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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 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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,750 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

Frequently Asked Questions

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

Has the Durvalumab undergone FDA evaluation and certification?

"Durvalumab scored a 2 on our team's risk assessment scale due to there being evidence of its safety, yet no data implying efficacy."

Answered by AI

Has Durvalumab's efficacy been validated in any other investigations?

"Presently, there are 452 clinical trials with Durvalumab as the subject. Of those active studies, 81 are in their third phase of testing. Though based primarily in Hobart Tasmania, 18238 locations worldwide have clinical trials for this medication underway."

Answered by AI

How many participants is the team enrolling for this clinical experiment?

"No, this particular research initiative is no longer looking for volunteers. It was posted on October 23rd 2018 and the information has been last updated on October 3rd 2022. Despite this study's closure, there are currently 2248 trials accepting participants with head neoplasms and 452 studies involving Durvalumab actively recruiting patients."

Answered by AI

What clinical applications is Durvalumab most often deployed for?

"Durvalumab is a viable therapeutic option for those with metastatic squamous cell carcinoma of the head and neck (hnscc) or regular squamous cell carcinoma."

Answered by AI

Is registration currently available for this trial?

"This clinical trial, which was first published on October 23rd 2018 and last updated on October 3rd 2022, is not presently enrolling new patients. However, there are 2700 other trials actively recruiting individuals right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Trisha Wise-Draper 2018. "Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03691714.

All > Head And Neck Cancer > Squamous Cell Carcinoma