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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

Must not have

Patients must not have prior head and neck radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from step 2 randomization to disease progression or death, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

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

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I have never had radiotherapy for head or neck cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from step 2 randomization to disease progression or death, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from step 2 randomization to disease progression or death, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from step 2 randomization to disease progression or death, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Incidence of adverse events (AE)

Progression-free survival

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Cisplatin

2013

Completed Phase 3

~3120

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160