OncoMatch/Clinical Trials/NCT04620187
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
Is NCT04620187 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT04620187 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 any mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage II (WITH POSITIVE MARGINS) or III or IVA or IVB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages