Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study

Official Summary

This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 108 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo biopsy
• PROCEDURE: Biospecimen Collection — Undergo collection of blood samples
• DRUG: Carboplatin — Given IV
• DRUG: Carboplatin — Given carboplatin
• BIOLOGICAL: Cemiplimab — Given IV

Primary Outcomes

• Event free survival (EFS) (From randomization to first occurrence of progression of disease or death, assessed up to 5 years)

Secondary Outcomes

• Overall response rate (ORR) (Up to 5 years)
• Incidence of adverse events (AEs) associated with neoadjuvant therapy (NAT) (Up to 5 years)
• Changes in T-cell clonality/diversity (Up to 5 years)
• Organ preservation rates (Up to 5 years)
• Overall survival (OS) (From the start of NAT to death, assessed up to 5 years)

Trial Locations

• Ohio State University Comprehensive Cancer Center LAO, Columbus, Ohio, United States

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