Study on Sacituzumab Govitecan and Cetuximab for Head and Neck Squamous Cell Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT07063212
This clinical trial is exploring whether a combination of the drugs sacituzumab govitecan and cetuximab is a safe and effective treatment for people with head and neck squamous cell cancer that has come back or spread to other parts of the body.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to determine if using sacituzumab govitecan together with cetuximab can help treat head and neck squamous cell cancer (HNSCC) that has returned or spread. Researchers want to find out if this combination is both safe and effective for patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with squamous cell carcinoma of the head and neck, including areas like the sinuses, nasal cavity, mouth, throat, and voice box.
- Have advanced cancer that cannot be cured with surgery or radiation.
- Cancer has progressed after first-line treatment with anti-PD(L)1 therapy, with or without chemotherapy.
- HPV status for throat cancer must be confirmed or tested during the study.
- Have measurable cancer based on specific criteria.
- Be 18 years or older.
- Be in good overall health with a performance status of 0 or 1.
- Have adequate blood cell counts and organ function based on recent tests.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control during and after the study.
- Men must agree to use contraception and not donate sperm during and after the study.
- Must provide informed consent to participate.
Exclusion Criteria
- Have received more than two prior treatments for recurrent/metastatic cancer.
- Have had severe allergic reactions to similar treatments.
- Have previously received certain cancer drugs for HNSCC.
- Have a diagnosis of Gilbert's Syndrome.
- Have had recent cancer treatments or not fully recovered from previous treatments.
- Have other active cancers unless approved by the study doctor.
- Have serious health conditions like recent heart problems or severe infections.
- Have active brain cancer or untreated brain metastases.
- Have certain immune system disorders or infections like HIV or hepatitis.
- Use herbal remedies that may interfere with treatment.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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