Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

Completed · Phase 3

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Key facts

Study ID

NCT02551159

Run by

AstraZeneca

People needed

823

Starts

2015-10-15

Expected to finish

2021-05-21

Last updated by the study team

2021-10-13

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years at the time of screening
• Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
• A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
• No prior systemic chemotherapy for recurrent or metastatic disease
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• No prior exposure to immune-mediated therapy,

You may not qualify if…

• Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
• Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
• Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis

Where it is running

• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Graz, Austria
• Research Site — Innsbruck, Austria
• Research Site — Linz, Austria
• Research Site — Vienna, Austria
• Research Site — Brussels, Belgium
• Research Site — Brussels, Belgium
• Research Site — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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