A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

Completed · Phase 1

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

Key facts

Study ID

NCT02262741

Run by

MedImmune LLC

People needed

71

Starts

2014-10-15

Expected to finish

2017-09-21

Last updated by the study team

2017-10-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects
• 18 years and older
• Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
• Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
• Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.

You may not qualify if…

• Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
• Concurrent or prior use of immunosuppressive medication within 14 days
• Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Orlando, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Fairway, Kansas, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Fairfax, Virginia, United States
• Research Site — London, Ontario, Canada
• Research Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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