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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Surival
Secondary outcome measures
Abscopal Response Determined Using CT Imaging
Clinical Benefit Rate
Local Response Determined Using CT Imaging
+4 more

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
Pembrolizumab
2017
Completed Phase 2
~1950
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,388 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,682 Total Patients Enrolled
Jonathan D. Schoenfeld, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03085719 — Phase 2
Head and Neck Cancers Research Study Groups: High Dose + Low Dose Radiation + Pembrolizumab, High Dose Radiation + Pembrolizumab
Head and Neck Cancers Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03085719 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03085719 — Phase 2

Frequently Asked Questions

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

Has research been done on the effects of Pembrolizumab in other contexts?

"Currently, there are 961 examinations of Pembrolizumab being conducted with 122 studies in their culminating phase. Most tests for this treatment occur in Houston, TX; however, clinical trials can be found at 35727 different sites worldwide."

Answered by AI

Are there still opportunities to enroll in this research endeavor?

"Indeed, clinicaltrials.gov reveals that this trial is now searching for participants. It was initially revealed on June 30th 2017 and edited as recently as November 28th 2022. 26 individuals are being recruited from 1 medical site."

Answered by AI

Are there any afflictions that Pembrolizumab has been demonstrated to alleviate?

"Pembrolizumab is commonly used to combat malignant neoplasms, and can also be a potential treatment for those with unresectable melanoma, microsatellite instability high, or are dealing with disease progression after chemotherapy."

Answered by AI

What is the upper limit of subjects taking part in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical trial is in the recruitment phase, which was first initiated June 30th 2017 and last updated November 28th 2022. 26 patients are anticipated to be enrolled at a single research centre."

Answered by AI

Does Pembrolizumab pose any risks to the individuals taking it?

"The security of pembrolizumab has been evaluated by the Power team and given a score of 2 as this is still in phase two. Thus far, safety data exists but not efficacy information."

Answered by AI
~2 spots leftby Mar 2025