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New treatment option for Salivary Gland Cancer
Official title Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
ClinicalTrials.gov ID: NCT04620187
What this study is testing
What is Ado-trastuzumab (T) emtansine (T-DM1)?
Ado-trastuzumab (T) emtansine (T-DM1) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for salivary gland cancer.
Also referred to as Kadcyla.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must have histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced...
- 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)
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.