Using T-DM1 with chemotherapy and radiation for HER2-positive salivary gland cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the safety and effectiveness of ado-trastuzumab emtansine (T-DM1) in combination with standard chemoradiation for patients with HER2-positive salivary gland carcinoma following surgery. The study aims to evaluate the effectiveness of T-DM1 in preventing cancer recurrence and its safety profile. Participants will receive T-DM1 for up to one year after surgery, with follow-up evaluations conducted over three years. The trial is open-label and non-randomized, allowing for a comprehensive assessment of treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject must have histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced salivary gland carcinoma (including any histologic subtype), as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition.
* Willing to provide tissue from a diagnostic biopsy or at the time of cancer resection, and blood samples before, during, and after treatment.
* HER2 positive disease as defined by any of the following:

  * Tumor HER2 expression staining intensity of 2 or 3+ by IHC (from either a preoperative biopsy or resection specimen at the time of oncologic surgery)
  * 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)
  * HER2 or ERBB2 mutated on tumor genomic sequencing assay (see Section 9.1 for permitted HER2 mutations)
* Age 18 years or older
* ECOG performance status ≤ 1 (Karnofsky ≥ 60%, see Appendix A)
* Participant must have normal organ and marrow function as defined below within 14 days prior to study registration:

  * leukocytes ≥ 3,000/mcL
  * absolute neutrophil count ≥ 1,000/mcL
  * hemoglobin ≥ 9.0 g/dL
  * platelets ≥ 100,000/mcL
  * total bilirubin ≤ 2.0 g/dL
  * AST(SGOT)/ALT(SGPT) ≤ 2.5× institutional upper limit of normal
  * creatinine within normal institutional limits OR
  * creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
* Serum calcium (corrected for albumin value), magnesium, and potassium levels within normal limits per institutional standards.
* Assessment of cardiac function either by an echocardiogram or a multi-gated acquisition (MUGA) scan prior to the therapy initiation, with a baseline left systolic ventricular ejection fraction (LVEF) ≥ 50% within 1 month prior to study registration.
* Ability to understand and the willingness to sign a written informed consent document.
* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of T-DM1. "Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.

Exclusion Criteria:

* Patient with AJCC 2017 8th edition stage I or stage IVC (metastatic) disease, or unresectable disease.
* Subject who has had prior radiation and/or chemotherapy for head and neck cancer.
* Any history of prior HER2 directed therapy.
* Active or uncontrolled infection.
* Pregnant or lactating women.
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Has a known additional malignancy that is progressing or requires active treatment.

Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.

Where it's running

• Winship Cancer Institute, Emory University
  Atlanta, Georgia, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Memorial Sloan Kettering Basking Ridge
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth
  Middletown, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Glenn J Hanna, MD — Dana-Farber Cancer Institute
• Study coordinator: Glenn J Hanna, MD
• Email: glenn_hanna@dfci.harvard.edu
• Phone: 617-632-3090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.