NCT03691714

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

An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Trisha Wise-Draper · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Recurrent Head and Neck Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Two hour infusion
DRUG	Cetuximab	Two hour infusion for loading dose followed by weekly one hour infusion

Timeline

• Start date: 2018-10-23
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2018-10-02
• Last updated: 2023-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study