Salivary Gland CancerPhase 2NCT04620187
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
A Phase 2 study testing Ado-trastuzumab (T) emtansine (T-DM1) in people with Salivary Gland Cancer and HER2 Gene Mutation, run by Dana-Farber Cancer Institute at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Cancer, HER2 Gene Mutation
- What is being tested?
- Ado-trastuzumab (T) emtansine (T-DM1)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 13 sitesUnited States
- Study dates
- 24 Dec 2020to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 22Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Conor Steuer, MD, 404-778-5378, csteuer@emory.edu
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Alan L Ho, MD, PhD, 833-637-1274
Alan L Ho, MD, PhD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Glenn J Hanna, MD, 617-632-3090, glenn_hanna@dfci.harvard.edu
Glenn J Hanna, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Glenn J. Hanna, MD, 617-632-3090, glenn_hanna@dfci.harvard.edu
Glenn J. Hanna, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Alexander T Pearson, MD, PhD, 855-702-8222, apearson5@medicine.bsd.uchicago.edu
Cancer Clinical Trials Office, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Alan L Ho, MD, PhD, 833-637-1274
Alan L Ho, MD, PhD
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Alan L Ho, MD, PhD, 914-893-4461
Alan L Ho, MD, PhD
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Alan L Ho, MD, PhD, 844-665-7394
Alan L Ho, MD, PhD
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Alan L Ho, MD, PhD, 551-751-1007
Alan L Ho, MD, PhD
- Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Alan L Ho, MD, PhD, 833-637-1274
Alan L Ho, MD, PhD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Alan L Ho, MD, PhD, 646-733-4430
Alan L Ho, MD, PhD
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Jay Liao, MD
Jay Liao, MD
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Alan L Ho, MD, PhD, 516-564-2022
Alan L Ho, MD, PhD
About this study
Official title: A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas
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.
Read the detailed description
This is a phase II, open-label, non-randomized, multi-institutional study investigating postoperative or adjuvant human epidermal growth factor receptor (HER2)-directed therapy with adjuvant ado-trastuzumab emtansine (T-DM1) in HER2-positive salivary gland carcinomas (SGC).
This research study is:
- Studying the use of T-DM1 in combination with radiation and chemotherapy; and the use of maintenance T-DM1 alone for up to a year after surgery
- Evaluating the effectiveness, safety, and toxicity of T-DM1
T-DM1 is a specialized antibody targeting HER-2 (a protein that is expressed in some breast and salivary gland cancers). The drug is a HER-2 antibody that is bound to a chemotherapy agent (DM1) and delivered intravenously. T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way. This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers.
The U.S. Food and Drug Administration (FDA) has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses (for breast cancers that express HER2 protein).
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
This research study involves radiation, chemotherapy, and targeted therapy given after surgery for up to 1-year, and participants will be followed for 3 years.
It is expected that about 55 people will take part in this research study.
Genentech is supporting this research study by providing the research study drug, T-DM1.
- Conditions
- Salivary Gland Cancer, HER2 Gene Mutation
- Being tested
- Ado-trastuzumab (T) emtansine (T-DM1), Standard of Care Radiotherapy, Standard of Care Chemotherapy
- Keywords
- Salivary Gland Cancer, HER2 Gene Mutation
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ado-trastuzumab (T) emtansine (T-DM1)Drug
Also called Kadcyla
Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
Standard of Care RadiotherapyRadiation
Also called Radiation
Radiotherapy to shrink or kill tumors
Standard of Care ChemotherapyDrug
Also called Cisplatin, carboplatin
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer | Experimental | 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. Receives: Drug: Ado-trastuzumab (T) emtansine (T-DM1); Radiation: Standard of Care Radiotherapy; Drug: Standard of Care Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Year Disease-free survival (DFS) Rate
Kaplan-Meier method will be used to estimate 2 Year Disease-free survival (DFS) Rate
Measured: 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
Secondary outcomes (3)
Adverse Events
Evaluate adverse events for patient receiving T-DM1, defined as adverse events of all grades utilizing CTCAE v5
Measured: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Overall survival (OS) Rate
Overall Survival (OS) estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).
Measured: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Distant metastatic-free survival (DMFS) Rate
Distant metastatic-free survival (DMFS) Rate estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).
Measured: Time from study registration to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start24 Dec 2020
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Glenn J. Hanna, Dana-Farber Cancer Institute
- Investigators
- Glenn J Hanna, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620187
- Sponsor's protocol ID
- 20-432
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas
- ClinicalTrials.gov ID
- NCT04620187
- Acronym / sponsor ID
- 20-432
- Conditions
- Salivary Gland Cancer, HER2 Gene Mutation
- Keywords
- Salivary Gland Cancer, HER2 Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II, open-label, non-randomized, multi-institutional study investigating postoperative or adjuvant human epidermal growth factor receptor (HER2)-directed therapy with adjuvant ado-trastuzumab emtansine (T-DM1) in HER2-positive salivary gland carcinomas (SGC).
This research study is:
- Studying the use of T-DM1 in combination with radiation and chemotherapy; and the use of maintenance T-DM1 alone for up to a year after surgery
- Evaluating the effectiveness, safety, and toxicity of T-DM1
T-DM1 is a specialized antibody targeting HER-2 (a protein that is expressed in some breast and salivary gland cancers). The drug is a HER-2 antibody that is bound to a chemotherapy agent (DM1) and delivered intravenously. T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way. This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers.
The U.S. Food and Drug Administration (FDA) has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses (for breast cancers that express HER2 protein).
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
This research study involves radiation, chemotherapy, and targeted therapy given after surgery for up to 1-year, and participants will be followed for 3 years.
It is expected that about 55 people will take part in this research study.
Genentech is supporting this research study by providing the research study drug, T-DM1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer | Experimental | Drug: Ado-trastuzumab (T) emtansine (T-DM1), Radiation: Standard of Care Radiotherapy, Drug: Standard of Care ChemotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
- Age 18 years or older
- ECOG performance status ≤ 1 (Karnofsky ≥ 60%, see Appendix A)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ado-trastuzumab (T) emtansine (T-DM1)Also: KadcylaIntravenous infusion ever 21 days (3weeks) for 1 year (52 weeks) | Drug | Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer |
| Standard of Care RadiotherapyAlso: RadiationRadiotherapy to shrink or kill tumors | Radiation | Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer |
| Standard of Care ChemotherapyAlso: Cisplatin, carboplatinIntravenous injection | Drug | Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer |
Primary outcome
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
Kaplan-Meier method will be used to estimate 2 Year Disease-free survival (DFS) Rate
3 secondary outcomes
Adverse Events
Time frame: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Overall survival (OS) Rate
Time frame: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Distant metastatic-free survival (DMFS) Rate
Time frame: Time from study registration to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Salivary Gland Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn J Hanna, MD principal investigator
Dana-Farber Cancer Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ado-trastuzumab (T) emtansine (T-DM1) in people with Salivary Gland Cancer and HER2 Gene Mutation, run by Dana-Farber Cancer Institute at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenn J Hanna, MD (617-632-3090, glenn_hanna@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.