Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Sponsor: Trisha Wise-Draper

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03691714

This study evaluates the efficacy and safety of combining durvalumab with cetuximab in treating recurrent or metastatic head and neck cancer. Eligible participants must weigh over 30 kg, have confirmed HNSCC, and show disease progression post-platinum therapy. Interventions include durvalumab and cetuximab infusions, with specific dosing schedules.

Patient Parameters

Program Overview

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

Description

This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Eligibility Criteria

Inclusion Criteria

  • Body weight > 30 kg
  • Histologically or cytologically confirmed recurrent or metastatic HNSCC
  • Not considered a candidate for other curative therapy (i.e. surgery/RT)
  • Documented progression of disease after receiving platinum based regimen
  • ECOG performance status 0-2

Exclusion Criteria

  • Nasopharyngeal and salivary gland tumors
  • Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

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