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



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:October 23, 2018
End Date:October 2022
Contact:UC Cancer Institute Clinical Trials Office
Email:cancer@uchealth.com
Phone:513-584-7698

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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)

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.

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.

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.
We found this trial at
1
site
Cincinnati, Ohio 45267
Principal Investigator: Trisha Wise, MD, PhD
Phone: 513-584-7698
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mi
from
Cincinnati, OH
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