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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

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18 years and older
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  • Technical description (Original)

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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Study details
    Head and Neck Cancer who cannot take the drug cisplatin

TX10565

19 February 2024

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