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PD-1 Inhibitor

Radiation + Immunotherapy for Head and Neck Cancer

Phase 3

Recruiting

Led By David J Sher

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patient must have ECOG performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from step 2 randomization to death from any cause, assessed up to 3 years

Awards & highlights

Study Summary

This trial is testing a new way to treat metastatic head and neck cancer with pembrolizumab and radiation therapy.

Who is the study for?

This trial is for adults with metastatic squamous cell carcinoma of the head and neck. Participants must be in good physical condition, have measurable disease, and not have had prior head and neck radiotherapy. They should not be pregnant or breastfeeding, must agree to use contraception, and cannot have an active autoimmune disease requiring recent systemic treatment.Check my eligibility

What is being tested?

The study compares two approaches: pembrolizumab combined with radiation therapy versus standard therapy (pembrolizumab alone) after initial chemoimmunotherapy. The goal is to see if adding radiation improves outcomes for patients with this type of cancer that has spread from its original site.See study design

What are the potential side effects?

Potential side effects include reactions related to immunotherapy such as fatigue, skin rash, diarrhea; complications from chemotherapy like nausea; and typical effects of radiation such as skin irritation or difficulty swallowing depending on the area treated.

Eligibility Criteria

Inclusion Criteria

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

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My hepatitis B virus load is undetectable with treatment.

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I am able to get out of my bed or chair and move around.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have received chemoimmunotherapy.

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I had hepatitis C but have been treated and cured.

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I am 18 years old or older.

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My cancer started in my mouth or throat, has spread, and is still active.

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I have finished 3 rounds of chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from step 2 randomization to death from any cause, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from step 2 randomization to death from any cause, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from step 2 randomization to death from any cause, assessed up to 3 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

Overall survival

Secondary outcome measures

Incidence of adverse events (AE)

Progression-free survival

Time to treatment failure

Other outcome measures

Early change in the FACT-HN TOI

Incidence of tracheostomy and/or gastrostomy

Nadir of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator score

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm T (pembrolizumab, chemotherapy)Experimental Treatment5 Interventions

Patients receive pembrolizumab IV with carboplatin IV and paclitaxel IV, or with cisplatin IV and fluorouracil IV, or with carboplatin IV and fluorouracil IV on study.

Group II: Arm A (pembrolizumab and radiation)Experimental Treatment10 Interventions

Patients receive one cycle of pembrolizumab IV with carboplatin IV and paclitaxel IV, or with cisplatin IV and fluorouracil IV, or with carboplatin IV, and fluorouracil IV on study and then receive pembrolizumab IV with radiation therapy on study. Patients also undergo CT, PET/CT, and/or MRI throughout the trial.

Group III: Arm S (no intervention)Active Control1 Intervention

Patients proceed directly to Step II.

Group IV: Arm B (pembrolizumab monotherapy)Active Control9 Interventions

Patients receive one cycle of pembrolizumab IV with carboplatin IV and paclitaxel IV, or with cisplatin IV and fluorouracil IV, or with carboplatin IV, and fluorouracil IV on study and then receive pembrolizumab IV monotherapy on study. Patients also undergo CT, PET/CT, and/or MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

Pembrolizumab

2017

Completed Phase 2

~2010

Radiation Therapy

2017

Completed Phase 3

~7250

Cisplatin

2013

Completed Phase 3

~1940

Computed Tomography

2017

Completed Phase 2

~2720

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Fluorouracil

2014

Completed Phase 3

~11540

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,632 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,151 Total Patients Enrolled

David J SherPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Frequently Asked Questions

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

How many physical sites have been set up to conduct this research endeavor?

"This clinical trial is seeking participants at Carle Physician Group-Effingham in Effingham, Iowa; Carle Physician Group-Mattoon/Charleston in Mattoon, Minnesota; and the renowned Carle Cancer Center in Urbana, New york. Additionally, there are 20 other locations listed on clinicialtrials.gov where individuals can sign up for this study."

Answered by AI

Are there any vacant positions available in this research project?

"The information posted to clinicaltrials.gov illustrates that this trial is currently looking for participants, having been initially published 8th June 2023 and recently updated 10th October 2023."

Answered by AI

Has the Arm A combination of pembrolizumab and radiation been ratified by the FDA?

"The safety of Arm A (pembrolizumab and radiation) was rated a 3, as there is prior evidence that suggests efficacy and multiple rounds of research which support its safety."

Answered by AI

How many volunteers are involved in this trial's research?

"This clinical trial necessitates the involvement of 290 qualified individuals. Those interested can find spots to participate at Carle Physician Group-Effingham in Effingham, Iowa and Carle Physician Group-Mattoon/Charleston in Mattoon, Minnesota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck

2023. "Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721755.

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