Recurrent Head and Neck CancerPhase 2NCT03691714

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

A Phase 2 study testing Durvalumab and Cetuximab in people with Recurrent Head and Neck Cancer and Head and Neck Cancer, run by University of Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms
What is being tested?: Durvalumab and Cetuximab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2018to 1 Dec 2024
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Body weight > 30 kg
Histologically or cytologically confirmed recurrent or metastatic HNSCC
Not considered a candidate for other curative therapy (i.e. surgery/RT)
Documented progression of disease after receiving platinum based regimen
ECOG performance status 0-2

Who cannot join

Nasopharyngeal and salivary gland tumors
Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Health
Cincinnati, Ohio, 45219

Other trials in United States

About this study

Official title: An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Read the detailed description

This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Conditions: Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms, Metastatic Cancer
Being tested: Durvalumab, Cetuximab
Medical subject headings: Head and Neck Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Also called MEDI4736
Two hour infusion
CetuximabDrug
Two hour infusion for loading dose followed by weekly one hour infusion

Study groups in NCT03691714
Study group	Role	What they receive
Durvalumab and Cetuximab	Experimental	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 Receives: Drug: Durvalumab; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months.

Secondary outcomes (4)

Treatment Related Adverse Events
Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).
Measured: From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 months.
Disease Control Rate
Combined complete response, partial response, and stable disease
Measured: 6 months
Progression-free Survival
Imaging review using RECIST 1.1 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 24 months
Overall Survival
Date of on treatment to date of death
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 20181 Dec 2024

First posted2 Oct 2018
Study start23 Oct 2018
Primary completion1 Dec 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Head and Neck CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03691714
Sponsor's protocol ID: UCCI-HN-17-02
Other IDs: EAR-17-12765
Status last verified: Jun 2026
First submitted: 28 Sep 2018
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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