Phase II Study of Sacituzumab Govitecan and Cetuximab for Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After First-Line Therapy

What this Trial Is About

Researchers are evaluating whether combining sacituzumab govitecan with cetuximab is an effective and safe treatment for people with recurrent or metastatic head and neck squamous cell cancer HNSCC who have progressed after first or second-line systemic therapy. This phase II study focuses on patients with advanced disease not suitable for curative surgery or radiation, including cancers arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. The trial is sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, combined with cetuximab, an EGFR antagonist. Treatment will be given to patients with measurable disease who have shown progression after prior therapies including anti-PDL1 agents. The study includes patients with confirmed or pending HPV status for oropharynx cancers. No placebo or masking is used in this trial. During the study, participants will be monitored up to two years to assess the objective response rate, measuring how well tumors respond to the combination therapy. Researchers will regularly evaluate disease status, blood counts, kidney and liver function, pregnancy status, and overall health. Safety and side effects will be closely monitored to understand the treatments impact. The study includes detailed eligibility and exclusion criteria to ensure participant safety and appropriateness for the therapy.

A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)