Health Trials

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

ConditionsSquamous Cell Carcinoma of Head and NeckSinus CancerNasal Cavity CancerOral Cavity CancerOropharynx CancerHypopharynx CancerLarynx CancerOral Squamous Cell CarcinomaOropharynx Squamous Cell CarcinomaHypopharynx Squamous Cell CarcinomaLarynx Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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

Qualifiers

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.

Disqualifiers

Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent/metastatic setting.

Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and/or consultation with allergy/immunology.

Patients who have previously received topoisomerase I inhibitors for HNSCC

Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome

Trial design

Treatments tested in this trial

  • Sacituzumab Govitecan
  • Cetuximab

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov