Recruiting

Phase 2

T-DM1Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04620187

Conditions

Salivary Gland Cancer

HER2 Gene Mutation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ado-trastuzumab (T) emtansine (T-DM1)

Standard of Care Radiotherapy

Standard of Care Chemotherapy

Study Details

Brief summary:

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.

Conditions

Salivary Gland Cancer

HER2 Gene Mutation

Study ID

NCT04620187

Start date

Dec 24, 2020

Status verified date

Apr, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer

Participants will undergo standard of care surgery followed by standard of care radiation and chemotherapy with the addition of T-DM1.

Study cycles are 21 days (3 weeks):

Participants will be given the study treatment T-DM1 at a predetermined dose (3.6 mg/kg) intravenously once (1x) every 3 weeks for up to 52 weeks (or about 1 year).
Participants will be given standard of care radiation and chemotherapy

Radiation will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1
Chemotherapy (cisplatin 40 mg/m2 intravenously or carboplatin AUC 2 intravenously) will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1

Participants will be followed for 2 years.

Interventions

Ado-trastuzumab (T) emtansine (T-DM1)

Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)

Standard of Care Radiotherapy

Radiotherapy to shrink or kill tumors

Standard of Care Chemotherapy

Intravenous injection

Primary outcome measure

2 Year Disease-free survival (DFS) Rate [ Time Frame: Time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause assessed up to 36 months ]

Central Contacts and Locations

Central contacts

Glenn J Hanna, MD

617-632-3090 glenn_hanna@dfci.harvard.edu

Locations

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Conor Steuer, MD

404-778-5378 csteuer@emory.edu

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Alexander T Pearson, MD, PhD

855-702-8222 apearson5@medicine.bsd.uchicago.edu

Cancer Clinical Trials Office

855-702-8222 cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Alexander T Pearson, MD, PhD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Glenn J Hanna, MD

617-632-3090 glenn_hanna@dfci.harvard.edu

Principal Investigator:

Glenn J Hanna, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Glenn J. Hanna, MD

617-632-3090 glenn_hanna@dfci.harvard.edu

Principal Investigator:

Glenn J. Hanna, MD

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Alan L Ho, MD, PhD

833-637-1274

Principal Investigator:

Alan L Ho, MD, PhD

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Alan L Ho, MD, PhD

844-665-7394

Principal Investigator:

Alan L Ho, MD, PhD

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Alan L Ho, MD, PhD

551-751-1007

Principal Investigator:

Alan L Ho, MD, PhD

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Alan L Ho, MD, PhD

833-637-1274

Principal Investigator:

Alan L Ho, MD, PhD

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Alan L Ho, MD, PhD

914-893-4461

Principal Investigator:

Alan L Ho, MD, PhD

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Alan L Ho, MD, PhD

833-637-1274

Principal Investigator:

Alan L Ho, MD, PhD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Alan L Ho, MD, PhD

646-733-4430

Principal Investigator:

Alan L Ho, MD, PhD

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Alan L Ho, MD, PhD

516-564-2022

Principal Investigator:

Alan L Ho, MD, PhD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Jay Liao, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

Salivary Gland Cancer
HER2 Gene Mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-04-13.