OncoMatch/Clinical Trials/NCT07063212
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
Is NCT07063212 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Govitecan and Cetuximab for squamous cell carcinoma of head and neck.
Treatment: Sacituzumab Govitecan · Cetuximab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy — first line
Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial
Cannot have received: topoisomerase I inhibitor
Patients who have previously received topoisomerase I inhibitors for HNSCC
Cannot have received: EGFR antibody based therapy
Exception: previous severe infusion or allergic reactions deemed unsafe for re-challenge
Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge
Cannot have received: anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy
Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 9.0 g/dl (transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
Kidney function
Serum creatinine < 2.0 x ULN or creatinine clearance ≥ 30 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN. AST and ALT < 2.5 x ULN. Albumin ≥ 3 g/dL
Adequate hematologic function within 30 days prior to registration, defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 9.0 g/dl; Adequate renal function within 30 days prior to registration, defined as follows: Serum creatinine < 2.0 x ULN or creatinine clearance ≥ 30 ml/min; Adequate hepatic function within 30 days prior to registration, defined as follows: Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN. AST and ALT < 2.5 x ULN. Albumin ≥ 3 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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