OncoMatch/Clinical Trials/NCT04620187
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
Is NCT04620187 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ado-trastuzumab (T) emtansine (T-DM1) and Standard of Care Chemotherapy for salivary gland cancer.
Treatment: Ado-trastuzumab (T) emtansine (T-DM1) · Standard of Care Chemotherapy — This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 2+ or 3+)
Tumor HER2 expression staining intensity of 2 or 3+ by IHC
Required: HER2 (ERBB2) amplification (FISH HER2/CEP 17 ratio ≥ 2.0 or HER2 mean copy number ≥ 4.0)
HER2 amplification as determined by FISH (HER2/CEP 17 ratio greater than or equal to 2.0 or HER2 mean copy number greater than or equal to 4.0)
Required: HER2 (ERBB2) any mutation
HER2 or ERBB2 mutated on tumor genomic sequencing assay (see Section 9.1 for permitted HER2 mutations)
Disease stage
Required: Stage II (WITH POSITIVE MARGINS), III, IVA, IVB
Excluded: Stage I, IVC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Cannot have received: chemotherapy
Cannot have received: her2-targeted therapy
Lab requirements
Blood counts
leukocytes ≥ 3,000/mcL; absolute neutrophil count ≥ 1,000/mcL; hemoglobin ≥ 9.0 g/dL; platelets ≥ 100,000/mcL
Kidney function
creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Liver function
total bilirubin ≤ 2.0 g/dL; AST(SGOT)/ALT(SGPT) ≤ 2.5× institutional upper limit of normal
Cardiac function
LVEF ≥ 50% by echocardiogram or MUGA scan within 1 month prior to study registration
Participant must have normal organ and marrow function as defined below within 14 days prior to study registration ... Assessment of cardiac function ... LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Chicago · Chicago, Illinois
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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