Actively Recruiting
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-19
40
Participants Needed
7
Research Sites
130 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the head and neck from sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, or larynx
- Advanced stage IV or metastatic disease not suitable for surgery or radiation with curative intent
- Disease progression after first-line anti-PD(L)1 therapy with or without chemotherapy
- Confirmed or pending HPV status for oropharynx tumors
- Measurable disease based on RECIST v1.1 criteria
- Male or female aged 18 years or older
- ECOG Performance Status of 0 to 1
- Adequate blood counts and organ function within 30 days prior to registration
- Female participants must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential
- Male participants must agree to use contraception during the study and for five months after last dose
- Voluntary informed consent provided
You will not qualify if you...
- More than two prior systemic treatments for recurrent/metastatic disease
- Severe allergic reactions to EGFR antibody therapy deemed unsafe for retreatment
- Previous treatment with topoisomerase I inhibitors for head and neck cancer
- Suspected or confirmed Gilbert's Syndrome
- Anti-cancer therapies within two weeks before study start
- Unresolved adverse events from prior treatments (except certain neuropathy or alopecia)
- Simultaneous primary cancers other than head and neck cancer unless approved
- Recent severe heart conditions or infections requiring hospitalization
- Active central nervous system metastases or carcinomatous meningitis
- Active inflammatory bowel disease or recent gastrointestinal perforation
- Untreated or poorly controlled HIV infection or other immunodeficiency without approval
- Positive hepatitis B surface antigen or active hepatitis C infection
- Use of herbal remedies affecting major organs within 28 days before treatment
- Pregnant or breastfeeding female patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
W
Winston Wong, MD
CONTACT
L
Loren Michel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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