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PD-1 Inhibitor

Immunotherapy + Radiation for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Jonathan D. Schoenfeld, MD MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed squamous cell carcinoma of the head and neck with evidence of metastatic disease considered incurable by local therapies

ECOG performance status <=1

Must not have

Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms

Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding immunotherapy to radiation therapy can help people with head and neck cancer.

Who is the study for?

Adults with confirmed metastatic squamous cell carcinoma of the head and neck, who have not benefited from previous PD-1 therapy, can join. They must be in good health otherwise, with proper organ function and no serious heart issues or infections like hepatitis. Pregnant women and those with certain other cancers or autoimmune diseases cannot participate.

What is being tested?

The trial is testing pembrolizumab (KEYTRUDA), an immunotherapy drug, combined with radiation therapy to treat advanced head & neck cancer. The study aims to see if this combination helps patients whose cancer has spread despite prior treatments.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid disorders), and infusion-related reactions. Radiation could lead to skin irritation at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type that started in my head or neck and has spread, with no cure from surgery or radiation.

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I am fully active or can carry out light work.

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My cancer progressed or didn't improve after treatment with a PD-1 inhibitor.

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I have at least 3 tumors outside the brain that can be measured and haven't been treated with radiation.

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I haven't had chemotherapy, immunotherapy, or experimental drugs for at least 2 weeks.

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I am not receiving any other cancer treatments while in this study.

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I am 18 or older and can medically handle the treatment.

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I am of childbearing age and have a negative pregnancy test.

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I agree to use birth control during and for 4 months after the study.

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My organ and bone marrow functions are normal based on lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.

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I need surgery to stabilize a bone before it can be treated with radiation.

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I have had allergic reactions or severe side effects to pembrolizumab or similar drugs.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am HIV-positive and on combination antiretroviral therapy.

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I have had lung inflammation treated with steroids, or I currently have lung disease.

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I have an autoimmune disease treated with immune-modifying drugs in the last 2 years.

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I have not received a live vaccine in the last 30 days.

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My cancer is pressing on my spinal cord or might soon.

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

Progression-Free Surival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: High Dose Radiation + PembrolizumabExperimental Treatment2 Interventions

* High dose radiation will be given in 3 fractions * Pembrolizumab administered intravenously on day one of each cycle.

Group II: High Dose + Low Dose Radiation + PembrolizumabExperimental Treatment2 Interventions

* High Dose radiation will be given in 3 fractions * Low Dose Radiation will be given in 2 fractions * Pembrolizumab administered intravenously on day one of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 2

~780

Pembrolizumab

2017

Completed Phase 3

~2810