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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
Adverse events
Disease control rate
Duration of response
+2 more

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
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,287 Previous Clinical Trials
288,620,114 Total Patients Enrolled
Shuchi GulatiLead Sponsor
Trisha Wise-DraperLead Sponsor
5 Previous Clinical Trials
196 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03691714 — Phase 2
Head and Neck Cancers Research Study Groups: Durvalumab and Cetuximab
Head and Neck Cancers Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT03691714 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03691714 — Phase 2
~2 spots leftby Dec 2024
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