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Monoclonal Antibodies

Cetuximab + Pembrolizumab for Head and Neck Cancer

Phase 3

Recruiting

Led By Siddharth Sheth

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Histologically confirmed diagnosis of head and neck squamous cell carcinomas (HNSCC)

Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial compares adding a drug called cetuximab to pembrolizumab versus using pembrolizumab alone to treat patients with head and neck cancer that has come back or spread to

Who is the study for?

This trial is for adults with head and neck squamous cell carcinoma that has returned or spread after initial treatment. Eligible patients must have a specific protein on their tumor cells, haven't been treated in the recurrent/metastatic setting, and should not have progressed during prior anti-cancer therapies if received more than 6 months ago.

What is being tested?

The study compares adding Cetuximab (a monoclonal antibody targeting EGFR) to Pembrolizumab (another type of immunotherapy) versus using Pembrolizumab alone. The goal is to see if the combination works better for treating recurrent or metastatic head and neck cancer.

What are the potential side effects?

Potential side effects include allergic reactions, skin rash, infusion-related reactions from Cetuximab; fatigue, itching, diarrhea from Pembrolizumab; plus both can cause immune system related side effects affecting lungs, liver, intestines.

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 of head and neck cancer known as squamous cell carcinoma.

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My oropharyngeal cancer is HPV-negative.

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My hepatitis B virus load is undetectable with treatment.

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I have never had myocarditis.

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I am 18 years old or older.

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I have not been treated for my cancer that has returned or spread and cannot be cured by surgery or radiation.

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I am not pregnant or breastfeeding.

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My cancer is in my mouth, throat, voice box, or the area below my pharynx.

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I have not received treatment for cancer that has returned or spread.

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I have no severe allergies to pembrolizumab or cetuximab.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My condition did not improve after platinum-based chemotherapy.

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My tumor is PD-L1 positive with a score of 1 or higher.

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I have never had pneumonitis or any similar lung condition.

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I can perform daily activities with minimal assistance.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival

Secondary study objectives

Confirmed response rate

Duration of response

Incidence of adverse events

+2 more

Other study objectives

Estimates of median OS by ethnicity

Estimates of median OS by race

Estimates of median OS by sex

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 (cetuximab, pembrolizumab)Experimental Treatment6 Interventions

Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.

Group II: Arm 1 (pembrolizumab)Active Control5 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180