Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin. SECONDARY OBJECTIVES: I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be ...

PRIMARY OBJECTIVE: I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin. SECONDARY OBJECTIVES: I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially). II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years. EXPLORATORY OBJECTIVES: I. Prospectively test the ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck (SCCHN) patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin. II. To assess the PFS and OS of patients with combined positive score (CPS) <1%, >1%, and > 20%. III. Compare the predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS. OUTLINE: Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 104 weeks, and paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes once weekly (QW) for up to 24 weeks. Treatment continuous in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 14 days and then every 12 weeks.

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