Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin
Greg Durm, MD
Primary Investigator
Brief description of study
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Head and Neck Cancer who cannot take the drug cisplatin
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Age: Between 18 Years - 100 Years
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Gender: All
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or carcinoma of unknown head/neck primary within 60 days prior to step 1 registration; submission of hematoxylin and eosin (H&E) stained slides and formalin-fixed and paraffin-embedded (FFPE) tissue block (or punch biopsy of FFPE block) to the biospecimen bank at University of California, San Francisco (UCSF) for central review for oropharyngeal and unknown primaries and for p16 analysis for all other non- oropharyngeal primaries is mandatory for all patients; investigators should check with their pathology department regarding release of biospecimens before approaching patients about participation in the trial; for oropharyngeal and unknown primaries, submission of H&E and p16 stained slides to the biospecimen bank at UCSF for central review is also required prior to step 2 registration
- Patients must have stage III-IVB head and neck squamous cell carcinoma (HNSCC) (American Joint Committee on Cancer [AJCC] seventh [7th] edition) based on the following minimum diagnostic workup within 60 days prior to step 1 registration:
- General history and physical examination by a radiation oncologist, medical oncologist, and/or ear, nose and throat (ENT) or head & neck surgeon
- For larynx, hypopharynx, and base of tongue primaries, a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is required, unless the patient cannot tolerate or refuses
- Imaging of the head and neck with a neck CT or magnetic resonance imaging (MRI) (with contrast, unless contraindicated) or PET/CT (with contrast, unless contraindicated)
- Chest imaging: chest CT with and without contrast (unless contraindicated) or PET/CT
For a full list of participation criteria, please visit clinicaltrials.gov.
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