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

Trisha Wise-Draper

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Cancer; Recurrent Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Cancer

Treatments: Drug: Durvalumab; Drug: Cetuximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03691714

UCCI-HN-17-02

EAR-17-12765 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Durvalumab and Cetuximab

Experimental group

Description:

Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance

Treatment:

Drug: Cetuximab

Drug: Durvalumab