Actively Recruiting
A Phase II Study of Sacituzumab Govitecan Combined With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer After First-Line Therapy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-19
40
Participants Needed
7
Research Sites
N/A
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
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-PD(L)1 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 treatment's impact. The study includes detailed eligibility and exclusion criteria to ensure participant safety and appropriateness for the therapy.
CONDITIONS
Brief 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 curative surgery or radiation.
- Disease progression after first line anti-PD(L)1 therapy with or without chemotherapy.
- HPV status confirmed or in progress for oropharynx cancers.
- Measurable disease per RECIST v1.1 criteria.
- Age 18 years or older at consent.
- ECOG Performance Status 0 to 1.
- Adequate blood, kidney, and liver function within 30 days prior to registration.
- Women must not be pregnant or breastfeeding and use effective contraception if of childbearing potential.
- Men must agree to use contraception during and for five months after treatment.
- Provide voluntary informed consent.
You will not qualify if you...
- More than two prior systemic treatments for recurrent/metastatic disease.
- Severe allergic reactions to EGFR antibody therapy.
- Prior treatment with topoisomerase I inhibitors for head and neck cancer.
- Diagnosis or suspicion of Gilbert's Syndrome.
- Anti-cancer treatment within two weeks before study start.
- Unresolved side effects from previous treatments except mild neuropathy or alopecia.
- Other active cancers unless approved by investigator.
- Severe heart, lung, hepatic, or infection-related conditions.
- Active brain metastases or carcinomatous meningitis.
- Active inflammatory bowel disease or recent gastrointestinal perforation.
- Untreated or poorly controlled HIV or other immunodeficiency.
- Positive hepatitis B or active hepatitis C infection.
- Use of herbal remedies affecting major organs within 28 days before treatment.
- Pregnant or breastfeeding women or those planning pregnancy during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive Sacituzumab Govitecan combined with Cetuximab as part of their treatment for recurrent or metastatic head and neck squamous cell carcinoma after progression following first-line therapy.
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
L
Loren Michel, MD
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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