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Monoclonal Antibodies

Durvalumab + Cetuximab for Head and Neck Squamous Cell Carcinoma

Phase 2

Waitlist Available

Led By Trisha Wise, MD, PhD

Research Sponsored by Shuchi Gulati

Eligibility Criteria Checklist

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

Must have

Documented progression of disease after receiving platinum based regimen

Not considered a candidate for other curative therapy (i.e. surgery/RT)

Must not have

Nasopharyngeal and salivary gland tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for head and neck cancer. Durvalumab and cetuximab will be given to participants to see if it is effective.

Who is the study for?

This trial is for adults over 30 kg with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who aren't eligible for curative treatments like surgery. They must have had disease progression after platinum-based therapy and be in a relatively stable condition (ECOG 0-2). Those with nasopharyngeal/salivary gland tumors or previous treatment with both immunotherapy drugs and Cetuximab can't participate.

What is being tested?

The study is testing the effectiveness of combining two anti-cancer drugs, durvalumab (the study drug) and cetuximab, as a treatment option for patients with metastatic or recurrent head and neck cancer. Participants will receive both medications during the trial.

What are the potential side effects?

Potential side effects from durvalumab include immune-related reactions affecting organs, infusion-related symptoms, fatigue, skin rash, and increased risk of infections. Cetuximab may cause skin reactions, low magnesium levels, infusion reactions including chills and fever.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has worsened after treatment with platinum-based drugs.

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I am not eligible for surgery or radiation to cure my condition.

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My body weight is over 30 kg.

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My cancer in the head or neck area has returned or spread.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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My cancer is in the nasopharynx or salivary glands.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate

Secondary study objectives

Adverse events

Disease control rate

Duration of response

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Durvalumab and CetuximabExperimental Treatment2 Interventions

Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Durvalumab

2017

Completed Phase 2

~3750