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Alliance A091802

Trial Overview

Official Title

Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer

Study Purpose

To test the good and bad effects of the combined treatment, using the drugs cetuximab and avelumab as well as avelumab by itself.

Diagnosis

Advanced Squamous Cell Carcinoma of the skin

Eligibility

Biopsy-proven advanced cutaneous squamous cell carcinoma.

Advanced disease is defined as either metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma not amenable to curative surgical resection, or the patient declines surgical resection

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• Group 1: Will get the study drug avelumab through a vein in arm every two weeks for up to two years.

• Group 2: Will get the study drug avelumab through a vein in arm every two weeks plus cetuximab through a vein in arm every week. Will receive avelumab and cetuximab together on day 1 and 15 of each cycle. Will get only cetuximab on day 8 and 22 of each cycle. Each cycle lasts 28 days. This will last for 1 year (12 cycles). Starting in year 2 (cycle 13) patients will receive avelumab alone every two weeks for an additional year.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Phase
Phase II
Methodist Health System Trial Code
A091802
Related Specialties