A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
Trial Parameters
Brief Summary
The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and/or metastatic head and neck squamous cell cancer (HNSCC).
Eligibility Criteria
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion. * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and/or radiation based approaches * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I. * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if