What is the mechanism of action of this treatment?

The most common treatments for Salivary Gland Cancer include surgery, radiation therapy, and systemic therapies such as chemotherapy and targeted therapies. Ado-trastuzumab emtansine (T-DM1) is a targeted therapy that combines trastuzumab, an antibody that binds to the HER2 receptor on cancer cells, with DM1, a cytotoxic agent. This combination allows for the direct delivery of the cytotoxic agent to the cancer cells, minimizing damage to healthy cells. This mechanism is particularly important for Salivary Gland Cancer patients as it offers a more precise treatment option, potentially reducing side effects and improving outcomes by specifically targeting cancer cells overexpressing HER2.

What side effects are associated with this type of intervention?

Common side effects of treatments for salivary gland cancer, particularly those similar to Ado-trastuzumab emtansine (T-DM1), include fatigue, nausea, musculoskeletal pain, thrombocytopenia, elevated liver enzymes, and peripheral neuropathy. Cardiac toxicity is also a concern with HER2-targeted therapies, requiring regular cardiac monitoring.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Salivary Gland Cancer that are directly analogous to Ado-trastuzumab emtansine (T-DM1). However, T-DM1 itself is being studied for its safety and efficacy in treating HER2-positive salivary gland cancer. This investigational approach leverages the mechanism of antibody-drug conjugates, which target the HER2 receptor and deliver the cytotoxic agent DM1 to cancer cells. Other similar treatments for different cancers include trastuzumab deruxtecan, another HER2-targeted antibody-drug conjugate approved for HER2-positive breast cancer.

What other types of research exist?

Promising novel alternatives to Ado-trastuzumab emtansine (T-DM1) for Salivary Gland Cancer patients include Trastuzumab Deruxtecan (T-DXd), which has shown antitumor activity and safety in HER2-positive cancers, and Pembrolizumab plus Cetuximab, which is being investigated for treatment-refractory metastatic head and neck cancers. These alternatives are based on recent clinical trials and ongoing research.

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Monoclonal Antibodies

T-DM1 + Chemoradiation for Salivary Gland Cancer

Phase 2

Recruiting

Led By Glenn J Hanna, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

ECOG performance status ≤ 1 (Karnofsky ≥ 60%, see Appendix A)

Must not have

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.

Active or uncontrolled infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special drug called T-DM1 combined with regular cancer treatments in patients with HER2-positive salivary gland cancer. The drug targets cancer cells specifically and delivers chemotherapy directly to them. The goal is to see if this combination is safe and effective in preventing cancer recurrence. T-DM1 has shown effectiveness in treating HER2-positive cancers, including breast and salivary gland cancers, by targeting cancer cells and delivering chemotherapy directly to them.

Who is the study for?

Adults with HER2-positive salivary gland cancer that can be surgically removed, and who haven't had prior HER2 therapy or chemotherapy/radiotherapy for head and neck cancer. They must have good organ function, not be pregnant or breastfeeding, willing to provide tissue and blood samples, and able to sign consent. Men must use effective contraception.

What is being tested?

The trial is testing the safety and effectiveness of Ado-trastuzumab emtansine (T-DM1) combined with standard chemoradiation in treating resectable HER2-positive salivary gland carcinomas. It also looks at T-DM1's impact on preventing cancer recurrence.

What are the potential side effects?

Possible side effects include liver issues, heart problems like reduced pumping ability, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, infusion-related reactions, and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am mostly self-sufficient and can carry out daily activities.

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My salivary gland cancer is advanced but can be surgically removed.

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My cancer is HER2 positive.

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My heart's pumping ability is confirmed to be normal before starting treatment.

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My cancer has a high level of HER2 according to a specific test.

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My tumor shows a HER2 intensity of 2 or 3+.

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My cancer has a specific HER2 or ERBB2 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I do not have any active or uncontrolled infections.

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I have received radiation or chemotherapy for head and neck cancer.

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My cancer is either at an early stage, very advanced, or cannot be removed by surgery.

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I have received treatments specifically targeting HER2 in the past.

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease

Secondary study objectives

Adverse Events

Distant metastatic-free survival (DMFS) Rate

Overall survival (OS) Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard of Care + T-DM1 in HER2-Positive Salivary Gland CancerExperimental Treatment3 Interventions

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 3 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care Chemotherapy

2014

Completed Phase 2

~270

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Salivary Gland Cancer include surgery, radiation therapy, and systemic therapies such as chemotherapy and targeted therapies. Ado-trastuzumab emtansine (T-DM1) is a targeted therapy that combines trastuzumab, an antibody that binds to the HER2 receptor on cancer cells, with DM1, a cytotoxic agent. This combination allows for the direct delivery of the cytotoxic agent to the cancer cells, minimizing damage to healthy cells. This mechanism is particularly important for Salivary Gland Cancer patients as it offers a more precise treatment option, potentially reducing side effects and improving outcomes by specifically targeting cancer cells overexpressing HER2.

First-in-Human, Phase 1 Dose-Escalation Study of Biparatopic Anti-HER2 Antibody-Drug Conjugate MEDI4276 in Patients with HER2-positive Advanced Breast or Gastric Cancer.Second-Line Treatment of Her2-Positive Metastatic Breast Cancer: Trastuzumab beyond Progression or Lapatinib? A Population Based Cohort Study.Trastuzumab emtansine in breast cancer.