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

Investigating Radiation Therapy with a Treatment Being Tested for Head and Neck Cancer

Recruiting
18 years - 100 years
All
1 Location

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
  • Age: 18 years - 100 years
  • 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.

Updated on 19 Feb 2024. Study ID: 1804228236

This study investigates the effects of combining usual radiation therapy with an investigational medication compared to the usual therapy of radiation plus cetuximab. The study focuses on patients with head and neck cancer who are unable to take the drug cisplatin. Head and neck cancer includes cancers that start in the mouth, nose, throat, or nearby areas. The investigational medication is being tested to see if it works better or worse than the current treatment.

Participants will undergo procedures such as radiation therapy and will receive either the investigational medication or cetuximab. The study will monitor the effects of these treatments, looking for any benefits or side effects. Participants will be regularly evaluated to assess the treatment's impact on their cancer.

  • Who can participate: Adults with a confirmed diagnosis of untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or unknown primary head/neck cancer may participate. They must have stage III-IVB head and neck squamous cell carcinoma and be unable to take cisplatin.
  • Study details: Participants will receive radiation therapy along with either the investigational medication or cetuximab. A placebo is not used in this study.

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