems (like thyroid), and could potentially worsen pre-existing autoimmune diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).

Secondary study objectives

Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.

Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.

Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.