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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms, Metastatic Cancer

Intervention / Treatment
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* Drug: Durvalumab
* Drug: Cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Nasopharyngeal and salivary gland tumors Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durvalumab and Cetuximab<br>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 | Drug: Durvalumab<br>* Two hour infusion<br>* Other names: MEDI4736;Drug: Cetuximab<br>* Two hour infusion for loading dose followed by weekly one hour infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Imaging review using RECIST 1.1 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Percentage of adverse events using CTCAE v 5.0 | 24 months | 
| Disease control rate | Combined complete response, partial response, and stable disease | 6 months | 
| Progression-free survival | Imaging review using RECIST 1.1 | 24 months | 
| Overall survival | Date of on treatment to date of death | 24 months | 
| Duration of response | Date of initial response to progressive disease | 24 months |