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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shuchi Gulati; Trisha Wise-Draper
• Collaborator: AstraZeneca
• Treatments: Antibodies, Monoclonal; Cetuximab; Durvalumab

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.