NCT02938273

Bioimmunoradiotherapy (Cetuximab/RT/Avelumab)

Bioimmunoradiotherapy (BIR) With Concurrent Avelumab, Cetuximab and Radiotherapy as First Line Treatment in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. A Feasibility Study in Patients Unfit for Cisplatin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase IB trial with Bioimmunoradiotherapy, i.e. concurrent radiotherapy with intravenous administration of cetuximab and avelumab followed by avelumab maintenance therapy in patients with locally advanced head and neck cancer, unfit for cisplatin.

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
DRUG	avelumab	Avelumab10 mg/kg i.v. at day -7, 7, 21,35 + maintenance therapy i.e avelumab10 mg/kg i.v. every 2 weeks for 6 months
RADIATION	radiotherapy	5 times a week, 7 weeks, total dose 70 Gy
DRUG	cetuximab	loading dose 400 mg/m2 i.v. day -7, 250 mg/m2 i.v weekly wk 1-7

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-06-26
• Completion: 2019-09-30
• First posted: 2016-10-19
• Last updated: 2019-12-11

Locations

1 site across 1 country: Netherlands