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

Summary

This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Timeline

Start

2019-06-17

Primary completion

2025-02-26

Completion

2028-12-01

Outcome

Met primary endpoint

paper Avelumab + cetuximab significantly improved PFS versus avelumab (median, 11.1 [7.6-not reached (NR)] v 3.0 months [2.7-13.6] hazard ratio, 0.48 [95% CI, 0.23 to 0.97], P = .018. PMID 40448574 ↗

Publications

• Zandberg DP, Allred JB, Rosenberg AJ, Kaczmar JM, Swiecicki P, Julian RA, Poklepovic AS, Bauman JR, Phan MD, Saba NF, Rivera E, Rowland K, Davar D, Cordes J, Ho AL, Zhang M, Berg SA, Munster PN, Schwartz GK. Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma. J Clin Oncol. 2025 Jul 20;43(21):2398-2408. doi: 10.1200/JCO-25-00759. Epub 2025 May 31.

Drugs

Indications